A Prospective Analysis of the Efficacy of Allosync Expand and Autograft Bone Graft in Open Lumbar Spinal Fusion

Study Purpose

The purpose of this study is to assess the radiographic and clinical outcomes of spinal fusion following use of Allosync Expand and autograft bone graft.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
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	22 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. At least 22years of age at the time of consent. 2. Subject must have a documented diagnosis of spondylolisthesis up to Grade

I. and have confirmed back and/or radicular pain with associated spinal stenosis as documented by conditions such as: 1.

Instability as defined by >3mm translation or >5 degree angulation. 2. Osteophyte formation of facet joints or vertebral endplates. 3. Subject presents with one or more of the following: 1. Radiculopathy. 2. Sensory deficit. 3. Motor weakness. 4. Reflex changes. 4. Subject requires lumbar posterolateral arthrodesis at 1-3 contiguous levels (L1-S1). 5. The number of levels decompressed must equal the number of levels fused. 6. Subject must have been unresponsive to conservative care for at least 3 months prior to fusion surgery. 7. Subject must be willing and able to sign an informed consent document. 8. Subject must be willing and able to return for all follow-up visits, agree to participate in postoperative clinical and radiographic evaluations and comply with the required study regimen.

Exclusion Criteria:

1. Subject has had prior lumbar spine fusion surgery at any level. 2. Subject has greater than grade 1 spondylolisthesis of the lumbar spine. 3. Subject is pregnant or nursing or planning to become pregnant during the two years (24 months) following arthrodesis. 4. Subject has an active local or systemic infection. 5. Subject is a prisoner. 6. Patient has any condition (including malignancy), that in the opinion of the Investigator, would prohibit the patient from complying with and/or completing the protocol

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.	NCT06415110
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.	Research Source
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.	Other
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Spondylolisthesis, Grade 1

Additional Details

This is a single site, prospective study with patients selected as study subjects from the Investigator's standard patient population who fulfill the Inclusion/Exclusion Criteria and agree to participate in the study. The study surgery is standard of care, with patients identified as requiring surgery prior to enrollment. The study surgery is lumbar posterior fixation with supplemental posterolateral fusion at from 1 to 3 levels. One side of the posterolateral fusion will be Allosync Expand (utilizing the BMA Angel kit to hydrate) and the other side to autograft bone (control).

Arms & Interventions

Arms

: Allosync Expand

All enrolled patients will received Allosync Expand at 1-3 contiguous levels (L1-S1).

Interventions

Device: - Allosync Expand

Allosync Expand is used in lumbar posterolateral arthrodesis at 1-3 contiguous levels (L1-S1)

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.

Michigan Orthopaedic Surgeons, Southfield, Michigan

Status

Address

Michigan Orthopaedic Surgeons

Southfield, Michigan, 48033

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