OssiMend BA in Posterolateral Instrumented Lumbar Fusion

Study Purpose

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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:

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04775537
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Collagen Matrix
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Spinal Disease, Degenerative Disc Disease
Study Website:	View Trial Website

Additional Details

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).

Arms & Interventions

Arms

: OssiMend™ Bioactive Moldable

Patients undergoing Lumber Spine Fusion

Interventions

Device: - OssiMend™ Bioactive Moldable

Lumbar Spine fusion with OssiMend™ Bioactive Moldable

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

San Diego Neurosurgery, Encinitas 5346646, California 5332921

Status

Not yet recruiting

Address

San Diego Neurosurgery

Encinitas 5346646, California 5332921, 92024

Site Contact

Kevin Yoo

[email protected]

12014051477

Hartford Hospital, Hartford 4835797, Connecticut 4831725

Status