## Protocol Section
### Identification Module
**NCT ID:** NCT06415110

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

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

#### Organization Study ID Info
**ID:** Allosync Expand
#### Organization
**Class:** NETWORK
**Full Name:** Research Source
### Status Module
#### Completion Date
**Date:** 2027-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2026-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** NETWORK

**Name:** Research Source

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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).

### Conditions Module

**Conditions:**

- Spondylolisthesis, Grade 1

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: Allosync Expand

**Label:** Allosync Expand

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Allosync Expand

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

**Name:** Allosync Expand

**Other Names:**

- Acceell Family of Products (Accell DBM 100, Accell TBM, A2i, and Accell Connexus)

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Lumbar fusion rate assessed via CT at 12 months post surgery

**Measure:** Lumbar fusion rate assessed via CT

**Time Frame:** 12 months post surgery

#### Secondary Outcomes

**Description:** 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.

**Measure:** Clinical outcome via neck visual analog scale (VAS)

**Time Frame:** 12 months post surgery

**Description:** 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.

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

**Time Frame:** 12 months post surgery

**Description:** 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.

**Measure:** Clinical outcome via PROMIS short form - Physical Evaluation

**Time Frame:** 12 months post surgery

### Eligibility Module

**Eligibility 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

**Minimum Age:** 22 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Southfield

**Country:** United States

**Facility:** Michigan Orthopaedic Surgeons

**State:** Michigan

**Zip:** 48033

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013169

- Term: Spondylolysis

- ID: D000055009

- Term: Spondylosis

- ID: D000013122

- Term: Spinal Diseases

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M15963

- Name: Spondylolisthesis

- Relevance: HIGH

- As Found: Spondylolisthesis

- ID: M15964

- Name: Spondylolysis

- Relevance: LOW

- As Found: Unknown

- ID: M27993

- Name: Spondylosis

- Relevance: LOW

- As Found: Unknown

- ID: M15919

- Name: Spinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013168

- Term: Spondylolisthesis

### Misc Info Module

- Version Holder: 2024-05-31
