Spondylolisthesis, Grade 1NCT06415110
A Prospective Analysis of the Efficacy of Allosync Expand and Autograft Bone Graft in Open Lumbar Spinal Fusion
An observational study of Spondylolisthesis, Grade 1, run by Research Source at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Spondylolisthesis, Grade 1
- What is being tested?
- Allosync Expand
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2024to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- 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.
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Michigan Orthopaedic Surgeons
Southfield, Michigan, 48033
About this study
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.
Read the 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
- Spondylolisthesis, Grade 1
- Being tested
- Allosync Expand
- Medical subject headings
- Spondylolisthesis, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allosync ExpandDevice
Also called Acceell Family of Products (Accell DBM 100, Accell TBM, A2i, and Accell Connexus)
Allosync Expand is used in lumbar posterolateral arthrodesis at 1-3 contiguous levels (L1-S1)
| Study group | Role | What they receive |
|---|---|---|
| Allosync Expand | All enrolled patients will received Allosync Expand at 1-3 contiguous levels (L1-S1). Receives: Device: Allosync Expand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar fusion rate assessed via CT
Lumbar fusion rate assessed via CT at 12 months post surgery
Measured: 12 months post surgery
Secondary outcomes (3)
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.
Measured: 12 months post surgery
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.
Measured: 12 months post surgery
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.
Measured: 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start5 Jun 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spondylolisthesis, Grade 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Source
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415110
- Sponsor's protocol ID
- Allosync Expand
- Status last verified
- Aug 2025
- First submitted
- 10 May 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Analysis of the Efficacy of Allosync Expand and Autograft Bone Graft in Open Lumbar Spinal Fusion
- ClinicalTrials.gov ID
- NCT06415110
- Acronym / sponsor ID
- Allosync Expand
- Conditions
- Spondylolisthesis, Grade 1
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Research SourceResearch network
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allosync Expand | – | Device: Allosync ExpandAll enrolled patients will received Allosync Expand at 1-3 contiguous levels (L1-S1). |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (14 listed)
- 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:
- Subject presents with one or more of the following:
- Subject requires lumbar posterolateral arthrodesis at 1-3 contiguous levels (L1-S1).
- The number of levels decompressed must equal the number of levels fused.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allosync ExpandAlso: Acceell Family of Products (Accell DBM 100, Accell TBM, A2i, and Accell Connexus)Allosync Expand is used in lumbar posterolateral arthrodesis at 1-3 contiguous levels (L1-S1) | Device | Allosync Expand |
Primary outcome
Lumbar fusion rate assessed via CT
Time frame: 12 months post surgery
Lumbar fusion rate assessed via CT at 12 months post surgery
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylolisthesis, Grade 1, run by Research Source at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar fusion rate assessed via CT (time frame: 12 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.