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A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis

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ClinicalTrials.gov Identifier: NCT00401518
Recruitment Status : Completed
First Posted : November 20, 2006
Results First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Globus Medical Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Lumbar Spinal Stenosis
Interventions Device: Non-randomized ACADIA® Facet Replacement System
Device: Randomized ACADIA® Facet Replacement System
Device: Randomized Instrumented posterolateral fusion (PLF)
Enrollment 390
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Non-randomized ACADIA® Randomized ACADIA® Randomized Instrumented PLF
Hide Arm/Group Description Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Period Title: Overall Study
Started 46 227 117
Completed 40 190 94
Not Completed 6 37 23
Arm/Group Title Non-randomized ACADIA® Randomized ACADIA® Randomized Instrumented PLF Total
Hide Arm/Group Description Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis Total of all reporting groups
Overall Number of Baseline Participants 46 227 117 390
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 227 participants 117 participants 390 participants
58.6  (11.46) 61.7  (9.82) 61.4  (10.55) 61.2  (10.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 227 participants 117 participants 390 participants
Female
22
  47.8%
119
  52.4%
55
  47.0%
196
  50.3%
Male
24
  52.2%
108
  47.6%
62
  53.0%
194
  49.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 227 participants 117 participants 390 participants
Asian or Pacific Islander
0
   0.0%
5
   2.2%
0
   0.0%
5
   1.3%
Black or African American
1
   2.2%
2
   0.9%
7
   6.0%
10
   2.6%
Caucasian
41
  89.1%
206
  90.7%
103
  88.0%
350
  89.7%
Hispanic
3
   6.5%
12
   5.3%
7
   6.0%
22
   5.6%
Other
1
   2.2%
2
   0.9%
0
   0.0%
3
   0.8%
Height  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 46 participants 227 participants 117 participants 390 participants
67.3  (3.91) 66.9  (4.41) 67.4  (3.86) 67.1  (4.19)
Weight  
Mean (Standard Deviation)
Unit of measure:  Pounds
Number Analyzed 46 participants 227 participants 117 participants 390 participants
190.8  (41.34) 191.3  (39.62) 191.2  (37.38) 191.2  (39.07)
1.Primary Outcome
Title Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Physical Function Score
Hide Description Physical Function is measured on a scale of 1-4 points (lower values are considered a better outcome)
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-randomized ACADIA® Randomized ACADIA® Randomized Instrumented PLF
Hide Arm/Group Description:
Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Overall Number of Participants Analyzed 40 190 94
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.7  (0.71) 1.6  (0.62) 1.7  (0.73)
2.Primary Outcome
Title Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score
Hide Description Symptom Severity is measured on a scale of 1-5 points (lower values are considered a better outcome)
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
One patient from the Randomized ACADIA group did not have ZCQ Symptom Severity data at 24 months
Arm/Group Title Non-randomized ACADIA® Randomized ACADIA® Randomized Instrumented PLF
Hide Arm/Group Description:
Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Overall Number of Participants Analyzed 40 189 94
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.1  (0.90) 2.0  (0.80) 2.2  (0.98)
3.Primary Outcome
Title Number of Participants Who Maintained or Improved in Neurological Status.
Hide Description Neurological status is based on four types of measurement parameters: muscle strength, straight leg raise, sensory function, and reflexes. Each of the four parameters will be coded as Stable or Improved OR Deteriorated. Neurological assessment scores must be stable or improved compared with the preoperative baseline to be considered "Stable or Improved" neurological status. If these scores have deteriorated as compared to the preoperative baseline, then the neurological status is considered "Deteriorated".
