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Enrolling by invitation NCT06415110

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

— Observational Spondylolisthesis, Grade 1

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Allosync Expand.
Who it may be relevant to
Registry conditions: Spondylolisthesis, Grade 1. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

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).

Interventions

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

Primary outcome measures

  • Lumbar fusion rate assessed via CT [Time frame: 12 months post surgery]
Secondary outcome measures (3)
  • Clinical outcome via neck visual analog scale (VAS) [Time frame: 12 months post surgery]
  • Clinical outcome via Overall Quality of Life (EQ-5D) EuroQol Research Foundation [Time frame: 12 months post surgery]
  • Clinical outcome via PROMIS short form - Physical Evaluation [Time frame: 12 months post surgery]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Michigan Orthopaedic Surgeons — Southfield

Identifiers

NCT: NCT06415110 · Allosync Expand

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