OSTEOAMP Lumbar Fusion Intra-Patient Controlled Study
United States101 participantsStarted 2022-05-06
Plain-language 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.
Who can participate
Age range21 Years – 80 Years
SexALL
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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/m2.
* Documented history of uncontrolled diabetes mellitus
* Presence of active malignancy or prior history of malignancy (non-invasive basal cell c…