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Impact of Lateral Bone Grafting With Intraoperative Fusion in ACDF on Clinical Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06027827
Recruitment Status : Recruiting
First Posted : September 7, 2023
Last Update Posted : September 7, 2023
Sponsor:
Information provided by (Responsible Party):
Xuanwu Hospital, Beijing

Study Description
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Brief Summary:
The purpose of this trial was to investigate the safety and efficacy of fuser lateral bone grafting in ACDF. By observing the intervertebral bony fusion rate and clinical outcome scores of patients after fusion device lateral bone grafting, it was verified whether the fusion device lateral bone grafting approach could improve the bony fusion rate and clinical outcome of ACDF.

Condition or disease Intervention/treatment
Cervical Spondylosis Procedure: Addition of fusion device lateral bone graft

Detailed Description:
The study will include patients who underwent 1-2 segment ACDF surgery, in addition to conventional surgical operations, the appropriate amount of allograft bone was implanted in the joint space of the hook vertebrae lateral to the fusion device, and X-rays and CTs were reviewed in the immediate postoperative period, March, June, and December, to verify intervertebral osseous fusion, as well as to observe the patient's clinical outcomes.
Study Design
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Study Type : Observational
Estimated Enrollment : 58 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Lateral Bone Grafting With Intraoperative Fusion in ACDF on Clinical Outcomes
Actual Study Start Date : December 1, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Groups and Cohorts
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Group/Cohort Intervention/treatment
experimental group
In addition to the central bone graft of the fusion cage, the lateral bone graft of the fusion cage was added.
 Procedure: Addition of fusion device lateral bone graft
In addition to the central bone graft of the fusion cage, the lateral bone graft of the fusion cage was added.
control group
Conventional bone grafting in the center of the fusion


Outcome Measures
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Primary Outcome Measures :
  1. Intervertebral bone fusion rate [ Time Frame: 3rd month (±15 days), 6th month (±15 days), 1 year (±30 days) postoperatively ]
    primary Indicator


Secondary Outcome Measures :
  1. JOA [ Time Frame: Preoperative, 7 days postoperative, 3rd month (±15 days), 6th month (±15 days), 1 year (±30 days) ]
    Japanese Orthopaedic Association Scores


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Between the ages of 18-60 years; patients with cervical spondylosis about to undergo 1-2 segment ACDF surgery
Criteria

Inclusion Criteria:

  • Age between 18-60 years old; patients with cervical spondylosis who were about to undergo 1-2 segment ACDF surgery; agreement with the surgical plan and willingness to undergo long-term clinical follow-up; and signing of an informed consent form.

Exclusion Criteria:

  • Drug or alcohol abusers; those with abnormal liver or kidney function unsuitable for surgery; those with cardiac insufficiency unsuitable for surgery; those with severe metabolic and endocrine diseases unsuitable for surgery; those with severe lung disorders such as asthma and abnormal lung function unsuitable for surgery; pregnant and breastfeeding women as well as those who are planning to become pregnant in the near future; those who have participated in other clinical trials within 3 months; and those who are not suitable for participation in the experiment in the opinion of the investigator.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06027827


Contacts
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Contact: Fengzeng Jian, MD, PhD 135 5206 7268 fengzengjian@hotmail.com

Locations
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China, Beijing
Xuanwu Hospital, Capital Medical University Recruiting
Beijing, Beijing, China
Contact: Fengzeng jian, MD,PhD    135 5206 7268    fengzengjian@hotmail.com   
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
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Study Chair: Fengzeng Jian, MD, PhD Xuanwu Hospital, Beijing
More Information
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Publications of Results:

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Responsible Party: Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT06027827    
Other Study ID Numbers: XuanwuACDF
First Posted: September 7, 2023    Key Record Dates
Last Update Posted: September 7, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases