OSTEOAMP Lumbar Fusion Intra-Patient Controlled Study (SELECT)

August 25, 2023 updated by: Bioventus LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • Daniel Rubio, MD
        • Sub-Investigator:
          • Peter Whang, MD
    • Kansas
      • Wichita, Kansas, United States, 67226
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Recruiting
        • Orthopaedic Institute of Western Kentucky
        • Contact:
        • Principal Investigator:
          • K. Brandon Strenge, MD
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Active, not recruiting
        • Spine Institute of Louisiana
    • Massachusetts
      • Boston, Massachusetts, United States, 02120
        • Recruiting
        • New England Baptist Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Raymond Hwang, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Recruiting
        • Tennessee Orthopaedic Alliance
        • Contact:
        • Principal Investigator:
          • Ryan Snowden, MD
    • Texas
      • Austin, Texas, United States, 78746
        • Recruiting
        • Austin Neurosurgeons
        • Contact:
        • Sub-Investigator:
          • Randall F. Dryer, MD
        • Principal Investigator:
          • Daniel Peterson, MD
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Recruiting
        • OrthoVirginia
        • Contact:
        • Principal Investigator:
          • Joshua Herzog, MD
        • Sub-Investigator:
          • Adam Crowl, MD
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University
        • Sub-Investigator:
          • Cara Sedney, MD
        • Principal Investigator:
          • Scott Daffner, MD
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: OSTEOAMP
OSTEOAMP SELECT Fibers as an autograft substitute in lumbar interbody fusion procedures
Other: 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.
Active Comparator: Infuse
The Infuse Bone Graft as an autograft substitute in lumbar interbody fusion procedures
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fusion Status
Time Frame: 12 Months
Radiographic fusion as defined by the Image Review Charter and assessed by an independent core laboratory.
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fusion Status
Time Frame: 24 Months
Radiographic fusion as defined by the Image Review Charter and assessed by an independent core laboratory.
24 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Impairment
Time Frame: 24 Months
Derived from the Oswestry Low Back Pain Questionnaire to quantify low back pain and function. Zero is equated with no disability and 100 is the maximum disability possible.
24 Months
Back Pain
Time Frame: 24 Months

Visual Analogue Scale (VAS) change in back pain from baseline to 24 month follow up assessed at time frames: Pre-Op, 6 weeks, 3 month, 6 month, 12 month, 24 month.

Visual Analogue Scale is rated from 0 - 10 cm (no pain - worst possible pain)
24 Months
Leg Pain
Time Frame: 24 Months

Visual Analogue Scale (VAS) change in leg pain from baseline to 24 month follow up assessed at time frames: Pre-Op, 6 weeks, 3 month, 6 month, 12 month, 24 month.

Visual Analogue Scale is rated from 0 - 10 cm (no pain - worst possible pain)
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

May 6, 2022

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

December 9, 2021

First Submitted That Met QC Criteria

June 1, 2022

First Posted (Actual)

June 6, 2022

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGS-21-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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