Coflex PS3 Actual Conditions for Use Study (PAS003)

A 2 and 5 Year Evaluation of Clinical Outcomes in the Treatment of Degenerative Spinal Stenosis With Concomitant Low Back Pain by Decompression With Additional Stabilization Using the Coflex® Interlaminar Technology for FDA Actual Conditions for Use Study.

A 2 and 5 year evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with additional stabilization using the coflex® Interlaminar Technology for FDA Actual Conditions of Use Study.

Study Overview

• Status: Completed
• Conditions: Spinal Stenosis Lumbar
• Intervention / Treatment: Device: coflex® Interlaminar Technology; Procedure: Decompression

Detailed Description

A prospective, multi center, concurrently enrolled, propensity score controlled through Month 60. The purpose is to fully characterize safety and efficacy then the coflex device is used in the intended subject population under actual conditions of use.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Desert Institute for Spine Care (DISC)
  • California
    • Sacramento, California, United States, 95816
      • Sutter Health
    • San Luis Obispo, California, United States, 93401
      • Central Cost Neurological Surgery
    • Santa Monica, California, United States, 90404
      • Cervical Disc Center of Los Angeles
  • Colorado
    • Aurora, Colorado, United States, 80045
      • UC Health Spine Center
  • Florida
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Neurological Clinic
  • Illinois
    • Evanston, Illinois, United States, 60201
      • 01L_Northshore University Health System
  • Indiana
    • Lafayette, Indiana, United States, 47905
      • 24_Unity Surgical Center, LLC
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Spine Institute of Louisiana
  • New York
    • Great Neck, New York, United States, 11021
      • Northwell Health Physician Partners Orthopaedic Institute at Great Neck
  • Oregon
    • Medford, Oregon, United States, 97504
      • Southern Oregon Orthpaedics
    • Portland, Oregon, United States, 97225
      • Summit Spine
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • 03L_Thomas Jefferson University
  • Texas
    • Austin, Texas, United States, 78746
      • Austin Neurosurgeons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Radiographic confirmation of at least moderate lumbar stenosis at one or two contiguous levels from L1-L5 that require surgical decompression.
2. Visual Analog Scale back pain score of at least 50 mm on a 100 mm scale.
3. Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair.
4. Subject has undergone at least one lumbar injection at any prior time point, AND/OR at least 6 months of prior conservative care without adequate and sustained symptom relief.
5. Skeletally mature
6. Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%).
7. Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.
8. Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

1. Prior fusion or decompressive laminectomy at index lumbar level.
2. Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture).
3. Severe facet hypertrophy that requires extensive bone removal which would cause instability.
4. Isthmic spondylolisthesis or spondylolysis (pars fracture).
5. Degenerative lumbar scoliosis (Cobb angle of greater than 25°).
6. Osteoporsis or is at increased risk of osteoporosis.
7. Back or leg pain of unknown etiology.
8. Axial back pain only, with no leg, buttock, or groin pain.
9. Morbid obesity defined as a body mass index > 40.
10. Known allergy to titanium, titanium alloys, or MR contrast agents.
11. Active or chronic infection - systemic or local.
12. Cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: The coflex® Interlaminar Technology; The coflex device was designed to address the clinical needs of spinal stenosis patients by providing stabilization of the affected level without fusion. The coflex is an interspinous process functional dynamic implant designed to impart a stabilizing effect at the treated level(s). The coflex device was approved by FDA in 2012.	Device: coflex® Interlaminar Technology; Decompression plus coflex® Interlaminar Technology; Other Names: coflex
Active Comparator: Decompression; Lumbar decompression back surgery is when a small portion of the bone over the nerve root and/or disc material from under the nerve root is removed to give the nerve root more space and provide a better healing environment.	Procedure: Decompression; Decompression alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
coflex performance compared to IDE	Evaluation of coflex device performance in conjunction with surgical decompression in an actual conditions of use study.	24and 60 Months
coflex performance compared to decompression alone from ESCADA study.	To compare clinical status of patients implanted with the coflex device in conjunction with surgical decompression relative to surgical decompression alone from ESCADA study.	24 Months
Composite Clinical Success (CCS)	No secondary surgical interventions; No lumbar epidural injection, nerve block procedures at index level to treat spinal stenosis at any lumbar level; 15 point improvement in ODI in subjects with no interventions or injections; No new or increasing sensor or motor deficit; No major device related adverse events	24 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Oswestry Disability Index (ODI)	Quality of life as determined by ODI. In terms of achieving at least a 15 point improvement.	Baseline, 24 and 60 months
Change in Visual Analog Scale (VAS) for low back pain	Low back pain reduction evaluated by use of VAS for back pain. In terms of achieving at least a 20 point improvement.	Baseline, 24 and 60 Months
Change in Visual Analog Scale (VAS) for leg pain	Leg pain reduction evaluated by use of VAS for leg pain. In terms of achieving at least a 20 point improvement.	Baseline, 24 and 60 Months
Neurological Status	Assessment of maintenance of improvement after surgery.	Baseline, 6 weeks, 12, 24, 36, 48, 60 Months
Radiographic Assessments	Significant migration or complete expulsion of implant; Spinous process fracture; Maintenance of foraminal height; adjacent level disease	6 weeks, 12, 24, 60 Months
Modified CCS	CCS will be modified to include no use of a narcotic (opioids or opiates).	24 Month
Medication Usage	No use of narcotic (opioids and/or opiates)	24 Month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Evaluation	Safety will be evaluated by assessing the incidence of device and/or procedure related adverse events, revision, additional stabilizations	Procedure, 6 week, 12, 24, 36, 48, 60 Months

Collaborators and Investigators

• Sponsor: Companion Spine, LLC
• Collaborators: MCRA

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): May 31, 2026
• Study Completion (Actual): May 31, 2026

Study Registration Dates

• First Submitted: September 2, 2015
• First Submitted That Met QC Criteria: September 18, 2015
• First Posted (Estimated): September 21, 2015

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: low back pain; decompression; spinal stenosis; neurogenic claudication; moderate lumbar stenosis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Spinal Stenosis; Low Back Pain; Therapeutics; Mechanical Phenomena; Physical Phenomena; Pressure; Decompression
• Other Study ID Numbers: PS3/P110008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes