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Study Evaluating the Safety and Effectiveness of the FLEXUS(TM) Interspinous Spacer

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ClinicalTrials.gov Identifier: NCT01156675
Recruitment Status : Terminated
First Posted : July 5, 2010
Results First Posted : April 27, 2018
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Globus Medical Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Lumbar Spinal Stenosis
Interventions Device: FLEXUS(TM) Interspinous Spacer
Device: XSTOP® Interspinous Spacer
Enrollment 215

Recruitment Details  
Pre-assignment Details  
Arm/Group Title FLEXUS™ Interspinous Spacer X-STOP® Interspinous Spacer No Treatment
Hide Arm/Group Description FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer Not treated with FLEXUS or X-STOP
Period Title: Overall Study
Started 107 106 2
Completed 73 81 0
Not Completed 34 25 2
Reason Not Completed
Death             5             3             0
No data             29             22             2
Arm/Group Title FLEXUS™ Interspinous Spacer X-STOP® Interspinous Spacer No Treatment Total
Hide Arm/Group Description FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the X-STOP® Spacer Not treated with FLEXUS or X-STOP Total of all reporting groups
Overall Number of Baseline Participants 107 106 2 215
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 106 participants 2 participants 215 participants
68.2  (8.93) 67.3  (8.88) 71.5  (4.95) 67.8  (8.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 106 participants 2 participants 215 participants
Female
54
  50.5%
46
  43.4%
1
  50.0%
101
  47.0%
Male
53
  49.5%
60
  56.6%
1
  50.0%
114
  53.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 107 participants 106 participants 2 participants 215 participants
Caucasian
98
  91.6%
102
  96.2%
2
 100.0%
202
  94.0%
Black
7
   6.5%
3
   2.8%
0
   0.0%
10
   4.7%
Asian
1
   0.9%
0
   0.0%
0
   0.0%
1
   0.5%
Hispanic
1
   0.9%
0
   0.0%
0
   0.0%
1
   0.5%
Other
0
   0.0%
1
   0.9%
0
   0.0%
1
   0.5%
Weight (lbs)  
Mean (Standard Deviation)
Unit of measure:  Lbs
Number Analyzed 107 participants 106 participants 2 participants 215 participants
181.8  (33.87) 193.2  (37.75) 195.0  (77.78) 187.5  (36.45)
Height (inches)  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 107 participants 106 participants 2 participants 215 participants
67.0  (3.62) 67.2  (3.94) 66.0  (11.31) 67.1  (3.84)
1.Primary Outcome
Title Number of Participants With Less Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Score
Hide Description

Change in the Zurich Claudication Questionnaire (ZCQ) score at 24 months compared with the score at baseline as follows:

  • Change of >0.5 points in Physical Function on a scale of 1-4 points (lower values are considered a better outcome)
  • Change of >0.5 points in Symptom Severity on a scale of 1-5 points (lower values are considered a better outcome)
  • Satisfaction of <2.5 points on a scale of 1-4 points (lower values are considered a better outcome) The Zurich Claudication Questionnaire is a three part form that quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Overall Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow module. The discrepancy in the numbers is due to an additional subject having ZCQ data at 24 months in the FLEXUS arm and one less subject with ZCQ data at 24 months in the X-STOP group. No data was collected for the "No Treatment" arm.
Arm/Group Title FLEXUS™ Interspinous Spacer X-STOP® Interspinous Spacer No Treatment
Hide Arm/Group Description:
FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
Not treated with FLEXUS or X-STOP
Overall Number of Participants Analyzed 74 80 0
Measure Type: Count of Participants
Unit of Measure: Participants
42
  56.8%
50
  62.5%
0
2.Primary Outcome
Title Number of Participants With a Successful Neurologic Status
Hide Description

Neurological status is based on four types of measurement parameters: motor, sensory, reflexes, and special assessments. Each parameter will be coded as follows:

Motor 0 Total Paralysis

  1. Palpable or Visible Contraction
  2. Active Movement, Gravity Eliminated
  3. Active Movement, Against Gravity
  4. Active Movement, Against Some Resistance
  5. Active Movement, Against Full Resistance

Sensory 0 Absent

  1. Impaired
  2. Normal

Reflexes 0 Absent or Trace

  1. Hyper-reflexic
  2. Normal or hypo-reflexic

Straight Leg Raise 0 0°-70° (abnormal)

1 >70°-90° (normal)

If all evaluations for the parameter are determined to be normal, then the parameter is given a normal status. If any evaluations for the parameter are abnormal, then the parameter is given an abnormal status. The overall neurological status will be considered a success if and only if all the four parameters are stable or improved.

Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to two less subjects having neurologic status data at 24 months in the FLEXUS arm and one less subject with neurologic status data at 24 months in the X-STOP arm. No data was collected for the "No Treatment" arm.
Arm/Group Title FLEXUS™ Interspinous Spacer X-STOP® Interspinous Spacer No Treatment
Hide Arm/Group Description:
FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
Not treated with FLEXUS or X-STOP
Overall Number of Participants Analyzed 71 80 0
Measure Type: Count of Participants
Unit of Measure: Participants
60
  84.5%
69
  86.3%
0
3.Primary Outcome
Title Number of Participants With no Additional Surgery for Lumbar Spinal Stenosis at the Spinal Level That Was Treated
Hide Description Measures the number of participants who did not have another surgery for treatment of lumbar spinal stenosis at the same spinal level that was originally treated. Data, including adverse events, were monitored, evaluated and assessed for evidence of additional surgical treatment at the spinal level that was originally treated.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Overall Number of Participants Analyzed in the FLEXUS arm and X-STOP arm is the number of subjects who started the Study in the respective arm. No data was collected for the "No Treatment" arm.
Arm/Group Title FLEXUS™ Interspinous Spacer X-STOP® Interspinous Spacer No Treatment
Hide Arm/Group Description:
FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
Not treated with FLEXUS or X-STOP
Overall Number of Participants Analyzed 107 106 0
Measure Type: Count of Participants
Unit of Measure: Participants
90
  84.1%
99
  93.4%
0
4.Primary Outcome
Title Number of Participants With an Absence of Implant-related Complications
Hide Description

Absence of implant-related complications, including device dislodgement, defined as:

  • Failure of implant material (e.g. fracture);
  • Implant migration outside of the interspinous space (posteriorly beyond the posterior margin of the spinous processes, anteriorly within the spinal canal, or laterally more than half of the implant width); or
  • Other complications that can be specifically associated with the implanted device.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Overall Number of Participants Analyzed in the FLEXUS arm and X-STOP arm is the number of subjects who started the Study in the respective arms. No data was collected for the "No Treatment" arm.
Arm/Group Title FLEXUS™ Interspinous Spacer X-STOP® Interspinous Spacer No Treatment
Hide Arm/Group Description:
FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
Not treated with FLEXUS or X-STOP
Overall Number of Participants Analyzed 107 106 0
Measure Type: Count of Participants
Unit of Measure: Participants
84
  78.5%
97
  91.5%
0
5.Secondary Outcome
Title Mean Oswestry Disability Index (ODI) at 24 Months
Hide Description The Oswestry Disability Index (ODI) questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The subject chooses the statement which most closely resembles their situation. Each question is scored on a scale of 0–5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. Scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to ten less subjects having ODI data at 24 months in the FLEXUS arm and four less subject with ODI data at 24 months in the X-STOP arm. No data was collected for the "No Treatment" arm.
Arm/Group Title FLEXUS™ Interspinous Spacer X-STOP® Interspinous Spacer No Treatment
Hide Arm/Group Description:
FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
Not treated with FLEXUS or X-STOP
Overall Number of Participants Analyzed 63 77 0
Mean (Standard Deviation)
Unit of Measure: score
19.2  (17.97) 17.4  (14.15)
6.Secondary Outcome
Title Mean Visual Analog Scale (VAS) - Back Pain at 24 Months
Hide Description The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with “no pain” on the left border and “as severe as it could be” on the right border. The subject is instructed to make a mark along the line to represent the intensity of back pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to ten less subjects having ODI data at 24 months in the FLEXUS arm and four less subject with ODI data at 24 months in the X-STOP arm. No data was collected for the "No Treatment" arm.
Arm/Group Title FLEXUS™ Interspinous Spacer X-STOP® Interspinous Spacer No Treatment
Hide Arm/Group Description:
FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
Not treated with FLEXUS or X-STOP
Overall Number of Participants Analyzed 62 77 0
Mean (Standard Deviation)
Unit of Measure: millimeters
20.2  (27.77) 18.8  (27.36)
7.Secondary Outcome
Title Mean Visual Analog Scale (VAS) - Right Leg Pain at 24 Months
Hide Description The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with “no pain” on the left border and “as severe as it could be” on the right border. The subject is instructed to make a mark along the line to represent the intensity of right leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to eleven less subjects having VAS data at 24 months in the FLEXUS arm and four less subject with VAS data at 24 months in the X-STOP arm. No data was collected for the "No Treatment" arm.
Arm/Group Title FLEXUS™ Interspinous Spacer X-STOP® Interspinous Spacer No Treatment
Hide Arm/Group Description:
FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
Not treated with FLEXUS or X-STOP
Overall Number of Participants Analyzed 62 77 0
Mean (Standard Deviation)
Unit of Measure: millimeters
16.2  (26.72) 9.2  (15.77)
8.Secondary Outcome
Title Mean Visual Analog Scale (VAS) - Left Leg Pain at 24 Months
Hide Description The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with “no pain” on the left border and “as severe as it could be” on the right border. The subject is instructed to make a mark along the line to represent the intensity of left leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to eleven less subjects having VAS data at 24 months in the FLEXUS arm and four less subject with VAS data at 24 months in the X-STOP arm. No data was collected for the "No Treatment" arm.
Arm/Group Title FLEXUS™ Interspinous Spacer XSTOP® Interspinous Spacer No Treatment
Hide Arm/Group Description:
FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
XSTOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
Not treated with FLEXUS or X-STOP
Overall Number of Participants Analyzed 62 77 0
Mean (Standard Deviation)
Unit of Measure: millimeters
13.2  (27.43) 10.7  (20.11)
9.Secondary Outcome
Title Change of Quality of Life
Hide Description Change in mental or physical composite score of the short form SF36
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The short form SF36 was administered to study patients; however, we do not have the proprietary scoring system. Hence the scores could not be calculated.
Arm/Group Title FLEXUS™ Interspinous Spacer X-STOP® Interspinous Spacer No Treatment
Hide Arm/Group Description:
FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
Not treated with FLEXUS or X-STOP
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were reviewed and classified by a Clinical Events Committee (CEC).
 
