P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation

Cerapedics

Status: Active, not recruiting

Conditions: Degenerative Disc Disease

Treatments: Device: P-15L Bone Graft; Other: Local autologous bone in a TLIF with Instrumentation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03438747

CP-1006

Details and patient eligibility

About

The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied in instrumented transforaminal lumbar interbody fusion (TLIF) in subjects with degenerative disc disease (DDD). In addition to the general overall objective, a sub-group analysis will be performed on the high-risk subject population (tobacco use, obesity, diabetes), as previous studies have shown negative effects of smoking, obesity and diabetes on fusion and bone healing, increased peri/postoperative complications, and lower patient-reported outcome scores.

Enrollment: 290 patients

Sex: All

Ages: 22 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (abbreviated):

Skeletally mature adults between 22 and 80 years old (inclusive);

Back pain with radicular symptoms as evidenced by leg pain, confirmed by history and physical exam;

Oswestry Low Back Pain Disability Questionnaire score of ≥ 35;

Involved disc(s) between L2 and S1;

Exclusion Criteria (abbreviated):

Significant metabolic disease that in the surgeon's opinion might compromise bone growth such as osteoporosis, osteopenia, or osteomalacia;

Active malignancy;

Nondiscogenic source of symptoms (e.g. tumor, etc.);

Multiple level symptomatic degenerative disc disease where more than one level requires fusion;

Previous spinal instrumentation or a previous interbody fusion procedure at the involved level;

More than one level to be fused

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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290 participants in 2 patient groups

P-15L Bone Graft

Experimental group

Description:

The investigational group will be treated with P-15L Bone Graft in an instrumented TLIF

Treatment:

Device: P-15L Bone Graft

Local autologous bone

Active Comparator group

Description:

The active control group will be treated with local autologous bone in an instrumented TLIF

Treatment:

Other: Local autologous bone in a TLIF with Instrumentation