- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07538245
Prediction of Rectus Femoris Graft Size in ACL Reconstruction
Prediction of Quadrupled Rectus Femoris Graft Diameter Using Anthropometric and Tendon Parameters
Study Overview
Status
Conditions
Detailed Description
Graft diameter is a critical determinant of success in anterior cruciate ligament (ACL) reconstruction. Smaller graft sizes have been associated with increased failure rates. While predictive models exist for hamstring tendon grafts, no validated model currently exists for rectus femoris tendon grafts.
This study seeks to develop a predictive algorithm for estimating the diameter of a quadrupled rectus femoris graft using patient-specific anthropometric and tendon-related variables.
Data will be collected prospectively (or retrospectively if applicable) from patients undergoing ACL reconstruction using rectus femoris tendon autografts. Statistical modeling, including multivariate regression analysis, will be used to identify independent predictors and generate a predictive formula.
The study also aims to evaluate the diagnostic performance of the model in identifying clinically adequate graft sizes (≥8 mm or ≥9 mm).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ahmet E. Okutan, MD
- Phone Number: +905375757657
- Email: ahmeteokutan@yahoo.com
Study Locations
-
-
Samsun
-
Atakent, Samsun, Turkey (Türkiye), 55200
- Recruiting
- Samsun University
-
Contact:
- Ahmet Okutan, MD
- Phone Number: 05375757657
- Email: ahmeteokutan@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 18 years or older
- Undergoing primary ACL reconstruction
- Use of rectus femoris tendon autograft
- Availability of complete anthropometric and intraoperative data
Exclusion Criteria:
- Incomplete dataset
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Standard ACL Reconstruction
Patients undergoing primary ACL reconstruction with rectus femoris tendon autograft will be prospectively enrolled.
The study is observational, and no additional intervention will be performed.
Patient-specific anthropometric measurements and intraoperative graft parameters will be collected to develop and validate a predictive model for graft diameter.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quadrupled rectus femoris graft diameter (mm)
Time Frame: Baseline
|
Measured intraoperatively using standard graft sizing tubes
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prediction accuracy (difference between predicted and actual graft diameter)
Time Frame: Baseline
|
difference between predicted and actual graft diameter
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DEUKAEK2026/12-21
- 2026/12-21 (Other Identifier: Dokuz Eylul University Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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