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

Spondylolisthesis, Grade 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06415110
• Other study ID #: Allosync Expand
• Status: Enrolling by invitation
• Start date: May 2024
• Est. completion date: May 2027

Study information

• Verified date: May 2024
• Source: Research Source
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: May 2027
• Est. primary completion date: May 2026
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spondylolisthesis
• Spondylolisthesis, Grade 1

Intervention

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

Locations

Country	Name	City	State
United States	Michigan Orthopaedic Surgeons	Southfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Research Source

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lumbar fusion rate assessed via CT	Lumbar fusion rate assessed via CT at 12 months post surgery	12 months post surgery
Secondary	Clinical outcome via neck visual analog scale (VAS)	Standard of care patient reported neck visual analog scale (VAS) will be used to evaluate patient pain. On a scale of 0 to 10 with a score of 0 being no pain and a score of 10 being worst pain. A low score means a better clinical outcome. A high score means a worse clinical outcome.	12 months post surgery
Secondary	Clinical outcome via Overall Quality of Life (EQ-5D) EuroQol Research Foundation	Standard of care patient reported Overall Quality of Life (EQ-5D) EuroQol Research Foundation will be used to evaluate patient quality of life. On a scale of 3 levels: no problems, some problems, and extreme problems. With a score of "no problems" being no interference in quality of life and a score of "extreme problems" being a high interference in quality of life. "No problems" responses means a better clinical outcome. "Extreme problems" responses mean a worse clinical outcome.	12 months post surgery
Secondary	Clinical outcome via PROMIS short form - Physical Evaluation	Standard of care patient reported PROMIS short form - Physical Evaluation will be used to evaluate patient physical function. On a scale of 5 levels: without any difficulty, with a little difficulty, with some difficulty, with much difficulty, and unable to do. With a score of "without any difficulty" being no interference in physical function and a score of "unable to do" being high interference in physical function. "Without any difficulty" means a better clinical outcome. "Unable to do" means a worse clinical outcome.	12 months post surgery