Arm/Group Title FLEXUS™ Interspinous Spacer X-STOP® Interspinous Spacer No Treatment
Hide Arm/Group Description FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the X-STOP® Spacer Not treated with FLEXUS or X-STOP
All-Cause Mortality
FLEXUS™ Interspinous Spacer X-STOP® Interspinous Spacer No Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/107 (4.67%)   3/106 (2.83%)   0/2 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
FLEXUS™ Interspinous Spacer X-STOP® Interspinous Spacer No Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   41/107 (38.32%)   28/106 (26.42%)   0/2 (0.00%) 
Cardiac disorders       
Cardiovascular  8/107 (7.48%)  5/106 (4.72%)  0/2 (0.00%) 
Gastrointestinal disorders       
Gastrointestinal  2/107 (1.87%)  1/106 (0.94%)  0/2 (0.00%) 
General disorders       
Carpal Tunnel Syndrome  1/107 (0.93%)  0/106 (0.00%)  0/2 (0.00%) 
Death  5/107 (4.67%)  3/106 (2.83%)  0/2 (0.00%) 
Other  1/107 (0.93%)  0/106 (0.00%)  0/2 (0.00%) 
Pseudoarthrosis  1/107 (0.93%)  0/106 (0.00%)  0/2 (0.00%) 
Infections and infestations       
Infection - Superficial Wound  0/107 (0.00%)  1/106 (0.94%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal  1/107 (0.93%)  1/106 (0.94%)  0/2 (0.00%) 
Pain - Back  0/107 (0.00%)  1/106 (0.94%)  0/2 (0.00%) 
Pain - Hip  3/107 (2.80%)  3/106 (2.83%)  0/2 (0.00%) 
Pain - Lower Extremities  1/107 (0.93%)  2/106 (1.89%)  0/2 (0.00%) 
Pain - Neck and/or Upper Extremities  2/107 (1.87%)  2/106 (1.89%)  0/2 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cancer  2/107 (1.87%)  0/106 (0.00%)  0/2 (0.00%) 
Nervous system disorders       
Compressive Peripheral Neuropathy (Non-CTS)  0/107 (0.00%)  1/106 (0.94%)  0/2 (0.00%) 
Renal and urinary disorders       
Urogenital  1/107 (0.93%)  0/106 (0.00%)  0/2 (0.00%) 
Social circumstances       
Trauma  1/107 (0.93%)  0/106 (0.00%)  0/2 (0.00%) 
Surgical and medical procedures       
Surgery - Index Level  21/107 (19.63%)  12/106 (11.32%)  0/2 (0.00%) 
Surgery - Non-Index Lumbar  3/107 (2.80%)  0/106 (0.00%)  0/2 (0.00%) 
Surgery - Non-Index Lumbar  1/107 (0.93%)  0/106 (0.00%)  0/2 (0.00%) 
Vascular disorders       
Cerebrovascular  2/107 (1.87%)  0/106 (0.00%)  0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
FLEXUS™ Interspinous Spacer X-STOP® Interspinous Spacer No Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   77/107 (71.96%)   72/106 (67.92%)   2/2 (100.00%) 
Cardiac disorders       
Cardiovascular  6/107 (5.61%)  3/106 (2.83%)  0/2 (0.00%) 
Gastrointestinal disorders       
Gastrointestinal  2/107 (1.87%)  4/106 (3.77%)  0/2 (0.00%) 
General disorders       
