Recruiting

OSTEOAMP

Sponsor:

Bioventus LLC

Code:

NCT05405374

Conditions

Lumbar Spine Disease

Lumbar Spondylolisthesis

Lumbar Spine Instability

Lumbar Spondylosis

Degenerative Disc Disease

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

OSTEOAMP

Infuse

Study Details

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

Study ID

NCT05405374

Start date

May 6, 2022

Status verified date

Aug, 2023

Completion date

Oct, 2025

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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 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.
  • Pregnant or nursing. Females of child-bearing potential must agree not to become pregnant for the duration of the study.
  • A history of alcohol and/or drug abuse within 6 months prior to screening or exhibits evidence, in the investigator's opinion, of alcohol/drug abuse at screening.
  • Current history of heavy nicotine use (e.g. more than 20 cigarettes per day).
  • Any condition, which in the investigator's opinion, would interfere with the subject's ability to comply with study instructions, which might confound data interpretation.

Study Design

Enrollment

101 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: OSTEOAMP

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

active comparator: Infuse

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

Interventions

OSTEOAMP

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.

Infuse

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.

Primary outcome measure

  • Fusion Status [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Amanda Doan

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

Adam Waksman, DVM

adam.waksman@bioventus.com

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Edgar Benitez

edgar.benitez@yale.edu

Principal Investigator:

Daniel Rubio, MD

Kansas Joint and Spine Specialists

Recruiting

Wichita, Kansas, United States, 67226

Contacts

Collin Nevil, MD

cnevil2@kumc.edu

Jaden Hutfles, NP

jhutfles@ksjointspine.com

Principal Investigator:

M. Camden Whitaker, MD

Orthopaedic Institute of Western Kentucky

Recruiting

Paducah, Kentucky, United States, 42001

Contacts

Rebekah Vinson

270-442-9461rvinson@oiwky.com

Principal Investigator:

K. Brandon Strenge, MD

New England Baptist Hospital

Recruiting

Boston, Massachusetts, United States, 02120

Contacts

Lauren Schoeller

617-754-6609lschoell@nebh.org

Ruijia Niu

617-754-6609rniu@nebh.org

Principal Investigator:

Raymond Hwang, MD

Tennessee Orthopaedic Alliance

Recruiting

Nashville, Tennessee, United States, 37209

Contacts

Erika Frazier

FrazierEE@TOA.COM

Principal Investigator:

Ryan Snowden, MD

Austin Neurosurgeons

Recruiting

Austin, Texas, United States, 78746

Contacts

Kelly Van Schouwen, MS, ACRP-CP

737-249-0275kelly@researchtex.com

Principal Investigator:

Daniel Peterson, MD

OrthoVirginia

Recruiting

Richmond, Virginia, United States, 23235

Contacts

Erin Brown, LPN

804-806-3903Erin.Brown@orthovirginia.com

Principal Investigator:

Joshua Herzog, MD

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Jennifer Eicher

304-293-1074jeicher@hsc.wvu.edu

Principal Investigator:

Scott Daffner, MD

More Information

Sponsor

Bioventus LLC

Last update posted

Aug 28, 2023

Last verified

Aug, 2023

Keywords

  • Lumbar Interbody Fusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Bioventus LLC on 2023-08-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.