OSTEOAMP Lumbar Fusion Intra-Patient Controlled Study

NCT05405374 | Unknown

• 1 other identifier: BGS-21-01
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 9

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.

Conditions

Lumbar Spine Disease; Lumbar Spondylolisthesis; Lumbar Spine Instability; Lumbar Spondylosis; Degenerative Disc Disease

Keywords

Lumbar Interbody Fusion

Outcome Measures

Primary Outcomes (1)

• Fusion Status

  Radiographic fusion as defined by the Image Review Charter and assessed by an independent core laboratory.

  12 Months

Secondary Outcomes (1)

• Fusion Status

  24 Months

Other Outcomes (3)

• Functional Impairment

  24 Months

• Back Pain

  24 Months

• Leg Pain

  24 Months

Study Arms (2)

OSTEOAMP

ACTIVE COMPARATOR

OSTEOAMP SELECT Fibers as an autograft substitute in lumbar interbody fusion procedures

Other: OSTEOAMP

Infuse

ACTIVE COMPARATOR

The Infuse Bone Graft as an autograft substitute in lumbar interbody fusion procedures

Device: Infuse

Interventions

OSTEOAMP OTHER

OSTEOAMP SELECT Fibers (derived from human bone allograft) rehydrated with bone marrow aspirate (BMA) and combined with local autogenous graft for use in lumbar interbody fusion of the lumbar spine.

OSTEOAMP

Infuse DEVICE

The Infuse Bone Graft/Medtronic Interbody Fusion Device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2, known as dibotermin alfa) placed on an absorbable collagen sponge (ACS). rhBMP-2 is the active agent in the Infuse Bone Graft component. The ACS is a soft, white, pliable, absorbent implantable matrix for rhBMP-2.

Infuse

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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).
• Any endocrine or metabolic disorder, which in the investigator's opinion, is known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers- Danlos syndrome, or osteogenesis imperfecta).
• History of hypersensitivity and/or allergy to any of the agents used to process OSTEOAMP SELECT, including bacitracin, polymyxin B sulfate, and gentamicin.
• Known hypersensitivity or allergy to any components of the study treatments including, but not limited to bone morphogenetic proteins (BMPs); injectable collagen; protein pharmaceuticals (e.g., monoclonal antibodies or gamma globulins); bovine collagen products; and/or instrumentation materials (e.g., titanium, titanium alloy, cobalt chrome,cobalt chrome alloy, or PEEK).
• Is a prisoner.
• Treatment with an investigational therapy (drug, device, and/or biologic) targeting spinal conditions within 3 months prior to implantation surgery, treatment with any other investigational therapies within 30 days prior to implantation surgery, or such treatment is planned during the 24-month period following implantation of the study treatment.

Sponsors & Collaborators

• Bioventus LLC: lead

Study Sites (9)

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

Kansas Joint and Spine Specialists

Wichita, Kansas, 67226, United States

RECRUITING

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42001, United States

RECRUITING

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

ACTIVE NOT RECRUITING

New England Baptist Hospital

Boston, Massachusetts, 02120, United States

RECRUITING

Tennessee Orthopaedic Alliance

Nashville, Tennessee, 37209, United States

RECRUITING

Austin Neurosurgeons

Austin, Texas, 78746, United States

RECRUITING

OrthoVirginia

Richmond, Virginia, 23235, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

MeSH Terms

Conditions

Spinal Diseases; Spondylolisthesis; Spondylosis; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Spondylolysis

Central Study Contacts

Amanda Doan

CONTACT

(901) 341-2976; amanda.doan@bioventus.com

Adam Waksman, DVM

CONTACT

adam.waksman@bioventus.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In this study, all subjects will be treated at 2 levels of the anterior lumbar spine. One of the levels will be grafted with OSTEOAMP SELECT and the other with Infuse housed within the same type of interbody cage. The assignment of the bone graft product to each treated motion segment will be randomized in a 1:1 ratio. Every subject will serve as his/her own control.

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: June 6, 2022
• Study Start: May 6, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: August 28, 2023

Record last verified: 2023-08

Locations

US (9)