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Condition of Approval Study (COAST)

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ClinicalTrials.gov Identifier: NCT00517751
Recruitment Status : Terminated (Due to Medtronic's voluntary withdrawal of PMA P040001 for X-STOP systems; post-approval study costs outweighed business benefits for marketing X-STOP in US.)
First Posted : August 17, 2007
Results First Posted : February 12, 2016
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics ( Medtronic Spine LLC )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lumbar Spinal Stenosis
Intervention Device: X-STOP PEEK
Enrollment 176
Recruitment Details Due to early study termination, the final analysis is consistent with the last annual report submission to the FDA and data reported on FDA’s post-approval webpage reporting on 162 of 176 enrolled subjects.
Pre-assignment Details  
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description In this arm, patients underwent X-STOP PEEK surgery.
Period Title: Overall Study
Started 162
Completed 33
Not Completed 129
Reason Not Completed
Death             3
Withdrawal by Subject             37
Lost to Follow-up             4
patient not over due             6
Patient not due for visit             76
Missing             3
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Baseline Participants 162
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 162 participants
71.5  (8.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants
Female
75
  46.3%
Male
87
  53.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 162 participants
American Indian or Alaska Native 0
Asian 1
Black or African American 4
Hispanic or Latino 4
Native Hawaiian or other pacific islander 1
Caucasian 152
Other 0
Height  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 162 participants
67.2  (3.93)
Weight  
Mean (Standard Deviation)
Unit of measure:  Lbs
Number Analyzed 162 participants
188.0  (37.40)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 162 participants
29.3  (4.72)
1.Primary Outcome
Title Treatment Success Rate at 24 Months
Hide Description

Treatment success rate is reported as the percentage of participants who met all of the following criteria:

  1. Clinically significant improvement (by at least 0.5 points) in the Symptom Severity (SS) domain of the Zurich Claudication Questionnaire (ZCQ) compared to preoperative baseline
  2. Clinically significant improvement (by at least 0.5 points) in the Physical Function (PF) domain of the ZCQ compared to pre-operative baseline
  3. Patient satisfaction with treatment defined as a Patient Satisfaction (PS) score < 2.5
  4. No additional surgery for lumbar stenosis performed
  5. Maintenance of distraction
  6. No dislodgement of the implant
  7. No device-related complications
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
At 24 months, 94 subjects were evaluable for overall treatment success. Once subjects failed on additional surgery for lumbar stenosis or dislodgement of the implant or device-related complications, they failed at later visits no matter whether they had data or not.
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description:
In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: percentage of participants
30.9
2.Secondary Outcome
Title Treatment Success Rate at 60 Months
Hide Description

Treatment success rate is reported as the percentage of participants who met all of the following criteria:

  1. Clinically significant improvement (by at least 0.5 points) in the Symptom Severity (SS) domain of the ZCQ compared to preoperative baseline
  2. Clinically significant improvement (by at least 0.5 points) in the Physical Function (PF) domain of the ZCQ compared to pre-operative baseline
  3. Patient satisfaction with treatment defined as a Patient Satisfaction (PS) score < 2.5
  4. No additional surgery for lumbar stenosis performed
  5. Maintenance of distraction
  6. No dislodgement of the implant
  7. No device-related complications
Time Frame 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
At 60 months, 62 subjects were evaluable for overall treatment success. Once subjects failed on additional surgery for lumbar stenosis or dislodgement of the implant or device-related complications, they failed at later visits no matter whether they had data or not.
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description:
In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: percentage of participants
24.2
3.Secondary Outcome
Title Symptom Severity (SS) Scores Measured by Zurich Claudication Questionnaire (ZCQ)
Hide Description ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment PS. SS Score is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance) in ZCQ. The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire, ranging from 1 to 5. A lower score represents a better outcome/condition. If more than two items were missing, the SS score was considered as missing.
Time Frame Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description:
In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Participants Analyzed 162
Mean (Standard Deviation)
Unit of Measure: units on a scale
SS score baseline (n=161) 3.29  (0.58)
SS score at 6 weeks (n=151) 2.10  (0.70)
SS score at 12 months (n=103) 2.26  (0.77)
SS score at 24 months (n=88) 2.38  (0.85)
SS score at 36 months (n=71) 2.25  (0.78)
SS score at 48 months (n=59) 2.32  (0.81)
SS score at 60 months (n=46) 2.38  (0.89)
4.Secondary Outcome
Title Success Rate in Symptom Severity (SS) Domain of Zurich Claudication Questionnaire (ZCQ)
Hide Description Success rate in SS domain of ZCQ is reported as percentage of participants who had success in SS domain of the ZCQ. The SS success was defined as clinically significant improvement by at least 0.5 point in SS score compared to preoperative baseline.
