OssiMend BA in Posterolateral Instrumented Lumbar Fusion

OssiMend Bioactive Moldable in Posterolateral Instrumented Lumbar Fusion

The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material

Study Overview

• Status: Recruiting
• Conditions: Degenerative Disc Disease; Spinal Disease
• Intervention / Treatment: Device: OssiMend™ Bioactive Moldable

Detailed Description

The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material. The primary endpoints are radiographic evidence of fusion and the absence of serious adverse events attributable to OssiMend Bioactive Moldable. The secondary objective is to evaluate the clinical outcomes over a period of 1 year (2 years, if possible).

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Peggy Hansen; Phone Number: x304 201-405-1477; Email: phansen@collagenmatrix.com
• Study Contact Backup: Name: Meenakshi Paliwal; Phone Number: 12014051477; Email: mpaliwal@collagenmatrix.com

Study Locations

• United States
  • California
    • Encinitas, California, United States, 92024
      • Not yet recruiting
      • San Diego Neurosurgery
      • Contact: Kevin Yoo
      • Principal Investigator: Kevin Yoo, M.D., F.A.A.N.S., F.A.C.S.
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Recruiting
      • Hartford Hospital
      • Contact: Nabil Matmati; Phone Number: 203-939-5362; Email: nabil.matmati@hhchealth.org
      • Principal Investigator: Pedro Coutinho, MD
  • New Jersey
    • Somerset, New Jersey, United States, 08873
      • Not yet recruiting
      • University Orthopaedic Associates, Division of OrthoNJ
      • Contact: Patricia Seuffert; Email: patricias@uognj.com
      • Principal Investigator: Matthew McDonnell, MD
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Completed
      • McKenzie-willamette Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects must be 18 years of age or older at the time of consent and must have a documented diagnosis of degenerative disc disease (DDD) that has failed to respond to nonoperative treatment for at least 6 months

Description

Inclusion Criteria:

• Subject must be 18 years of age or older at the time of consent and must have a documented diagnosis of degenerative disc disease (DDD) that has failed to respond to nonoperative treatment for at least 6 months. DDD is defined by back and/or radicular pain with degeneration of the disc as confirmed by medical history, physical examination, and radiographic studies that may include CT, MRI, plain X-ray film, discography, myelography, etc. with one or more of the following findings:

  • Instability as defined by >3mm translation or >5 degrees angulation
  • Osteophyte formation of facet joints or vertebral endplates
  • Decreased disc height, on average by >2mm, but dependent upon the spinal level
  • Herniated nucleus pulposus
  • Facet joint degeneration/changes

Exclusion Criteria:

1. Subject is under 18 years of age at the time of consent
2. Subject has had prior lumbar spine fusion surgery at any level
3. Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy
4. Subject is pregnant or nursing or planning to become pregnant during the two years (24 months) following arthrodesis
5. Subject has an active (local or systemic) infection or is undergoing adjunctive treatment for infection
6. Subjects under workers compensation or active litigation

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OssiMend™ Bioactive Moldable; Patients undergoing Lumber Spine Fusion	Device: OssiMend™ Bioactive Moldable; Lumbar Spine fusion with OssiMend™ Bioactive Moldable

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion Success	Fusion will be assessed with A/P and Lateral radiographs taken and scored with Lenke's classification of posterolateral fusion success	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale (VAS) of back and leg (left and right)	Improvement of pain as defined by the Visual analog scale (VAS) of back and leg (left and right)	12 months
Oswestry Lower Back Pain Questionnaire	Pain/Disability as measured by Oswestry Lower Back Pain Questionnaire	12 months
SF36	Pain and function as measured by the Short - Form 36	12 months

Collaborators and Investigators

• Sponsor: Collagen Matrix

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Estimated): October 16, 2025
• Last Update Submitted That Met QC Criteria: October 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Bone Graft; Lumbar Fusion
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Intervertebral Disc Degeneration; Spinal Diseases
• Other Study ID Numbers: CIP.072.Spine Prospective

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No