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with Neurological data at 24 months and treated with ACADIA or the control treatment were analyzed
Arm/Group Title Non-randomized ACADIA® Randomized ACADIA® Randomized Instrumented PLF
Hide Arm/Group Description:
Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Overall Number of Participants Analyzed 43 204 99
Measure Type: Count of Participants
Unit of Measure: Participants
30
  69.8%
155
  76.0%
75
  75.8%
4.Secondary Outcome
Title Mean Visual Analog Scale (VAS) Right Leg Pain
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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-randomized ACADIA® Randomized ACADIA® Randomized Instrumented PLF
Hide Arm/Group Description:
Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Overall Number of Participants Analyzed 40 190 94
Mean (Standard Deviation)
Unit of Measure: score on a scale
19.4  (28.11) 13.2  (24.97) 22.5  (30.80)
5.Secondary Outcome
Title Mean Visual Analog Scale (VAS) Left Leg Pain
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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-randomized ACADIA® Randomized ACADIA® Randomized Instrumented PLF
Hide Arm/Group Description:
Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Overall Number of Participants Analyzed 40 190 94
Mean (Standard Deviation)
Unit of Measure: score on a scale
17.5  (29.72) 12.2  (24.25) 16.9  (26.68)
6.Secondary Outcome
Title Mean Visual Analog Scale (VAS) Back Pain
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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-randomized ACADIA® Randomized ACADIA® Randomized Instrumented PLF
Hide Arm/Group Description:
Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Overall Number of Participants Analyzed 40 190 94
Mean (Standard Deviation)
Unit of Measure: score on a scale
24.7  (30.23) 18.8  (25.24) 23.9  (26.86)
7.Secondary Outcome
Title Number of Participants With a Change of at Least 15 Points in Pain/Disability Using the Oswestry Disability Index (ODI) Score at 24 Months Compared With the Score at Baseline
Hide Description The Oswestry Disability Index (ODI) is a commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The 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 possible.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Six Non-randomized ACADIA®, 37 Randomized ACADIA® and 23 Randomized instrumented PLF did not complete the 24 month visit and thus were not analyzed.
Arm/Group Title Non-randomized ACADIA® Randomized ACADIA® Randomized Instrumented PLF
Hide Arm/Group Description:
Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Overall Number of Participants Analyzed 40 190 94
Measure Type: Count of Participants
Unit of Measure: Participants
33
  82.5%
151
  79.5%
62
  66.0%
Time Frame 24 months
Adverse Event Reporting Description The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
 
Arm/Group Title Non-randomized ACADIA® Randomized ACADIA® Randomized Instrumented PLF
Hide Arm/Group Description Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
All-Cause Mortality
Non-randomized ACADIA® Randomized ACADIA® Randomized Instrumented PLF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/46 (4.35%)   4/226 (1.77%)   3/117 (2.56%) 
Hide Serious Adverse Events
Non-randomized ACADIA® Randomized ACADIA® Randomized Instrumented PLF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/46 (43.48%)   111/226 (49.12%)   40/117 (34.19%) 
Cardiac disorders       
Cardiovascular *  3/46 (6.52%)  15/226 (6.64%)  7/117 (5.98%) 
