Spine FusionNCT05986006

Fusion Status After ACDF

A study testing Anterior Cervical Disc Fusion (ACDF) Surgery w/ machined bone allograft and Anterior Cervical Disc Fusion (ACDF) Surgery w/ Iliac Crest Bone Graft in people with Spine Fusion and Spine Surgery, run by Rothman Institute Orthopaedics at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Spine Fusion, Spine Surgery
What is being tested?: Anterior Cervical Disc Fusion (ACDF) Surgery w/ machined bone allograft and Anterior Cervical Disc Fusion (ACDF) Surgery w/ Iliac Crest Bone Graft
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 124 participants
Where: 1 siteUnited States
Study dates: 7 Aug 2023to 31 Aug 2024
Phase: Interventional
Are there results?: None posted in the registry

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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

patients 18 years of age or older
preoperative diagnosis of cervical radiculopathy and/or cervical myelopathy.

Who cannot join

patients undergoing a revision cervical procedure
current smokers
patient with surgical indications of tumor, infection, or trauma

Trial locations and contacts

1 site in 1 country.

United States1 site

Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: Fusion Status of Machined Allograft Versus Iliac Crest Allograft in Anterior Cervical Discectomy and Fusion: A Randomized Controlled Trial

Read the detailed description

Pseudarthrosis, a failure of bony fusion, is one of the most common causes of revision surgery following anterior cervical discectomy and fusion (ACDF). The interbody spacer is an important component of bony fusion in ACDF, and we aim to compare machined allograft spacers versus iliac crest allograft in a randomized controlled trial. We hypothesize that iliac crest allograft will improve anterior cervical discectomy and fusion arthrodesis rates and diminish the amount of intervertebral graft resorption when compared to off-the-shelf machined allografts

Conditions: Spine Fusion, Spine Surgery
Being tested: Anterior Cervical Disc Fusion (ACDF) Surgery w/ machined bone allograft, Anterior Cervical Disc Fusion (ACDF) Surgery w/ Iliac Crest Bone Graft

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anterior Cervical Disc Fusion (ACDF) Surgery w/ machined bone allograftProcedure or surgery
Participant will undergo primary, elective one-level to four-level ACDF using machined bone allograft
Anterior Cervical Disc Fusion (ACDF) Surgery w/ Iliac Crest Bone GraftProcedure or surgery
Participant will undergo primary, elective one-level to four-level ACDF using iliac crest bone allograft

Study groups in NCT05986006
Study group	Role	What they receive
Anterior Cervical Discectomy and Fusion (ACDF) w/Machined Allograft	Active comparator	Participant will undergo primary, elective one-level to four-level ACDF and will be randomized to machined bone allograft Receives: Procedure: Anterior Cervical Disc Fusion (ACDF) Surgery w/ machined bone allograft
Anterior Cervical Discectomy and Fusion (ACDF) w/Iliac Crest Allograft	Active comparator	Participant will undergo primary, elective one-level to four-level ACDF and will be randomized to iliac crest bone allograft Receives: Procedure: Anterior Cervical Disc Fusion (ACDF) Surgery w/ Iliac Crest Bone Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

Improved participant reported outcome measures (PROMs)-1
Investigators will ask participants to complete the Short Form-12 survey (SF-12) at 3 months, 6 months, 12 months, and 24 months following surgery
Measured: 2 years
Improved participant reported outcome measures (PROMs)-2
Investigators will ask participants to complete the Visual Analog Score (VAS) for Neck and Arm, Neck Disability Index (NDI), at 3 months, 6 months, 12 months, and 24 months following surgery
Measured: 2 years
Improved participant reported outcome measures (PROMs)-3
Investigators will ask participants to complete the modified Japanese Orthopaedic Association (mJOA) score) at 3 months, 6 months, 12 months, and 24 months following surgery
Measured: 2 years
Fusion status after surgery
Fusion status will be assessed using Postoperative x-rays (AP, lateral, flexion, extension) which will be taken at 3 months, 6 months, 12 months, and 24 months following surgery
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Aug 202331 Aug 2024