Time Frame 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description:
In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Participants Analyzed 162
Measure Type: Number
Unit of Measure: percentage of participants
SS success at 6 weeks (n=150) 78.0
SS success at 12 months (n=102) 71.6
SS success at 24 months (n=87) 62.1
SS success at 36 months (n=70) 64.3
SS success at 48 months (n=59) 61.0
SS success at 60 months (n=46) 56.5
5.Secondary Outcome
Title Physical Function (PF) Scores Measured by Zurich Claudication Questionnaire (ZCQ)
Hide Description PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. If more than one item were missing, the PF score was considered as missing.
Time Frame Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description:
In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Participants Analyzed 162
Mean (Standard Deviation)
Unit of Measure: units on a scale
PF score at baseline (n=162) 2.67  (0.36)
PF score at 6 weeks (n=150) 1.79  (0.60)
PF score at 12 months (n=103) 1.71  (0.62)
PF score at 24 months (n=87) 1.89  (0.69)
PF score at 36 months (n=71) 1.93  (0.76)
PF score at 48 months (n=59) 1.87  (0.67)
PF score at 60 months (n=46) 1.92  (0.79)
6.Secondary Outcome
Title Success Rate in Physical Function (PF) Domain of Zurich Claudication Questionnaire (ZCQ)
Hide Description Success rate in PF domain of ZCQ is reported as percentage of participants who had success in PF domain of ZCQ. The PF success was defined as clinically significant improvement by at least 0.5 points in PF score compared to preoperative baseline.
Time Frame 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description:
In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Participants Analyzed 162
Measure Type: Number
Unit of Measure: percentage of participants
PF success at 6 weeks (n=150) 70.7
PF success at 12 months (n=103) 71.8
PF success at 24 months (n=87) 59.8
PF success at 36 months (n=71) 56.3
PF success at 48 months (n=59) 61.0
PF success at 60 months (n=46) 54.3
7.Secondary Outcome
Title Patient Satisfaction (PS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) at Post Treatment
Hide Description PS score is the mean score of 6 questions of ZCQ, ranging from 1 to 4 if the number of responses exceeded four. A lower score represents a better outcome. Patients with PS score less than 2.5 at postoperative evaluation were considered positive, which implied that patients were satisfied with their treatment.
Time Frame 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description:
In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Participants Analyzed 162
Mean (Standard Deviation)
Unit of Measure: units on a scale
PS score at 6 weeks (n=150) 1.75  (0.74)
PS score at 12 months (n=103) 1.78  (0.75)
PS score at 24 months (n=88) 1.90  (0.81)
PS score at 36 months (n=70) 1.84  (0.81)
PS score at 48 months (n=59) 1.89  (0.90)
PS score at 60 months (n=46) 1.91  (0.90)
8.Secondary Outcome
Title Success Rate in Patient Satisfaction (PS) Domain of Zurich Claudication Questionnaire (ZCQ) at Post Treatment
Hide Description Success rate in PS domain of ZCQ at post treatment is reported as the percentage of participants who had success in PS domain of ZCQ. The PS success was defined as PS score less than 2.5.
Time Frame 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description:
In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Participants Analyzed 162
Measure Type: Number
Unit of Measure: percentage of participants
PS success at 6 weeks (n=150) 81.3
PS success at 12 months (n=103) 80.6
PS success at 24 months (n=88) 72.7
PS success at 36 months (n=70) 72.9
PS success at 48 months (n=59) 67.8
PS success at 60 months (n=46) 69.6
9.Secondary Outcome
Title Oswestry Disability Index (ODI) Score
Hide Description ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).
Time Frame Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description:
In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Participants Analyzed 162
Mean (Standard Deviation)
Unit of Measure: units on a scale
ODI score at baseline (n=162) 38.81  (14.11)
ODI score at 6 weeks (n=151) 22.98  (16.23)
ODI score at 12 months (n=103) 20.34  (16.27)
ODI score at 24 months (n=88) 23.99  (17.08)
ODI score at 36 months (n=71) 23.04  (17.23)
ODI score at 48 months (n=59) 25.27  (18.22)
ODI score at 60 months (n=46) 24.88  (18.53)
10.Secondary Outcome
Title General Health Status -- SF-36 PCS
Hide Description The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS is between 0 and 100, with higher scores denoting better quality of life.
Time Frame Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description:
In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Participants Analyzed 162
Mean (Standard Deviation)
Unit of Measure: units on a scale
SF-36 PCS at baseline (n=162) 27.1  (6.8)
SF-36 PCS at 6 week (n=150) 36.3  (10.5)
SF-36 PCS at 12 months (n=103) 38.4  (12.2)
SF-36 PCS at 24 months (n=88) 35.2  (12.0)
SF-36 PCS at 36 months (n=70) 36.4  (12.5)
SF-36 PCS at 48 months (n=58) 35.7  (11.8)
SF-36 PCS at 60 months (n=46) 35.6  (12.6)
11.Secondary Outcome
Title General Health Status -- SF-36 MCS
Hide Description MCS score is between 0 and 100, with higher scores denoting better quality of life.