Gastrointestinal disorders       
Gastrointestinal *  3/46 (6.52%)  12/226 (5.31%)  6/117 (5.13%) 
General disorders       
Death *  0/46 (0.00%)  4/226 (1.77%)  0/117 (0.00%) 
Other *  0/46 (0.00%)  5/226 (2.21%)  2/117 (1.71%) 
Trauma *  2/46 (4.35%)  1/226 (0.44%)  3/117 (2.56%) 
Vertebral Fracture *  0/46 (0.00%)  1/226 (0.44%)  0/117 (0.00%) 
Radiographic *  0/46 (0.00%)  1/226 (0.44%)  0/117 (0.00%) 
Immune system disorders       
Metal Allergy *  0/46 (0.00%)  1/226 (0.44%)  0/117 (0.00%) 
Infections and infestations       
Infection - Deep Wound *  0/46 (0.00%)  3/226 (1.33%)  0/117 (0.00%) 
Infection - Other *  2/46 (4.35%)  8/226 (3.54%)  5/117 (4.27%) 
Infection - Superficial Wound *  0/46 (0.00%)  1/226 (0.44%)  0/117 (0.00%) 
Musculoskeletal and connective tissue disorders       
Pain-Neck and/or Upper Extremity *  1/46 (2.17%)  4/226 (1.77%)  3/117 (2.56%) 
Pain - Back *  0/46 (0.00%)  3/226 (1.33%)  1/117 (0.85%) 
Pain-Back and Lower Extremities *  0/46 (0.00%)  2/226 (0.88%)  0/117 (0.00%) 
Pain Lower Extremities *  2/46 (4.35%)  13/226 (5.75%)  8/117 (6.84%) 
Pain - Hip *  1/46 (2.17%)  11/226 (4.87%)  2/117 (1.71%) 
Musculoskeletal *  0/46 (0.00%)  2/226 (0.88%)  0/117 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cancer *  0/46 (0.00%)  5/226 (2.21%)  0/117 (0.00%) 
Nervous system disorders       
Dural Tear *  0/46 (0.00%)  2/226 (0.88%)  1/117 (0.85%) 
Neurological Focal Lumbar *  0/46 (0.00%)  1/226 (0.44%)  0/117 (0.00%) 
Psychiatric disorders       
Psychological *  0/46 (0.00%)  1/226 (0.44%)  0/117 (0.00%) 
Renal and urinary disorders       
Urogenital *  4/46 (8.70%)  5/226 (2.21%)  2/117 (1.71%) 
Respiratory, thoracic and mediastinal disorders       
Respiratory *  0/46 (0.00%)  4/226 (1.77%)  5/117 (4.27%) 
Skin and subcutaneous tissue disorders       
Wound Issue *  0/46 (0.00%)  1/226 (0.44%)  0/117 (0.00%) 
Surgical and medical procedures       
Surgery - Adjacent Level *  1/46 (2.17%)  10/226 (4.42%)  0/117 (0.00%) 
Surgery - Index Level *  7/46 (15.22%)  35/226 (15.49%)  13/117 (11.11%) 
Surgery - Other (Non-Lumbar) *  1/46 (2.17%)  1/226 (0.44%)  0/117 (0.00%) 
Surgery - Other Lumbar *  1/46 (2.17%)  0/226 (0.00%)  1/117 (0.85%) 
Vascular disorders       
Cerebrovascular *  0/46 (0.00%)  5/226 (2.21%)  1/117 (0.85%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Non-randomized ACADIA® Randomized ACADIA® Randomized Instrumented PLF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   46/46 (100.00%)   213/226 (94.25%)   108/117 (92.31%) 
Cardiac disorders       
Cardiovascular *  10/46 (21.74%)  21/226 (9.29%)  13/117 (11.11%) 
Gastrointestinal disorders       
Gastrointestinal *  9/46 (19.57%)  32/226 (14.16%)  9/117 (7.69%) 
General disorders       
Headache *  1/46 (2.17%)  3/226 (1.33%)  0/117 (0.00%) 
Other *  20/46 (43.48%)  42/226 (18.58%)  24/117 (20.51%) 
Pain - Other *  0/46 (0.00%)  5/226 (2.21%)  2/117 (1.71%) 
Trauma *  11/46 (23.91%)  42/226 (18.58%)  26/117 (22.22%) 
Spinous Process Fracture *  0/46 (0.00%)  1/226 (0.44%)  0/117 (0.00%) 
Vertebral Fracture *  0/46 (0.00%)  2/226 (0.88%)  1/117 (0.85%) 
Weakness *  0/46 (0.00%)  2/226 (0.88%)  4/117 (3.42%) 
Dural Tear *  2/46 (4.35%)  22/226 (9.73%)  12/117 (10.26%) 
Radiographic *  1/46 (2.17%)  5/226 (2.21%)  0/117 (0.00%) 
Hepatobiliary disorders       
Pseudoarthrosis *  0/46 (0.00%)  0/226 (0.00%)  2/117 (1.71%) 
Immune system disorders       
Metal Allergy *  0/46 (0.00%)  1/226 (0.44%)  0/117 (0.00%) 
Infections and infestations       
