Coflex PS3 Actual Conditions for Use Study

Not Applicable

Recruiting

• Conditions: Spinal Stenosis Lumbar
• Interventions: Device: coflex® Interlaminar Technology; Procedure: Decompression

• Registration Number: NCT02555280
• Lead Sponsor: Xtant Medical

Brief Summary

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.

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 Timeline

• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-18
• Study First Posted: 2015-09-21
• Study Start: 2019-09-09
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-09
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The coflex® Interlaminar Technology	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.
Decompression	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.

Primary Outcome Measures

Name	Time	Method
coflex performance compared to IDE	24and 60 Months	Evaluation of coflex device performance in conjunction with surgical decompression in an actual conditions of use study.
Composite Clinical Success (CCS)	24 Month	* 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
coflex performance compared to decompression alone from ESCADA study.	24 Months	To compare clinical status of patients implanted with the coflex device in conjunction with surgical decompression relative to surgical decompression alone from ESCADA study.

Secondary Outcome Measures

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

Trial Locations

Locations (19)

Consulting Orthopaedic Associates; 🇺🇸 Toledo, Ohio, United States

Central Cost Neurological Surgery; 🇺🇸 San Luis Obispo, California, United States

St. Joseph's Medical Center; 🇺🇸 Wayne, New Jersey, United States

24_Unity Surgical Center, LLC; 🇺🇸 Lafayette, Indiana, United States

Mercy Regional Medical Center; 🇺🇸 Durango, Colorado, United States

Tallahassee Neurological Clinic; 🇺🇸 Tallahassee, Florida, United States

Spine Institute of Louisiana; 🇺🇸 Shreveport, Louisiana, United States

Northwell Health Physician Partners Orthopaedic Institute at Great Neck; 🇺🇸 Great Neck, New York, United States

Southern Oregon Orthpaedics; 🇺🇸 Medford, Oregon, United States

Hoag Orthopedics; 🇺🇸 Irvine, California, United States

Cervical Disc Center of Los Angeles; 🇺🇸 Santa Monica, California, United States

Orthopaedic Specialist of Northwest Indiana; 🇺🇸 Munster, Indiana, United States

Desert Institute for Spine Care (DISC); 🇺🇸 Phoenix, Arizona, United States

Summit Spine; 🇺🇸 Portland, Oregon, United States

01L_Northshore University Health System; 🇺🇸 Evanston, Illinois, United States

03L_Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States

Sutter Health; 🇺🇸 Sacramento, California, United States

UC Health Spine Center; 🇺🇸 Aurora, Colorado, United States

Austin Neurosurgeons; 🇺🇸 Austin, Texas, United States