Time Frame Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description:
In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Participants Analyzed 162
Mean (Standard Deviation)
Unit of Measure: units on a scale
SF-36 MCS at baseline (n=162) 51.5  (10.8)
SF-36 MCS at 6 weeks (n=150) 54.6  (9.5)
SF-36 MCS at 12 months (n=103) 53.8  (10.1)
SF-36 MCS at 24 months (n=88) 53.4  (11.1)
SF-36 MCS at 36 months (n=70) 54.6  (10.8)
SF-36 MCS at 48 months (n=58) 54.1  (11.9)
SF-36 MCS at 60 months (n=46) 52.8  (12.5)
12.Secondary Outcome
Title Back Pain in Numerical Rating Scales (NRS)
Hide Description Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."
Time Frame Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description:
In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Participants Analyzed 162
Mean (Standard Deviation)
Unit of Measure: units on a scale
Back pain at baseline (n=161) 6.4  (2.4)
Back pain at 6 weeks (n=150) 3.2  (2.4)
Back pain at 12 months (n=103) 3.5  (2.8)
Back pain at 24 months (n=88) 4.0  (3.0)
Back pain at 36 months (n=70) 3.7  (2.9)
Back pain at 48 months (n=59) 3.7  (3.2)
Back pain at 60 months (n=46) 3.5  (3.0)
13.Secondary Outcome
Title Left Leg Pain in Numerical Rating Scales (NRS)
Hide Description Left leg pain was measured using NRS. Patients rated their leg pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."
Time Frame Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description:
In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Participants Analyzed 162
Mean (Standard Deviation)
Unit of Measure: units on a scale
Left leg pain at baseline (n=161) 5.5  (3.0)
Left leg pain at 6 weeks (n=150) 1.9  (2.6)
Left leg pain at 12 months (n=103) 2.1  (2.8)
Left leg pain at 24 months (n=87) 2.7  (2.9)
Left leg pain at 36 months (n=70) 2.8  (3.0)
Left leg pain at 48 months (n=59) 2.5  (2.9)
Left leg pain at 60 months (n=46) 2.7  (3.1)
14.Secondary Outcome
Title Right Leg Pain in Numerical Rating Scales (NRS)
Hide Description Right leg pain was measured using NRS. Patients rated their leg pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."
Time Frame Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description:
In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Participants Analyzed 162
Mean (Standard Deviation)
Unit of Measure: units on a scale
Right leg pain at baseline (n=161) 5.5  (3.0)
Right leg pain at 6 weeks (n=150) 2.0  (2.5)
Right leg pain at 12 months (n=103) 2.4  (2.7)
Right leg pain at 24 months (n=88) 2.9  (3.1)
Right leg pain at 36 months (n=70) 2.3  (2.7)
Right leg pain at 48 months (n=59) 2.7  (3.2)
Right leg pain at 60 months (n=46) 2.8  (3.2)
15.Other Pre-specified Outcome
Title Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 24 Months
Hide Description The Pfirrmann Grading System is descriptive and grades the status on an intervertebral disc as visualized with MRI using a 5-point system (grade I, II, III, IV or V). Grade I: disc is homogeneous with bright hyper-intense white signal intensity and normal disc height. Grade V: disc is inhomogeneous with hypo-intense black signal intensity and there is no more distinction between the nucleus and annulus, the disc space is collapsed. The percent of subjects with Pfirrmann grades increased from baseline at 24 months is reported.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
At 24 months, 53 subjects were evaluable for Pfirrmann Grade assessment.
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description:
In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: percentage of participants
9.4
16.Other Pre-specified Outcome
Title Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 60 Months
Hide Description The Pfirrmann Grading System is descriptive and grades the status on an intervertebral disc as visualized with MRI using a 5-point system (grade I, II, III, IV or V). Grade I: disc is homogeneous with bright hyper-intense white signal intensity and normal disc height. Grade V: disc is inhomogeneous with hypo-intense black signal intensity and there is no more distinction between the nucleus and annulus, the disc space is collapsed. The percent of subjects with Pfirrmann grades increased from baseline at 60 months is reported.
Time Frame 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
At 60 months, 16 subjects were evaluable for Pfirrmann Grade assessment.
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description:
In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: percentage of participants
0.0
17.Other Pre-specified Outcome
Title Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 24 Months
Hide Description The percent of subjects with Pfirrmann grades increased from baseline at adjacent levels at 24 months is reported.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
At 24 months, 53 subjects were evaluable for Pfirrmann Grade assessment.
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description:
In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: percentage of participants
9.4
18.Other Pre-specified Outcome
Title Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 60 Months
Hide Description The percent of subjects with Pfirrmann grades increased from baseline at adjacent levels at 60 months is reported.
