Spinal StenosisNCT02457468
The Coflex®COMMUNITY Study: An Observational Study of Coflex® Interlaminar Technology
An observational study of Spinal Stenosis, run by Predicted, Reported and Observed Outcomes Foundation at 28 sites in United States.
Trial summary
The purpose of the coflexCOMMUNITY observational study is to collect information on patients with spinal stenosis undergoing back surgery with the coflex® implant, and to look at their outcomes and the cost-effectiveness of this procedure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- coflex
- Type of treatment
- Medical device
- How many people
- 325 participants
- Where
- 28 sitesUnited States
- Study dates
- Jun 2015to Dec 2019
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cohort will be selected from clinic patients scheduled for surgery with coflex device after decompression
Who may be able to join
- Patient is skeletally mature and has at least moderate impairment in function, experiences relief in flexion from his/her symptoms of leg/buttocks/groin pain, with or without back pain, and has undergone at least 6 months of non-operative treatment;
- Patient is treated surgically at 1 or 2 contiguous lumbar motion segments with the coflex Interlaminar Device from L1-L5 after decompression of stenosis at the affected level(s), where such use is not contraindicated as noted below.
Who cannot join
- Prior fusion or decompressive laminectomy at any index lumbar level;
- Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture);
- Severe facet hypertrophy that requires extensive bone removal which would cause instability;
- Grade II or greater spondylolisthesis;
- Isthmic spondylolisthesis or spondylolysis (pars fracture);
- Degenerative lumbar scoliosis (Cobb angle of greater than 25°);
Show all 15Show fewer
- Osteoporosis;
- Back or leg pain of unknown etiology;
- Axial back pain only, with no leg, buttock, or groin pain;
- Morbid obesity defined as a body mass index > 40;
- Active or chronic infection - systemic or local;
- Known allergy to titanium alloys or magnetic resonance imaging (MRI) contrast agents;
- Cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction;
- Vulnerable population including pregnant women, prisoners, students and employees of treating physicians, and others who can be subject to coercion;
- Patient is unwilling to complete his/her surveys.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Blue Ridge Bone and Joint
Arden, North Carolina, 28704
Brigham and Women's
Boston, Massachusetts, 02115
OrthoTexas
Carrollton, Texas, 75010
Bighorn Medical Center
Cody, Wyoming, 82414
Bassett Medical Center
Cooperstown, New York, 13326
Center for Spine Care
Dallas, Texas, 75287
OrthoNeuro
Dublin, Ohio, 43017
Cantor Spine institute
Fort Lauderdale, Florida, 33306
Southeastern Integrated Medical
Gainesville, Florida, 32607
The Orthopaedic Institute
Gainesville, Florida, 32607
OrthoAtlanta
Lawrenceville, Georgia, 30046
The BACK Center
Melbourne, Florida, 32901
North Jersey Brain and Spine Center
Oradell, New Jersey, 07649
Orthospine Center LTD
Palos Heights, Illinois, 60463
Center for Neurology and Spine
Phoenix, Arizona, 85032
Spine and Orhtopedic Center of New Mexico
Roswell, New Mexico, 88201
The Spine Institute, Center for Spine Restoration
Santa Monica, California, 90403
Arizona Brain and Spine
Scottsdale, Arizona, 85225
NeoSpine
Seattle, Washington, 98372
Orthopedic Center of Illinois
Springfield, Illinois, 62711
New England Orthopedic Surgeons
Springfield, Massachusetts, 01107
The Orthopedic Center of St. Louis
St Louis, Missouri, 63017
Orthopedic Sports Medicine & Spine Care Institute
St Louis, Missouri, 63122
All Florida Orthopaedics
St. Petersburg, Florida, 33703
Consulting Orthopaedic Associates
Sylvania, Ohio, 43560
Laser Spine Institute
Tampa, Florida, 33607
Northwest NeuroSpecialists
Tucson, Arizona, 85741
IGEA Brain and Spine
Union, New Jersey, 07083
About this study
The purpose of the coflexCOMMUNITY observational study is to collect information on patients with spinal stenosis undergoing back surgery with the coflex® implant, and to look at their outcomes and the cost-effectiveness of this procedure.
- Conditions
- Spinal Stenosis
- Being tested
- coflex
- Keywords
- coflex, interlaminar stabilization, lumbar spinal stenosis, neurogenic claudication, decompression
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coflexDevice
| Study group | Role | What they receive |
|---|---|---|
| Stenosis patients treated with coflex | Patients with a primary diagnosis of lumbar spinal stenosis treated with coflex after decompression Receives: Device: coflex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the Oswestry Disability Index (ODI), compared to pre-surgery
The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI). It will be assessed if the improvement in ODI since the pre-surgery status is at least 15 points
Measured: 5 years
Patient has not undergone any reoperations, removals, revisions, or supplemental fixations;
Assessment of reoperations, revisions, removals, or supplemental fixation associated with the coflex device.
Measured: 5 years
Patient has not had any major device related complications
Assessment of major device-related complications, including but not limited to permanent new or increasing sensory or motor deficit at 2 years and 5 years.
Measured: 5 years
Patient has not undergone any Epidural injections
Assessment of lumbar epidural injections
Measured: 5 years
Secondary outcomes (4)
Zurich Claudication Questionnaire (ZCQ)
ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.
Measured: 5 years
Quality of Life
Assessment of the patient's Quality of Life as measured by the Health Outcomes Survey and EQ-5D-5L
Measured: 5 years
VAS Leg Pain
Change in the assessment of leg pain compared to pre-surgery as measured by a Visual Analog Scale (VAS) (on the 100mm scale).
Measured: 5 years
VAS Back Pain
Change in the assessment of back pain compared to pre-surgery as measured by a Visual Analog Scale (VAS) (on the 100mm scale).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 325 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Predicted, Reported and Observed Outcomes Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- SPIRITT Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457468
- Sponsor's protocol ID
- SR-2015-01
- Status last verified
- Feb 2019
- First submitted
- 10 May 2015
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Coflex®COMMUNITY Study: An Observational Study of Coflex® Interlaminar Technology
- ClinicalTrials.gov ID
- NCT02457468
- Acronym / sponsor ID
- SR-2015-01
- Conditions
- Spinal Stenosis
- Keywords
- coflex, interlaminar stabilization, lumbar spinal stenosis, neurogenic claudication, decompression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Predicted, Reported and Observed Outcomes FoundationUniversity, hospital or other
- Collaborators
- SPIRITT Research
- Study start
- Jun 2015
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the coflexCOMMUNITY observational study is to collect information on patients with spinal stenosis undergoing back surgery with the coflex® implant, and to look at their outcomes and the cost-effectiveness of this procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stenosis patients treated with coflex | – | Device: coflexPatients with a primary diagnosis of lumbar spinal stenosis treated with coflex after decompression |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cohort will be selected from clinic patients scheduled for surgery with coflex device after decompression
Key inclusion criteria (2 listed)
- Patient is skeletally mature and has at least moderate impairment in function, experiences relief in flexion from his/her symptoms of leg/buttocks/groin pain, with or without back pain, and has undergone at least 6 months of non-operative treatment;
- Patient is treated surgically at 1 or 2 contiguous lumbar motion segments with the coflex Interlaminar Device from L1-L5 after decompression of stenosis at the affected level(s), where such use is not contraindicated as noted below.
Key exclusion criteria (15 listed)
- Prior fusion or decompressive laminectomy at any index lumbar level;
- Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture);
- Severe facet hypertrophy that requires extensive bone removal which would cause instability;
- Grade II or greater spondylolisthesis;
- Isthmic spondylolisthesis or spondylolysis (pars fracture);
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 |
|---|---|---|
| coflex | Device | Stenosis patients treated with coflex |
Primary outcome
Improvement in the Oswestry Disability Index (ODI), compared to pre-surgery
Time frame: 5 years
The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI). It will be assessed if the improvement in ODI since the pre-surgery status is at least 15 points
Patient has not undergone any reoperations, removals, revisions, or supplemental fixations;
Time frame: 5 years
Assessment of reoperations, revisions, removals, or supplemental fixation associated with the coflex device.
Patient has not had any major device related complications
Time frame: 5 years
Assessment of major device-related complications, including but not limited to permanent new or increasing sensory or motor deficit at 2 years and 5 years.
Patient has not undergone any Epidural injections
Time frame: 5 years
Assessment of lumbar epidural injections
4 secondary outcomes
Zurich Claudication Questionnaire (ZCQ)
Time frame: 5 years
Quality of Life
Time frame: 5 years
VAS Leg Pain
Time frame: 5 years
VAS Back Pain
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
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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.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Stenosis, run by Predicted, Reported and Observed Outcomes Foundation at 28 sites in United States.
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 2 inclusion and 15 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 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in the Oswestry Disability Index (ODI), compared to pre-surgery (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2019.