Carpal Tunnel Syndrome (CTS)  0/107 (0.00%)  1/106 (0.94%)  0/2 (0.00%) 
Headache  3/107 (2.80%)  1/106 (0.94%)  0/2 (0.00%) 
Other  10/107 (9.35%)  6/106 (5.66%)  0/2 (0.00%) 
Paresthesia - Lower Extremities  11/107 (10.28%)  10/106 (9.43%)  0/2 (0.00%) 
Paresthesia - Upper Extremities  2/107 (1.87%)  1/106 (0.94%)  0/2 (0.00%) 
Surgery - Index Level  1/107 (0.93%)  0/106 (0.00%)  0/2 (0.00%) 
Weakness  3/107 (2.80%)  3/106 (2.83%)  0/2 (0.00%) 
Infections and infestations       
Infection - Other  6/107 (5.61%)  1/106 (0.94%)  0/2 (0.00%) 
Infection - Superficial Wound  2/107 (1.87%)  5/106 (4.72%)  0/2 (0.00%) 
Injury, poisoning and procedural complications       
Wound Issue  1/107 (0.93%)  3/106 (2.83%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders       
Muscle Spasms  2/107 (1.87%)  2/106 (1.89%)  0/2 (0.00%) 
Musculoskeletal  2/107 (1.87%)  2/106 (1.89%)  0/2 (0.00%) 
Pain - Back  34/107 (31.78%)  32/106 (30.19%)  1/2 (50.00%) 
Pain - Back and Hip  2/107 (1.87%)  2/106 (1.89%)  0/2 (0.00%) 
Pain - Back and Lower Extemities  11/107 (10.28%)  9/106 (8.49%)  0/2 (0.00%) 
Pain - Hip  12/107 (11.21%)  9/106 (8.49%)  0/2 (0.00%) 
Pain - Lower Extremities  26/107 (24.30%)  33/106 (31.13%)  1/2 (50.00%) 
Pain - Lower Extremities with Dysesthesia  4/107 (3.74%)  2/106 (1.89%)  0/2 (0.00%) 
Pain - Neck and/or Upper Extremities  12/107 (11.21%)  8/106 (7.55%)  0/2 (0.00%) 
Pain - Other  2/107 (1.87%)  0/106 (0.00%)  0/2 (0.00%) 
Spinous Process Fracture  4/107 (3.74%)  1/106 (0.94%)  0/2 (0.00%) 
Pain - Back and Lower Extemities with Dysesthesia  0/107 (0.00%)  2/106 (1.89%)  0/2 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cancer  1/107 (0.93%)  1/106 (0.94%)  0/2 (0.00%) 
Nervous system disorders       
Dysesthesia - Lower Extremities  1/107 (0.93%)  2/106 (1.89%)  0/2 (0.00%) 
Neurological  0/107 (0.00%)  4/106 (3.77%)  0/2 (0.00%) 
Psychiatric disorders       
Psychological  2/107 (1.87%)  0/106 (0.00%)  0/2 (0.00%) 
Renal and urinary disorders       
Urogenital  3/107 (2.80%)  2/106 (1.89%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Respiratory  2/107 (1.87%)  1/106 (0.94%)  0/2 (0.00%) 
Social circumstances       
Trauma  6/107 (5.61%)  3/106 (2.83%)  0/2 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Name/Title: Director, Clinical Affairs
Organization: Globus Medical
Phone: 610-930-1800 ext 1669
Responsible Party: Globus Medical Inc
ClinicalTrials.gov Identifier: NCT01156675     History of Changes
Other Study ID Numbers: GPR003
First Submitted: July 1, 2010
First Posted: July 5, 2010
Results First Submitted: December 13, 2017
Results First Posted: April 27, 2018
Last Update Posted: June 1, 2018