Time Frame 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
At 60 months, 16 subjects were evaluable for Pfirrmann Grade assessment.
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description:
In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: percentage of participants
25.0
19.Other Pre-specified Outcome
Title Percent of Subjects Who Reported Implant-Related Adverse Events
Hide Description [Not Specified]
Time Frame Overall study period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description:
In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Participants Analyzed 162
Measure Type: Number
Unit of Measure: percentage of participants
11.1
20.Other Pre-specified Outcome
Title Percent of Subjects Who Had Any Subsequent Lumbar Spine Surgery
Hide Description [Not Specified]
Time Frame Overall study period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description:
In this arm, patients underwent X-STOP PEEK surgery.
Overall Number of Participants Analyzed 162
Measure Type: Number
Unit of Measure: percentage of participants
19.8
Time Frame Overall study period (up to 60 months)
Adverse Event Reporting Description Due to early study termination, not all subjects were followed through 60 months.
 
Arm/Group Title X-STOP PEEK
Hide Arm/Group Description In this arm, patients will undergo X-STOP PEEK surgery.
All-Cause Mortality
X-STOP PEEK
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
X-STOP PEEK
Affected / at Risk (%) # Events
Total   65/162 (40.12%)    
Blood and lymphatic system disorders   
Anaemia  1/162 (0.62%)  1
Cardiac disorders   
Acute myocardial infarction  1/162 (0.62%)  1
Angina pectoris  1/162 (0.62%)  1
Atrial fibrillation  1/162 (0.62%)  1
Cardiac disorder  1/162 (0.62%)  2
Cardiogenic shock  1/162 (0.62%)  1
Cardiomyopathy  1/162 (0.62%)  1
Coronary artery disease  3/162 (1.85%)  3
Diastolic dysfunction  1/162 (0.62%)  1
Intracardiac thrombus  1/162 (0.62%)  1
Myocardial infarction  3/162 (1.85%)  3
Myocarditis  1/162 (0.62%)  1
Supraventricular tachycardia  1/162 (0.62%)  1
Ventricular tachycardia  1/162 (0.62%)  1
Ear and labyrinth disorders   
Ear pain  1/162 (0.62%)  1
Haematotympanum  1/162 (0.62%)  1
Eye disorders   
Cataract  1/162 (0.62%)  1
Cataract cortical  1/162 (0.62%)  1
Macular hole  1/162 (0.62%)  1
Gastrointestinal disorders   
Diverticulum  1/162 (0.62%)  1
Gastrointestinal haemorrhage  1/162 (0.62%)  1
Gastrooesophageal reflux disease  1/162 (0.62%)  1
Oesophageal ulcer haemorrhage  1/162 (0.62%)  1
Rectal fissure  1/162 (0.62%)  1
General disorders   
Adverse drug reaction  1/162 (0.62%)  1
Death  2/162 (1.23%)  2
Device dislocation  3/162 (1.85%)  3
Device ineffective  1/162 (0.62%)  1
Gait disturbance  1/162 (0.62%)  1
Medical device pain  1/162 (0.62%)  1
Pyrexia  1/162 (0.62%)  1
Infections and infestations   
Anal abscess  1/162 (0.62%)  1
Cellulitis  1/162 (0.62%)  1
Clostridial infection  1/162 (0.62%)  1
Device related infection  2/162 (1.23%)  2
Meningitis bacterial  1/162 (0.62%)  1
Pneumonia  3/162 (1.85%)  3
Post procedural infection  1/162 (0.62%)  1
Postoperative wound infection  2/162 (1.23%)  2
Sepsis  1/162 (0.62%)  1
Wound infection staphylococcal  1/162 (0.62%)  1
Injury, poisoning and procedural complications   
Animal bite  1/162 (0.62%)  1
Ankle fracture  1/162 (0.62%)  1
Fall  3/162 (1.85%)  3
Hip fracture  2/162 (1.23%)  3
Incision site complication  1/162 (0.62%)  1
Injury  1/162 (0.62%)  1
Joint dislocation  2/162 (1.23%)  2
Procedural pain  1/162 (0.62%)  2
Seroma  1/162 (0.62%)  1