Infection - Superficial Wound *  1/46 (2.17%)  4/226 (1.77%)  2/117 (1.71%) 
Infection - Other *  9/46 (19.57%)  23/226 (10.18%)  17/117 (14.53%) 
Musculoskeletal and connective tissue disorders       
Muscle Spasms *  0/46 (0.00%)  4/226 (1.77%)  1/117 (0.85%) 
Pain-Neck and/or Upper Extremity *  9/46 (19.57%)  30/226 (13.27%)  22/117 (18.80%) 
Pain - Back *  19/46 (41.30%)  72/226 (31.86%)  27/117 (23.08%) 
Pain-Back and Lower Extremities *  6/46 (13.04%)  34/226 (15.04%)  17/117 (14.53%) 
Pain - Back and Hip *  0/46 (0.00%)  3/226 (1.33%)  1/117 (0.85%) 
Pain Lower Extremities *  18/46 (39.13%)  68/226 (30.09%)  38/117 (32.48%) 
Pain - Hip *  12/46 (26.09%)  28/226 (12.39%)  14/117 (11.97%) 
Musculoskeletal *  5/46 (10.87%)  18/226 (7.96%)  13/117 (11.11%) 
Pain-Back and Lower Extremities with Dysesthesia *  2/46 (4.35%)  10/226 (4.42%)  2/117 (1.71%) 
Pain-Back with Dysesthesia *  0/46 (0.00%)  2/226 (0.88%)  1/117 (0.85%) 
Pain Lower Extremities with Dysesthesia *  3/46 (6.52%)  8/226 (3.54%)  5/117 (4.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cancer *  2/46 (4.35%)  2/226 (0.88%)  4/117 (3.42%) 
Nervous system disorders       
Dysesthesia - Upper Extremities *  1/46 (2.17%)  0/226 (0.00%)  1/117 (0.85%) 
Dysesthesia - Lower Extremities *  2/46 (4.35%)  2/226 (0.88%)  2/117 (1.71%) 
Neurological Systemic *  1/46 (2.17%)  4/226 (1.77%)  1/117 (0.85%) 
Dysesthesia - Other *  0/46 (0.00%)  3/226 (1.33%)  1/117 (0.85%) 
Paresthesia - Upper Extremities *  4/46 (8.70%)  7/226 (3.10%)  4/117 (3.42%) 
Paresthesia - Lower Extremities *  4/46 (8.70%)  22/226 (9.73%)  10/117 (8.55%) 
Paresthesia - Other *  1/46 (2.17%)  0/226 (0.00%)  0/117 (0.00%) 
Neurological Focal Lumbar *  21/46 (45.65%)  104/226 (46.02%)  50/117 (42.74%) 
Neurolgical Focal Other *  3/46 (6.52%)  10/226 (4.42%)  3/117 (2.56%) 
Peripheral Neuropathy *  1/46 (2.17%)  5/226 (2.21%)  1/117 (0.85%) 
Psychiatric disorders       
Psychological *  0/46 (0.00%)  8/226 (3.54%)  1/117 (0.85%) 
Renal and urinary disorders       
Urogenital *  2/46 (4.35%)  21/226 (9.29%)  5/117 (4.27%) 
Respiratory, thoracic and mediastinal disorders       
Respiratory *  2/46 (4.35%)  16/226 (7.08%)  7/117 (5.98%) 
Skin and subcutaneous tissue disorders       
Wound Issue *  1/46 (2.17%)  5/226 (2.21%)  4/117 (3.42%) 
Surgical and medical procedures       
Surgery - Adjacent Level *  0/46 (0.00%)  3/226 (1.33%)  2/117 (1.71%) 
Surgery-Index Level *  2/46 (4.35%)  6/226 (2.65%)  1/117 (0.85%) 
Surgery - Other (Non-Lumbar) *  1/46 (2.17%)  2/226 (0.88%)  0/117 (0.00%) 
Surgery - Other Lumbar *  0/46 (0.00%)  1/226 (0.44%)  0/117 (0.00%) 
Vascular disorders       
Cerebrovascular *  1/46 (2.17%)  3/226 (1.33%)  0/117 (0.00%) 
*
Indicates events were collected by non-systematic assessment
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.
To prevent premature disclosure of trade secrets or other confidential information, Investigator agrees not to present, publish, or disclose study results or information about the investigational device without the express written consent of the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Affairs
Organization: Globus Medical
Phone: 610-930-1800
EMail: jmyer@globusmedical.com
Layout table for additonal information
Responsible Party: Globus Medical Inc
ClinicalTrials.gov Identifier: NCT00401518    
Other Study ID Numbers: 1020-9052
First Submitted: November 17, 2006
First Posted: November 20, 2006
Results First Submitted: August 10, 2020
Results First Posted: September 10, 2020
Last Update Posted: September 10, 2020