Spinal DiseaseNCT04775537
OssiMend BA in Posterolateral Instrumented Lumbar Fusion
An observational study of Spinal Disease and Degenerative Disc Disease, run by Collagen Matrix at 4 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Disease, Degenerative Disc Disease
- What is being tested?
- OssiMend™ Bioactive Moldable
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Jan 2021to 30 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 3 recruiting
- Not yet recruiting
San Diego Neurosurgery
Encinitas, California, 92024
Kevin Yoo
Kevin Yoo, M.D., F.A.A.N.S., F.A.C.S.
- Completed
McKenzie-willamette Medical Center
Eugene, Oregon, 97401
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06102
Nabil Matmati, 203-939-5362, nabil.matmati@hhchealth.org
Pedro Coutinho, MD
- Not yet recruiting
University Orthopaedic Associates, Division of OrthoNJ
Somerset, New Jersey, 08873
Patricia Seuffert, patricias@uognj.com
Matthew McDonnell, MD
About this study
Official title: 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
Read the 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).
- Conditions
- Spinal Disease, Degenerative Disc Disease
- Being tested
- OssiMend™ Bioactive Moldable
- Keywords
- Bone Graft, Lumbar Fusion
- Medical subject headings
- Spinal Diseases, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OssiMend™ Bioactive MoldableDevice
Lumbar Spine fusion with OssiMend™ Bioactive Moldable
| Study group | Role | What they receive |
|---|---|---|
| OssiMend™ Bioactive Moldable | Patients undergoing Lumber Spine Fusion Receives: Device: OssiMend™ Bioactive Moldable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion Success
Fusion will be assessed with A/P and Lateral radiographs taken and scored with Lenke's classification of posterolateral fusion success
Measured: 12 months
Secondary outcomes (3)
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)
Measured: 12 months
Oswestry Lower Back Pain Questionnaire
Pain/Disability as measured by Oswestry Lower Back Pain Questionnaire
Measured: 12 months
SF36
Pain and function as measured by the Short - Form 36
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start21 Jan 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Collagen Matrix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775537
- Sponsor's protocol ID
- CIP.072.Spine Prospective
- Status last verified
- Jan 2025
- First submitted
- 11 Feb 2021
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OssiMend Bioactive Moldable in Posterolateral Instrumented Lumbar Fusion
- ClinicalTrials.gov ID
- NCT04775537
- Acronym / sponsor ID
- CIP.072.Spine Prospective
- Conditions
- Spinal Disease, Degenerative Disc Disease
- Keywords
- Bone Graft, Lumbar Fusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Collagen MatrixIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OssiMend™ Bioactive Moldable | – | Device: OssiMend™ Bioactive MoldablePatients undergoing Lumber Spine Fusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OssiMend™ Bioactive MoldableLumbar Spine fusion with OssiMend™ Bioactive Moldable | Device | OssiMend™ Bioactive Moldable |
Primary outcome
Fusion Success
Time frame: 12 months
Fusion will be assessed with A/P and Lateral radiographs taken and scored with Lenke's classification of posterolateral fusion success
3 secondary outcomes
Visual analog scale (VAS) of back and leg (left and right)
Time frame: 12 months
Oswestry Lower Back Pain Questionnaire
Time frame: 12 months
SF36
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Disease and Degenerative Disc Disease, run by Collagen Matrix at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meenakshi Paliwal (12014051477, mpaliwal@collagenmatrix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion Success (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.