Spinal compression fracture  1/162 (0.62%)  1
Spinal fracture  1/162 (0.62%)  1
Toxicity to various agents  1/162 (0.62%)  1
Urinary retention postoperative  1/162 (0.62%)  1
Vascular graft complication  1/162 (0.62%)  1
Wound dehiscence  1/162 (0.62%)  1
Investigations   
Anticoagulation drug level above therapeutic  1/162 (0.62%)  1
Blood magnesium decreased  1/162 (0.62%)  1
Blood pressure decreased  1/162 (0.62%)  1
Blood pressure increased  1/162 (0.62%)  1
Cardiac stress test abnormal  1/162 (0.62%)  1
Metabolism and nutrition disorders   
Metabolic acidosis  1/162 (0.62%)  1
Total fluid volume decreased  1/162 (0.62%)  2
Musculoskeletal and connective tissue disorders   
Back pain  3/162 (1.85%)  3
Cervical spinal stenosis  1/162 (0.62%)  1
Fracture nonunion  1/162 (0.62%)  1
Intervertebral disc degeneration  2/162 (1.23%)  4
Intervertebral disc protrusion  3/162 (1.85%)  3
Joint ankylosis  1/162 (0.62%)  1
Lumbar spinal stenosis  4/162 (2.47%)  4
Muscular weakness  2/162 (1.23%)  2
Musculoskeletal pain  2/162 (1.23%)  2
Osteoarthritis  7/162 (4.32%)  8
Pain in extremity  5/162 (3.09%)  5
Periarthritis  1/162 (0.62%)  1
Rotator cuff syndrome  2/162 (1.23%)  2
Sacroiliitis  1/162 (0.62%)  1
Scoliosis  1/162 (0.62%)  1
Spinal osteoarthritis  1/162 (0.62%)  1
Spondylolisthesis  3/162 (1.85%)  3
Vertebral foraminal stenosis  1/162 (0.62%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer in situ  1/162 (0.62%)  1
Metastatic malignant melanoma  1/162 (0.62%)  1
Morton's neuroma  1/162 (0.62%)  1
Non-hodgkin's lymphoma  1/162 (0.62%)  1
Prostate cancer  1/162 (0.62%)  1
Nervous system disorders   
Carpal tunnel syndrome  2/162 (1.23%)  2
Cerebrovascular accident  3/162 (1.85%)  3
Cervical myelopathy  1/162 (0.62%)  1
Cervicobrachial syndrome  1/162 (0.62%)  1
Dizziness  1/162 (0.62%)  1
Hypoaesthesia  2/162 (1.23%)  2
Intracranial hypotension  1/162 (0.62%)  1
Lumbar radiculopathy  2/162 (1.23%)  2
Radiculopathy  2/162 (1.23%)  2
Sensory disturbance  1/162 (0.62%)  1
Spinal claudication  9/162 (5.56%)  9
Psychiatric disorders   
Delusion  1/162 (0.62%)  1
Hallucination  1/162 (0.62%)  1
Renal and urinary disorders   
Renal failure  1/162 (0.62%)  1
Renal failure acute  1/162 (0.62%)  1
Urinary retention  1/162 (0.62%)  1
Reproductive system and breast disorders   
Cervical polyp  1/162 (0.62%)  1
Respiratory, thoracic and mediastinal disorders   
Aspiration  1/162 (0.62%)  1
Bronchitis  1/162 (0.62%)  1
Chronic obstructive pulmonary disease  1/162 (0.62%)  1
Hypoxia  2/162 (1.23%)  2
Lung infiltration  1/162 (0.62%)  1
Pneumonia  1/162 (0.62%)  1
Pulmonary embolism  1/162 (0.62%)  1
Respiratory failure  2/162 (1.23%)  2
Social circumstances   
Activities of daily living impaired  2/162 (1.23%)  2
Surgical and medical procedures   
Abdominal hernia repair  1/162 (0.62%)  1
Carotid endarterectomy  1/162 (0.62%)  1
External fixation of fracture  1/162 (0.62%)  1
Hip arthroplasty  1/162 (0.62%)  1
Joint dislocation reduction  1/162 (0.62%)  1
Leg amputation  1/162 (0.62%)  1
Medical device removal  20/162 (12.35%)  22
Shoulder arthroplasty  1/162 (0.62%)  1
Vascular disorders   
Aortic aneurysm  1/162 (0.62%)  1
Deep vein thrombosis  1/162 (0.62%)  1
Hematoma  1/162 (0.62%)  1
Hypotension  1/162 (0.62%)  1
Iliac artery thrombosis  1/162 (0.62%)  2
Vascular insufficiency  1/162 (0.62%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.0%
X-STOP PEEK
Affected / at Risk (%) # Events
Total   118/162 (72.84%)    
Blood and lymphatic system disorders   
Anaemia  4/162 (2.47%)  4
Thrombocytopenia  1/162 (0.62%)  1
Cardiac disorders   
Atrial fibrillation  1/162 (0.62%)  1
Bradycardia  1/162 (0.62%)  1
Cardiac failure congestive  1/162 (0.62%)  1
Coronary artery disease  2/162 (1.23%)  2
Diastolic dysfunction  1/162 (0.62%)  1
Tachycardia  1/162 (0.62%)  1
Congenital, familial and genetic disorders   
Gastrointestinal arteriovenous malformation  1/162 (0.62%)  1
Ear and labyrinth disorders   
Ear discomfort  1/162 (0.62%)  1
Vertigo  1/162 (0.62%)  1
Endocrine disorders   
Hypothyroidism  3/162 (1.85%)  3
Eye disorders   
Cataract nuclear  1/162 (0.62%)  1
Corneal bleeding  1/162 (0.62%)  1
Glaucoma  1/162 (0.62%)  1
Macular degeneration  1/162 (0.62%)  1
Vision blurred  1/162 (0.62%)  1
Vitreous floaters  1/162 (0.62%)  1
Gastrointestinal disorders   
Abdominal discomfort  1/162 (0.62%)  1
Abdominal distension  1/162 (0.62%)  1
Abdominal pain  1/162 (0.62%)  1
Abdominal pain lower  1/162 (0.62%)  1
Abdominal pain upper  1/162 (0.62%)  1
Colonic polyp  1/162 (0.62%)  1
Constipation  1/162 (0.62%)  2
Crohn's disease  1/162 (0.62%)  1
Diarrhoea  2/162 (1.23%)  2
Diverticulitis  1/162 (0.62%)  1
Diverticulum  1/162 (0.62%)  1
Duodenal ulcer  1/162 (0.62%)  1
Dyspepsia  1/162 (0.62%)  1
Dysphagia  2/162 (1.23%)  2
Faecal incontinence  1/162 (0.62%)  1
Faecaloma  1/162 (0.62%)  1
Gastritis  1/162 (0.62%)  1
Gastrointestinal infection  1/162 (0.62%)  1
Gastrooesophageal reflux disease  3/162 (1.85%)  3
Haemorrhoids  1/162 (0.62%)  1
Levator syndrome  1/162 (0.62%)  1
Nausea  6/162 (3.70%)  6
Rectal haemorrhage  1/162 (0.62%)  1
Vomiting  2/162 (1.23%)  2
General disorders   
Adverse drug reaction  4/162 (2.47%)  4
Asthenia  1/162 (0.62%)  1
Axillary pain  1/162 (0.62%)  1
Chest pain  2/162 (1.23%)  2
Complication of device insertion  5/162 (3.09%)  5
Device difficult to use  1/162 (0.62%)  1
Device dislocation  3/162 (1.85%)  3
Device material issue  1/162 (0.62%)  1
Fatigue  5/162 (3.09%)  5
Gait disturbance  2/162 (1.23%)  2
Malaise  1/162 (0.62%)  1
Non-cardiac chest pain  2/162 (1.23%)  2
Oedema peripheral  2/162 (1.23%)  3
Pyrexia  1/162 (0.62%)  1
Xerosis  1/162 (0.62%)  1
Immune system disorders   
Autoimmune disorder  1/162 (0.62%)  1
Hypersensitivity  1/162 (0.62%)  1
Infections and infestations   
Acute sinusitis  1/162 (0.62%)  1
Bronchitis  4/162 (2.47%)  4
Candidiasis  1/162 (0.62%)  1
Cystitis  1/162 (0.62%)  1
Gastrointestinal bacterial infection  1/162 (0.62%)  1
Herpes virus infection  1/162 (0.62%)  1
Herpes zoster  5/162 (3.09%)  5
Incision site infection  3/162 (1.85%)  3
Influenza  1/162 (0.62%)  1
Kidney infection  2/162 (1.23%)  2
Laryngitis viral  1/162 (0.62%)  1
Nasopharyngitis  1/162 (0.62%)  1
Oral herpes  1/162 (0.62%)  1
Otitis externa  1/162 (0.62%)  1
Pharyngitis streptococcal  1/162 (0.62%)  1
Pyelonephritis  1/162 (0.62%)  1
Respiratory tract infection bacterial  1/162 (0.62%)  1
Sinusitis  4/162 (2.47%)  7
Tooth abscess  1/162 (0.62%)  1
Upper respiratory tract infection  5/162 (3.09%)  5
Urinary tract infection  6/162 (3.70%)  11
Wound infection staphylococcal  2/162 (1.23%)  2
Injury, poisoning and procedural complications   
Anaemia postoperative  1/162 (0.62%)  1
Back injury  1/162 (0.62%)  1
Cervical vertebral fracture  1/162 (0.62%)  1
Clavicle fracture  1/162 (0.62%)  1
Contusion  2/162 (1.23%)  2
Corneal abrasion  1/162 (0.62%)  1
Dural tear  2/162 (1.23%)  2
Excoriation  2/162 (1.23%)  2
Fall  18/162 (11.11%)  23
Femur fracture  1/162 (0.62%)  1
Gastroenteritis radiation  1/162 (0.62%)  1
Hand fracture  2/162 (1.23%)  2
