The Coflex®COMMUNITY Study: An Observational Study of Coflex® Interlaminar Technology

Predicted, Reported and Observed Outcomes Foundation

Status: Completed

Conditions: Spinal Stenosis

Treatments: Device: coflex

Study type: Observational

Funder types: Other

Identifiers

NCT02457468

SR-2015-01

Details and patient eligibility

About

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.

Enrollment: 325 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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;
2. 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.

Exclusion criteria

1. Prior fusion or decompressive laminectomy at any 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. Grade II or greater spondylolisthesis;
5. Isthmic spondylolisthesis or spondylolysis (pars fracture);
6. Degenerative lumbar scoliosis (Cobb angle of greater than 25°);
7. Osteoporosis;
8. Back or leg pain of unknown etiology;
9. Axial back pain only, with no leg, buttock, or groin pain;
10. Morbid obesity defined as a body mass index > 40;
11. Active or chronic infection - systemic or local;
12. Known allergy to titanium alloys or magnetic resonance imaging (MRI) contrast agents;
13. Cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction;
14. Vulnerable population including pregnant women, prisoners, students and employees of treating physicians, and others who can be subject to coercion;
15. Patient is unwilling to complete his/her surveys.

Trial design

325 participants in 1 patient group

Stenosis patients treated with coflex

Description:

Patients with a primary diagnosis of lumbar spinal stenosis treated with coflex after decompression

Treatment:

Device: coflex