Lumbar Spinal StenosisNCT00401518

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

A study testing Non-randomized ACADIA® Facet Replacement System, Randomized ACADIA® Facet Replacement System and Randomized Instrumented posterolateral fusion (PLF) in people with Lumbar Spinal Stenosis, run by Globus Medical Inc at 29 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine if the ACADIA® Facet Replacement System is effective in the treatment of spinal stenosis. The primary objective of the study is to evaluate the overall success rate of the Anatomic Facet Replacement System in patients with spinal stenosis when compared to a posterior spinal… Read more about this study

Who is it for?: Ages 21 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Lumbar Spinal Stenosis
What is being tested?: Non-randomized ACADIA® Facet Replacement System, Randomized ACADIA® Facet Replacement System and Randomized Instrumented posterolateral fusion (PLF)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 390 participants
Where: 29 sitesin 2 countries
Study dates: Oct 2006to Oct 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

21-85 years of age and skeletally mature;
Have undergone 6 months of non-operative treatment prior to surgery;
Lateral, lateral recess and/or central canal stenosis;
Disc height measuring ≥ 4 mm at the operative level;
Persistent leg, thigh and/or buttock symptoms,including pain,numbness, burning or tingling with a minimum leg pain score of 40mm as measured with the Visual Analogue Scale (VAS) Index;
A score greater than 2 on a scale of 1-5 on the Zurich Claudication Questionnaire (ZCQ) Symptom Severity (SS) Score-Candidate;

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A score greater than or equal to 2 on a scale of 1-4 on the ZCQ Physical Function (PF) Score;
A candidate for a decompression with full facetectomy at the operative level
Candidate for a posterior lumbar fusion;
Physically and mentally willing and able to comply evaluations;
Lives in the immediate area and has no plans to relocate;

Who cannot join

Previous surgical procedure at the operative or adjacent level except for one of the following: Micro-discectomy, laminectomy, lamino/foraminotomy, rhizotomy, IDET, and/or interspinous spacer;
Previous lumbar fusion or disc replacement procedure;
Osteoporosis;
greater than Grade I spondylolisthesis or retrolisthesis;
Spondylolisthesis at levels other than at the operative level;
Scoliosis of the lumbar spine (defined as more than 11 deg Cobb angle) as indicated by plain X-ray films;

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Primary diagnosis of discogenic back pain due to torn, herniated, inflamed or irritated disc or other pathology where the patient exhibits axial back pain from degenerative disc disease;
Acute traumatic pars fracture at the operative/adjacent level vertebral body;
Spinal stenosis at more than three lumbar segments;
Acute trauma to the lumbar spine within the last 24 months;
Active infection at the operative level, or a systemic infection;
Physically / mentally compromised;
Systemic disease that would affect the patient's welfare or the research study.
Immunologically suppressed or immunocompromised;
Insulin-Dependent Diabetes Mellitus (Type I Diabetes);
Currently undergoing long-term steroid therapy;
Metabolic bone disease;
Active malignancy: (except non-melanoma skin cancer), unless treated with no clinical signs or symptoms of the malignancy for at least 5 years;
Known allergy to cobalt chromium or titanium;
Used any investigational drug or device within the past 30 days;
Pending litigation related to back pain or injury;
Is a prisoner.

Trial locations and contacts

29 sites in 2 countries.

Country

City, postcode or hospital

29 sites in 2 countries

United States28 sites

Abington Memorial Hospital
Abington, Pennsylvania, 19001
Albany Medical Center
Albany, New York, 12208
Central Texas Spine Institute
Austin, Texas, 78731
Spine Group Beverly Hills
Beverly Hills, California, 90211
Boulder Neurosurgical & Spine Associates
Boulder, Colorado, 80303
Neuro-Spine Solutions
Bristol, Tennessee, 37620
Indiana Spine Group
Carmel, Indiana, 46032
Charleston Brain & Spine
Charleston, South Carolina, 29406
Medical University of South Carolina
Charleston, South Carolina, 29425
Carolina Neurosurgery and Spine Associates, P.C.
Charlotte, North Carolina, 28204
OrthoCarolina Spine Center
Charlotte, North Carolina, 28207
The Center for Sports Medicine & Orthopedics
Chattanooga, Tennessee, 37404
Riverhills Healthcare
Cincinnati, Ohio, 45242
Florida Spine Institute
Clearwater, Florida, 33765
Spine Colorado
Durango, Colorado, 81301
Fort Wayne Orthopaedics
Fort Wayne, Indiana, 46804
Spine Midwest, Inc.
Jefferson City, Missouri, 65101
Cedars-Sinai Spine Center
Los Angeles, California, 90048
Rocky Mountain Associates (RMA) in Orthopedic Medicine
Loveland, Colorado, 80538
Rubin Institute for Advanced Orthopaedics
Owings Mills, Maryland, 21117
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Desert Orthopaedic Center
Rancho Mirage, California, 92270
University of Utah
Salt Lake City, Utah, 84108
Neurological Institute of Savannah and Center for Spine
Savannah, Georgia, 31405
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
Springfield Neurological & Spine Institute
Springfield, Missouri, 65804
Foundation for Orthopaedic Research and Education
Tampa, Florida, 33637
UMASS Memorial Medical Center
Worcester, Massachusetts, 01605