Incision site complication  1/162 (0.62%)  1
Incision site erythema  2/162 (1.23%)  2
Incision site haemorrhage  1/162 (0.62%)  1
Incision site oedema  1/162 (0.62%)  1
Incision site pain  8/162 (4.94%)  8
Incision site pruritus  1/162 (0.62%)  1
Injury  1/162 (0.62%)  1
Joint injury  1/162 (0.62%)  1
Ligament injury  1/162 (0.62%)  1
Ligament rupture  1/162 (0.62%)  1
Meniscus lesion  1/162 (0.62%)  1
Muscle strain  2/162 (1.23%)  2
Operative haemorrhage  2/162 (1.23%)  2
Postoperative fever  1/162 (0.62%)  2
Postoperative ileus  1/162 (0.62%)  1
Postoperative wound complication  1/162 (0.62%)  1
Procedural pain  2/162 (1.23%)  2
Radius fracture  1/162 (0.62%)  1
Rib fracture  1/162 (0.62%)  1
Road traffic accident  4/162 (2.47%)  4
Scapula fracture  1/162 (0.62%)  1
Seroma  1/162 (0.62%)  1
Soft tissue injury  1/162 (0.62%)  1
Spinal fracture  8/162 (4.94%)  8
Tendonitis  1/162 (0.62%)  1
Upper limb fracture  1/162 (0.62%)  1
Urinary retention postoperative  1/162 (0.62%)  1
Wound secretion  5/162 (3.09%)  6
Investigations   
Blood glucose increased  1/162 (0.62%)  1
Blood potassium increased  1/162 (0.62%)  1
Blood pressure decreased  1/162 (0.62%)  1
Blood pressure increased  3/162 (1.85%)  3
Blood triglycerides increased  2/162 (1.23%)  2
Body temperature increased  1/162 (0.62%)  1
Glysolated haemoglobin increased  1/162 (0.62%)  1
Pulse absent  1/162 (0.62%)  1
Spinal x-ray abnormal  1/162 (0.62%)  1
Weight decreased  2/162 (1.23%)  2
Metabolism and nutrition disorders   
Dehydration  1/162 (0.62%)  1
Diabetes mellitus  2/162 (1.23%)  2
Fluid retention  1/162 (0.62%)  1
Glucose tolerance impaired  1/162 (0.62%)  1
Gout  1/162 (0.62%)  1
Hypercholesterolaemia  1/162 (0.62%)  1
Hyperglycaemia  1/162 (0.62%)  1
Hyperlipidaemia  1/162 (0.62%)  1
Hypokalaemia  1/162 (0.62%)  1
Insulin-requiring type 2 diabetes mellitus  1/162 (0.62%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  17/162 (10.49%)  21
Arthritis  2/162 (1.23%)  2
Back pain  35/162 (21.60%)  49
Bursitis  6/162 (3.70%)  6
Coccydynia  1/162 (0.62%)  1
Dupuytren's contracture  1/162 (0.62%)  1
Facet joint syndrome  1/162 (0.62%)  1
Flank pain  2/162 (1.23%)  2
Groin pain  4/162 (2.47%)  4
Intervertebral disc degeneration  1/162 (0.62%)  1
Intervertebral disc protrusion  3/162 (1.85%)  3
Joint swelling  1/162 (0.62%)  1
Joint contracture  1/162 (0.62%)  1
Joint crepitation  1/162 (0.62%)  1
Joint range of motion decreased  2/162 (1.23%)  2
Lower extremity mass  1/162 (0.62%)  1
Lumbar spinal stenosis  5/162 (3.09%)  5
Metatarsalgia  1/162 (0.62%)  1
Muscle spasms  11/162 (6.79%)  13
Muscle tightness  1/162 (0.62%)  1
Muscular weakness  4/162 (2.47%)  4
Musculoskeletal chest pain  1/162 (0.62%)  1
Musculoskeletal discomfort  1/162 (0.62%)  1
Musculoskeletal pain  10/162 (6.17%)  13
Musculoskeletal stiffness  2/162 (1.23%)  2
Myalgia  5/162 (3.09%)  5
Neck pain  11/162 (6.79%)  11
Osteoarthritis  12/162 (7.41%)  12
Osteopenia  1/162 (0.62%)  1
Osteoporosis  1/162 (0.62%)  1
Pain in extremity  18/162 (11.11%)  19
Periarthritis  2/162 (1.23%)  2
Plantar fasciitis  2/162 (1.23%)  2
Rotator cuff syndrome  3/162 (1.85%)  4
Scoliosis  2/162 (1.23%)  2
Spinal osteoarthritis  3/162 (1.85%)  4
Spondylolisthesis  1/162 (0.62%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Malignant melanoma  1/162 (0.62%)  1
Morton's neuroma  1/162 (0.62%)  1
Prostate cancer  1/162 (0.62%)  1
Seborrhoeic keratosis  3/162 (1.85%)  4
Nervous system disorders   
Amnesia  1/162 (0.62%)  1
Carpal tunnel syndrome  2/162 (1.23%)  3
