Fusion Status After ACDF

NCT ID: NCT05986006

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-07

Study Completion Date

2024-08-31

Brief Summary

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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.

Detailed Description

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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

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Spine Fusion Spine Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Anterior Cervical Discectomy and Fusion (ACDF) w/Machined Allograft

Participant will undergo primary, elective one-level to four-level ACDF and will be randomized to machined bone allograft

Group Type ACTIVE_COMPARATOR

Anterior Cervical Disc Fusion (ACDF) Surgery w/ machined bone allograft

Intervention Type PROCEDURE

Participant will undergo primary, elective one-level to four-level ACDF using machined bone allograft

Anterior Cervical Discectomy and Fusion (ACDF) w/Iliac Crest Allograft

Participant will undergo primary, elective one-level to four-level ACDF and will be randomized to iliac crest bone allograft

Group Type ACTIVE_COMPARATOR

Anterior Cervical Disc Fusion (ACDF) Surgery w/ Iliac Crest Bone Graft

Intervention Type PROCEDURE

Participant will undergo primary, elective one-level to four-level ACDF using iliac crest bone allograft

Interventions

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Anterior Cervical Disc Fusion (ACDF) Surgery w/ machined bone allograft

Participant will undergo primary, elective one-level to four-level ACDF using machined bone allograft

Intervention Type PROCEDURE

Anterior Cervical Disc Fusion (ACDF) Surgery w/ Iliac Crest Bone Graft

Participant will undergo primary, elective one-level to four-level ACDF using iliac crest bone allograft

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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AHIL22D.618

Identifier Type: -

Identifier Source: org_study_id

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