NCT07538245

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Apr 2026Aug 2026

First Submitted

Initial submission to the registry

April 5, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

April 18, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 5, 2026

Last Update Submit

April 18, 2026

Conditions

Keywords

rectus femoris graftgraft sizeAnterior curciate ligament

Outcome Measures

Primary Outcomes (1)

  • Quadrupled rectus femoris graft diameter (mm)

    Measured intraoperatively using standard graft sizing tubes

    Baseline

Secondary Outcomes (1)

  • Prediction accuracy (difference between predicted and actual graft diameter)

    Baseline

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients aged 18 years or older
  • Undergoing primary ACL reconstruction
  • Use of rectus femoris tendon autograft
  • Availability of complete anthropometric and intraoperative data

You may not qualify if:

  • Incomplete dataset

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University

Atakent, Samsun, 55200, Turkey (Türkiye)

RECRUITING

Related Links

Central Study Contacts

Ahmet E. Okutan, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 5, 2026

First Posted

April 20, 2026

Study Start

April 18, 2026

Primary Completion (Estimated)

July 10, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations