A Prospective, Randomized, Intra-Patient Controlled, Multi-Center Clinical Investigation Evaluating OSTEOAMP SELECT Fibers Versus Infuse Bone Graft as Autograft Substitute in Lumbar Fusion Procedures
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Bioventus LLC
- Enrollment
- 101
- Locations
- 9
- Primary Endpoint
- Fusion Status
Overview
Brief Summary
The objective of this clinical study is to compare OSTEOAMP SELECT Fibers to Infuse Bone Graft, in terms of effectiveness and safety, when used as a bone graft substitute in in skeletally mature patients qualified for 2-lumbar interbody fusion (LIF) by means of an intra-patient control model.
Detailed Description
The current study will collect clinical evidence for OSTEOAMP SELECT in spinal fusion procedures. In particular, the study will explore the use of OSTEOAMP SELECT as part of a lumbar interbody fusion (LIF) procedure of two lumbar motion segments between L2 to S1 in patients suffering from symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or mild degenerative scoliosis.
Effectiveness will be based on the lumbar interbody fusion rate at the index levels assessed by a treatment-blinded independent reviewer at 12 months and 24 months.
Safety will be evaluated by documenting the number and nature of all (serious) adverse events that may in any way be related to the surgical procedure or product. The complication rate will be compared to the rate in control populations from literature.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Skeletally mature male or female patient, at least 21 years of age and no more than 80 years of age, inclusive, at the time of surgery;
- •Has symptomatic degenerative disc disease (DDD) of the lumbosacral spine in two levels (L2 to S1). Lumbar DDD is defined as discogenic back pain with or without radicular symptoms confirmed by patient history and radiographic studies
- •Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative lumbosacral disease including instability up to and including Grade 1 spondylolisthesis at the involved level(s)
- •Requires fusion (i.e., symptomatic) at 2 adjacent or non-adjacent levels from L2 to S1;
- •Non-responsive to non-operative treatment (e.g., bed rest, physical therapy, medication,spinal injection, manipulation, and/or TENS) for at least 6 months;
- •Willing and able to comply with the study protocol (including post-operative clinical and radiographic evaluations and required rehabilitation plan) and able to understand and sign the Informed Consent.
Exclusion Criteria
- •Previous lumbar spine surgery with the exception of discectomy and/or laminectomy at the target levels.
- •Lumbar scoliosis \>30 degrees.
- •Documented history of osteoporosis, osteomalacia, Paget's disease or metabolic bone disease
- •Morbidly obese, as defined by a Body Mass Index (BMI) \>40 kg/m
- •Documented history of uncontrolled diabetes mellitus
- •Presence of active malignancy or prior history of malignancy (non-invasive basal cell carcinoma of the skin is allowed).
- •Overt or active bacterial infection, either local to surgical space or systemic.
- •Chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)
- •Co-morbidities, which in the investigator's opinion, precludes the subject from being a surgical candidate.
- •Autoimmune disease, which in the investigator's opinion, is known to affect bone metabolism or the spine (e.g., spondyloarthropathies, juvenile arthritis, rheumatoid arthritis, Graves' disease, Hashimoto's thyroiditis).
Outcomes
Primary Outcomes
Fusion Status
Time Frame: 12 Months
Radiographic fusion as defined by the Image Review Charter and assessed by an independent core laboratory.
Secondary Outcomes
- Fusion Status(24 Months)