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

NCT06415110 | Enrolling By Invitation FDA Device

• 1 other identifier: Allosync Expand
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spondylolisthesis, Grade 1

Outcome Measures

Primary Outcomes (1)

• Lumbar fusion rate assessed via CT

  Lumbar fusion rate assessed via CT at 12 months post surgery

  12 months post surgery

Secondary Outcomes (3)

• Clinical outcome via neck visual analog scale (VAS)

  12 months post surgery

• Clinical outcome via Overall Quality of Life (EQ-5D) EuroQol Research Foundation

  12 months post surgery

• Clinical outcome via PROMIS short form - Physical Evaluation

  12 months post surgery

Study Arms (1)

Allosync Expand

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

Device: Allosync Expand

Interventions

Allosync Expand DEVICE

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

Also known as: Acceell Family of Products (Accell DBM 100, Accell TBM, A2i, and Accell Connexus)

Allosync Expand

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A patient who meets all inclusion criteria and none exclusion criteria will be enrolled in the study. A patient is considered enrolled upon placement of the Allosync Expand during the surgical procedure. If the surgeon decides intra-operatively not to utilize Allosync Expand, the patient will be considered a screen failure.

You may qualify if:

• At least 22years of age at the time of consent
• 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:
• Instability as defined by \>3mm translation or \>5 degree angulation
• Osteophyte formation of facet joints or vertebral endplates
• Subject presents with one or more of the following:
• Radiculopathy
• Sensory deficit
• Motor weakness
• Reflex changes
• Subject requires lumbar posterolateral arthrodesis at 1-3 contiguous levels (L1-S1).
• The number of levels decompressed must equal the number of levels fused.
• Subject must have been unresponsive to conservative care for at least 3 months prior to fusion surgery.
• Subject must be willing and able to sign an informed consent document.
• 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.

You may not qualify if:

• Subject has had prior lumbar spine fusion surgery at any level.
• Subject has greater than grade 1 spondylolisthesis of the lumbar spine.
• 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.
• Subject is a prisoner
• 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

Sponsors & Collaborators

• Research Source: lead

Study Sites (1)

Michigan Orthopaedic Surgeons

Southfield, Michigan, 48033, United States

Location

MeSH Terms

Conditions

Spondylolisthesis; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: June 5, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)