RECRUITING

OSTEOAMP Lumbar Fusion Intra-Patient Controlled Study

Conditions

Lumbar Spine Disease Lumbar Spondylolisthesis Lumbar Spine Instability Lumbar Spondylosis Degenerative Disc Disease Lumbar Interbody Fusion

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-05-06

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05405374

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Amanda Doan

CONTACT

(901) 341-2976

amanda.doan@bioventus.com

Adam Waksman, DVM

CONTACT

adam.waksman@bioventus.com

Study Locations (Sites)

Yale University

New Haven, Connecticut, 06510

United States

Kansas Joint and Spine Specialists

Wichita, Kansas, 67226

United States

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42001

United States

Spine Institute of Louisiana

Shreveport, Louisiana, 71101

United States

New England Baptist Hospital

Boston, Massachusetts, 02120

United States

Tennessee Orthopaedic Alliance

Nashville, Tennessee, 37209

United States

Austin Neurosurgeons

Austin, Texas, 78746

United States

OrthoVirginia

Richmond, Virginia, 23235

United States

West Virginia University

Morgantown, West Virginia, 26506

United States

Collaborators and Investigators

Sponsor: Bioventus LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-06

Study Completion Date2025-10

Study Record Updates

Study Start Date2022-05-06

Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

Lumbar Interbody Fusion

Additional Relevant MeSH Terms

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