First posted14 Aug 2023
Study start7 Aug 2023 (estimated)
Primary completion31 Aug 2024 (estimated)
Study completion31 Aug 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Spine FusionStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 124 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05986006
Sponsor's protocol ID: AHIL22D.618
Status last verified: Aug 2023
First submitted: 3 Aug 2023
Last updated: 14 Aug 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
OssDsign® Spine Registry Study ("Propel")
Degenerative Disc Disease, Spinal Stenosis
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Not yet recruitingObservational study
Postsurgical Pain and Opioid Use in Older Adults: Effects of Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Opioid Use
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion

All Spine Fusion trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fusion Status of Machined Allograft Versus Iliac Crest Allograft in Anterior Cervical Discectomy and Fusion: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05986006
Acronym / sponsor ID: AHIL22D.618
Conditions: Spine Fusion, Spine Surgery
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 124 participants (estimated)
Lead sponsor: Rothman Institute OrthopaedicsUniversity, hospital or other
Study start: 7 Aug 2023 (estimated)
Primary completion: 31 Aug 2024 (estimated)
Study completion: 31 Aug 2024 (estimated)
First posted: 14 Aug 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Anterior Cervical Discectomy and Fusion (ACDF) w/Machined Allograft	Active comparator	Procedure: Anterior Cervical Disc Fusion (ACDF) Surgery w/ machined bone allograftParticipant will undergo primary, elective one-level to four-level ACDF and will be randomized to machined bone allograft
Anterior Cervical Discectomy and Fusion (ACDF) w/Iliac Crest Allograft	Active comparator	Procedure: Anterior Cervical Disc Fusion (ACDF) Surgery w/ Iliac Crest Bone GraftParticipant will undergo primary, elective one-level to four-level ACDF and will be randomized to iliac crest bone allograft

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

patients 18 years of age or older
preoperative diagnosis of cervical radiculopathy and/or cervical myelopathy.

Key exclusion criteria (3 listed)

patients undergoing a revision cervical procedure
current smokers
patient with surgical indications of tumor, infection, or trauma

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
Anterior Cervical Disc Fusion (ACDF) Surgery w/ machined bone allograftParticipant will undergo primary, elective one-level to four-level ACDF using machined bone allograft	Procedure or surgery	Anterior Cervical Discectomy and Fusion (ACDF) w/Machined Allograft
Anterior Cervical Disc Fusion (ACDF) Surgery w/ Iliac Crest Bone GraftParticipant will undergo primary, elective one-level to four-level ACDF using iliac crest bone allograft	Procedure or surgery	Anterior Cervical Discectomy and Fusion (ACDF) w/Iliac Crest Allograft

Primary outcome

Improved participant reported outcome measures (PROMs)-1
Time frame: 2 years
Investigators will ask participants to complete the Short Form-12 survey (SF-12) at 3 months, 6 months, 12 months, and 24 months following surgery
Improved participant reported outcome measures (PROMs)-2
Time frame: 2 years
Investigators will ask participants to complete the Visual Analog Score (VAS) for Neck and Arm, Neck Disability Index (NDI), at 3 months, 6 months, 12 months, and 24 months following surgery
Improved participant reported outcome measures (PROMs)-3
Time frame: 2 years
Investigators will ask participants to complete the modified Japanese Orthopaedic Association (mJOA) score) at 3 months, 6 months, 12 months, and 24 months following surgery
Fusion status after surgery
Time frame: 2 years
Fusion status will be assessed using Postoperative x-rays (AP, lateral, flexion, extension) which will be taken at 3 months, 6 months, 12 months, and 24 months following surgery

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.

Related trials for Spine Fusion

RecruitingObservational study
OssDsign® Spine Registry Study ("Propel")
Degenerative Disc Disease, Spinal Stenosis
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Not yet recruitingObservational study
Postsurgical Pain and Opioid Use in Older Adults: Effects of Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Opioid Use
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion

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. This study is not recruiting at the moment.

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?

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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. 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?

Results are not available in the source record.

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?

Improved participant reported outcome measures (PROMs)-1 (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05986006.

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 14 Aug 2023.