Other trials in United States

Puerto Rico1 site

University of Puerto Rico
San Juan, 00921

Other trials in Puerto Rico

About this study

Official title: The Investigational Plan for the Evaluation of the ACADIA® Facet Replacement System

Read the detailed description

Spinal Stenosis continues to be a major cause of back and leg pain. The condition is attributed to narrowing of the space around the nerves in the lumbar spine. This is often caused by the degenerative process in the spine and the facet joints. The current treatment calls for removal of bone around the affected nerve including the facet joints and fusing the posterior of the spine to ensure the segments remain stable.

The ACADIA® Facet Replacement System (AFRS) allows for an anatomic reconstruction of the facet joint after decompression and removal of the degenerated facet. Like the original facet joint, the replacement implant is designed to reproduce facet motion while restoring normal stability and motion.

The ACADIA® Facet Replacement System (AFRS) has been designed on the principals that have allowed other total joint replacement procedures to provide significant patient benefits. These guiding principals include:

Anatomically based implant design
Reproducible surgical technique
Elimination of pain

The ACADIA® Facet Replacement System allows the surgeon to remove the offending bone while preserving the motion of the facet joint.

This study will evaluate the outcomes of patients using the AFRS™ investigation compared to those receiving instrumented posterior fusion procedure. Patients will be required to complete study visits before the procedure and at 6 weeks, 3, 6, 12, 24 months post procedure and annually thereafter as required by FDA. Follow up visits consist of administration of questionnaires, radiographs and neurological assessment.

Conditions: Lumbar Spinal Stenosis
Being tested: Non-randomized ACADIA® Facet Replacement System, Randomized ACADIA® Facet Replacement System, Randomized Instrumented posterolateral fusion (PLF)
Keywords: Spinal Stenosis, Lumbar Spinal Stenosis, Facet Arthroplasty, Posterior Fusion, Facet Arthritis
Medical subject headings: Spinal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Non-randomized ACADIA® Facet Replacement SystemDevice
Non-randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis
Randomized ACADIA® Facet Replacement SystemDevice
Randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis
Randomized Instrumented posterolateral fusion (PLF)Device
Randomized control treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis

Study groups in NCT00401518
Study group	Role	What they receive
ACADIA®	Experimental	Investigational surgical treatment using the ACADIA Facet Replacement system Receives: Device: Non-randomized ACADIA® Facet Replacement System; Device: Randomized ACADIA® Facet Replacement System
Control Instrumented PLF	Active comparator	Control surgical treatment using an instrumented posterolateral fusion Receives: Device: Randomized Instrumented posterolateral fusion (PLF)

What is being measured

The primary outcome is the main question the study is designed to answer.

Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Physical Function Score
Physical Function is measured on a scale of 1-4 points (lower values are considered a better outcome)
Measured: 24 months
Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score
Symptom Severity is measured on a scale of 1-5 points (lower values are considered a better outcome)
Measured: 24 months
Number of Participants Who Maintained or Improved in Neurological Status.
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".
Measured: 24 months

Secondary outcomes (4)

Mean Visual Analog Scale (VAS) Right Leg Pain
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.
Measured: 24 months
Mean Visual Analog Scale (VAS) Left Leg Pain
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.
Measured: 24 months
Mean Visual Analog Scale (VAS) Back Pain
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.
Measured: 24 months
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
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.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2006Oct 2017

First posted20 Nov 2006 (estimated)
Study startOct 2006
Primary completionAug 2017
Study completionOct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 390 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00401518
Sponsor's protocol ID: 1020-9052
Status last verified: Aug 2020
First submitted: 17 Nov 2006
Last updated: 10 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
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Thoracic-Lumbar Arthrodesis- Implanet Jazz
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All Lumbar Spinal Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Investigational Plan for the Evaluation of the ACADIA® Facet Replacement System
ClinicalTrials.gov ID: NCT00401518
Acronym / sponsor ID: 1020-9052
Conditions: Lumbar Spinal Stenosis
Keywords: Spinal Stenosis, Lumbar Spinal Stenosis, Facet Arthroplasty, Posterior Fusion, Facet Arthritis
Study type: Interventional
Recruitment status: Completed
Enrolment: 390 participants (actual)
Lead sponsor: Globus Medical IncIndustry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: Aug 2017 (actual)
Study completion: Oct 2017 (actual)
First posted: 20 Nov 2006 (estimated)
Results: Posted 10 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Anatomically based implant design
Reproducible surgical technique
Elimination of pain

