Prediction of Rectus Femoris Graft Size in ACL Reconstruction

April 18, 2026 updated by: Ahmet Emin Okutan, Samsun University

Prediction of Quadrupled Rectus Femoris Graft Diameter Using Anthropometric and Tendon Parameters

This study aims to develop and validate a predictive model for estimating the diameter of a quadrupled rectus femoris tendon graft used in anterior cruciate ligament (ACL) reconstruction. By analyzing patient anthropometric characteristics and intraoperative tendon measurements, we aim to identify reliable predictors of graft size to improve preoperative planning and surgical decision-making.

Study Overview

Status

Recruiting

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

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing ACL reconstruction with rectus femoris tendon autograft at a tertiary orthopedic center.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2026

Primary Completion (Estimated)

July 10, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

April 5, 2026

First Submitted That Met QC Criteria

April 12, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 18, 2026

Last Verified

April 1, 2026

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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