Coflex PS3 Actual Conditions for Use Study (PAS003)

Xtant Medical

Status: Enrolling

Conditions: Spinal Stenosis Lumbar

Treatments: Procedure: Decompression; Device: coflex® Interlaminar Technology

Study type: Interventional

Funder types: Industry

Identifiers

NCT02555280

PS3/P110008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

The coflex® Interlaminar Technology

Other group

Description:

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.

Treatment:

Device: coflex® Interlaminar Technology

Decompression

Active Comparator group

Description:

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.

Treatment:

Procedure: Decompression