Cerebral atrophy  1/162 (0.62%)  1
Cerebral small vessel ischaemic disease  1/162 (0.62%)  1
Coordination abnormal  1/162 (0.62%)  1
Diabetic neuropathy  1/162 (0.62%)  1
Dizziness  2/162 (1.23%)  3
Headache  1/162 (0.62%)  1
Hypoaesthesia  6/162 (3.70%)  9
Lethargy  1/162 (0.62%)  1
Lumbar radiculopathy  2/162 (1.23%)  2
Multiple sclerosis  1/162 (0.62%)  1
Neuralgia  1/162 (0.62%)  1
Neuropathy peripheral  1/162 (0.62%)  1
Paraesthesia  3/162 (1.85%)  4
Poor quality sleep  1/162 (0.62%)  1
Presyncope  1/162 (0.62%)  1
Radicular pain  5/162 (3.09%)  5
Senile dementia  1/162 (0.62%)  1
Spinal claudication  8/162 (4.94%)  12
Tarsal tunnel syndrome  1/162 (0.62%)  1
Psychiatric disorders   
Agitation  1/162 (0.62%)  1
Anxiety  2/162 (1.23%)  2
Depression  2/162 (1.23%)  2
Flashback  1/162 (0.62%)  1
Grief reaction  1/162 (0.62%)  1
Insomnia  3/162 (1.85%)  3
Sleep disorder  2/162 (1.23%)  2
Renal and urinary disorders   
Dysuria  2/162 (1.23%)  2
Haematuria  1/162 (0.62%)  1
Micturition urgency  1/162 (0.62%)  2
Nocturia  1/162 (0.62%)  1
Pollakiuria  1/162 (0.62%)  1
Renal failure  1/162 (0.62%)  1
Strangury  1/162 (0.62%)  1
Urinary retention  3/162 (1.85%)  3
Reproductive system and breast disorders   
Benign prostatic hyperplasia  1/162 (0.62%)  1
Breast cyst  1/162 (0.62%)  1
Breast mass  1/162 (0.62%)  1
Erectile dysfunction  2/162 (1.23%)  2
Gynaecomastia  1/162 (0.62%)  1
Vulvovaginal dryness  1/162 (0.62%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma  1/162 (0.62%)  1
Bronchial hyperreactivity  1/162 (0.62%)  1
Bronchitis  1/162 (0.62%)  1
Chronic obstructive pulmonary disease  2/162 (1.23%)  2
Cough  2/162 (1.23%)  2
Dysphonia  2/162 (1.23%)  2
Dyspnoea  2/162 (1.23%)  2
Dysponea exertional  1/162 (0.62%)  1
Hiccups  1/162 (0.62%)  2
Interstitial lung disease  1/162 (0.62%)  1
Nasal congestion  1/162 (0.62%)  1
Pneumonia  1/162 (0.62%)  1
Sleep apnoea syndrome  2/162 (1.23%)  2
Tonsillar disorder  1/162 (0.62%)  1
Vocal cord disorder  1/162 (0.62%)  1
Skin and subcutaneous tissue disorders   
Actinic keratosis  4/162 (2.47%)  4
Dermatitis  1/162 (0.62%)  1
Dermatitis contact  1/162 (0.62%)  1
Erythema  1/162 (0.62%)  1
Hyperkeratosis  1/162 (0.62%)  1
Nail disorder  1/162 (0.62%)  1
Pruritus  1/162 (0.62%)  1
Rash  2/162 (1.23%)  2
Seborrheic dermatitis  1/162 (0.62%)  1
Surgical and medical procedures   
Corneal transplant  1/162 (0.62%)  1
Endodontic procedure  1/162 (0.62%)  1
Hip arthroplasty  1/162 (0.62%)  1
Incisional drainage  1/162 (0.62%)  1
Knee arthroplasty  1/162 (0.62%)  1
Medical device removal  1/162 (0.62%)  1
Vascular disorders   
Arterial thrombosis  1/162 (0.62%)  1
Arteriovenous fistula  1/162 (0.62%)  1
Haematoma  1/162 (0.62%)  1
Hypotension  1/162 (0.62%)  1
Peripheral coldness  2/162 (1.23%)  2
Study strengths include collection of 5-year data and radiographic examinations. Study weaknesses include single-arm design and early termination of the study without reaching the desired sample size.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Department
Organization: Medtronic Spinal and biologics
Phone: 1800-876-3133 ext 6068
EMail: msbkclinicalresearch@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Spinal and Biologics ( Medtronic Spine LLC )
ClinicalTrials.gov Identifier: NCT00517751     History of Changes
Other Study ID Numbers: LSS-006-COA
First Submitted: August 15, 2007
First Posted: August 17, 2007
Results First Submitted: December 1, 2015
Results First Posted: February 12, 2016
Last Update Posted: January 2, 2018