The ACADIA® Facet Replacement System allows the surgeon to remove the offending bone while preserving the motion of the facet joint.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ACADIA®	Experimental	Device: Non-randomized ACADIA® Facet Replacement System, Device: Randomized ACADIA® Facet Replacement SystemInvestigational surgical treatment using the ACADIA Facet Replacement system
Control Instrumented PLF	Active comparator	Device: Randomized Instrumented posterolateral fusion (PLF)Control surgical treatment using an instrumented posterolateral fusion

Who may qualify

Ages: 21 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

21-85 years of age and skeletally mature;
Have undergone 6 months of non-operative treatment prior to surgery;
Lateral, lateral recess and/or central canal stenosis;
Disc height measuring ≥ 4 mm at the operative level;
Persistent leg, thigh and/or buttock symptoms,including pain,numbness, burning or tingling with a minimum leg pain score of 40mm as measured with the Visual Analogue Scale (VAS) Index;

Key exclusion criteria (22 listed)

Previous surgical procedure at the operative or adjacent level except for one of the following: Micro-discectomy, laminectomy, lamino/foraminotomy, rhizotomy, IDET, and/or interspinous spacer;
Previous lumbar fusion or disc replacement procedure;
Osteoporosis;
greater than Grade I spondylolisthesis or retrolisthesis;
Spondylolisthesis at levels other than at the operative level;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Non-randomized ACADIA® Facet Replacement SystemNon-randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis	Device	ACADIA®
Randomized ACADIA® Facet Replacement SystemRandomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis	Device	ACADIA®
Randomized Instrumented posterolateral fusion (PLF)Randomized control treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis	Device	Control Instrumented PLF

Primary outcome

Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Physical Function Score
Time frame: 24 months
Physical Function is measured on a scale of 1-4 points (lower values are considered a better outcome)
Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score
Time frame: 24 months
Symptom Severity is measured on a scale of 1-5 points (lower values are considered a better outcome)
Number of Participants Who Maintained or Improved in Neurological Status.
Time frame: 24 months
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".

4 secondary outcomes

Mean Visual Analog Scale (VAS) Right Leg Pain
Time frame: 24 months
Mean Visual Analog Scale (VAS) Left Leg Pain
Time frame: 24 months
Mean Visual Analog Scale (VAS) Back Pain
Time frame: 24 months
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
Time frame: 24 months

Results and safety

Results posted to the registry on 10 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non-randomized ACADIA®	46	40
Randomized ACADIA®	227	190
Randomized Instrumented PLF	117	94

Primary outcome: Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Physical Function Score

Time frame: 24 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Non-randomized ACADIA® n = 40	Randomized ACADIA® n = 190	Randomized Instrumented PLF n = 94
Value	1.7 (0.71)	1.6 (0.62)	1.7 (0.73)

Primary outcome: Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score

Time frame: 24 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Non-randomized ACADIA® n = 40	Randomized ACADIA® n = 189	Randomized Instrumented PLF n = 94
Value	2.1 (0.90)	2.0 (0.80)	2.2 (0.98)

Population analysed: One patient from the Randomized ACADIA group did not have ZCQ Symptom Severity data at 24 months

Primary outcome: Number of Participants Who Maintained or Improved in Neurological Status.

Time frame: 24 months. Count of participants. Unit: Participants

Measure	Non-randomized ACADIA® n = 43	Randomized ACADIA® n = 204	Randomized Instrumented PLF n = 99
Value	30	155	75

Population analysed: Only patients with Neurological data at 24 months and treated with ACADIA or the control treatment were analyzed

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non-randomized ACADIA®	20 of 46 (43.5%)	46 of 46 (100%)	2 of 46
Randomized ACADIA®	111 of 226 (49.1%)	213 of 226 (94.2%)	4 of 226
Randomized Instrumented PLF	40 of 117 (34.2%)	108 of 117 (92.3%)	3 of 117

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lumbar Spinal Stenosis

Not yet recruitingObservational study
Foraminal Imaging and Symptoms in Single-Level Degenerative Lumbar Stenosis
Degenerative Lumbar Spinal Stenosis, Lumbar Foraminal Stenosis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

29 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Physical Function Score (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00401518.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.