OssiMend BA in Posterolateral Instrumented Lumbar Fusion | NCT04775537

Studies
OssiMend BA in Posterolateral Instrumented Lumbar Fusion

NCT04775537

Sponsor

Collagen Matrix

Status

Recruiting

Last Update Posted

Oct 16, 2025Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Spinal Disease
Degenerative Disc Disease

Interventions

OssiMend™ Bioactive Moldable

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 21, 2021Actual

Primary Completion Date

Dec 30, 2026Estimated

Completion Date

Jan 30, 2027Estimated

First Submitted Date

Feb 11, 2021

First Submission Date that Met QC Criteria

Feb 25, 2021

First Posted Date

Mar 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2025

Last Update Posted Date

Oct 16, 2025Actual

Description Module

Brief Summary

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OssiMend™ Bioactive Moldable		Patients undergoing Lumber Spine Fusion	Device: OssiMend™ Bioactive Moldable

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OssiMend™ Bioactive Moldable	Device	Lumbar Spine fusion with OssiMend™ Bioactive Moldable	OssiMend™ Bioactive Moldable

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Meenakshi Paliwal	Contact	12014051477		mpaliwal@collagenmatrix.com
Peggy Hansen	Contact	201-405-1477	x304	phansen@collagenmatrix.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Diego Neurosurgery	Not yet recruiting	Encinitas	California	92024	United States

ID	Term
D013122	Spinal Diseases
D055959	Intervertebral Disc Degeneration

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases