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Clinical Trials/NCT06617559
NCT06617559RecruitingNot Applicable

A Prospective Comparison of Clinical and Radiological Maturation Outcomes of Autologous Quadriceps and Hamstring Tendon Grafts in Anterior Cruciate Ligament Reconstruction

Muzaffer Agir1 site in 1 country25 target enrollmentStarted: May 14, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
25
Locations
1
Primary Endpoint
Stability of Knee

Study Overview

Brief Summary

With the recent technological advancements, the use of the quadriceps tendon with an all-inside technique has come to the forefront, and large-scale research has focused especially on quadriceps tendon grafts. Clinical study results have reported that the outcomes are similar to those of patellar tendon grafts and either equivalent or superior to hamstring tendon grafts.

The aim of this study is the prospective comparison of the clinical and radiological outcomes of patients who underwent anterior cruciate ligament (ACL) reconstruction with autologous hamstring and quadriceps tendon grafts.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Elite athletes
  • •Amateur athletes
  • •Anterior cruciate ligament injury

Exclusion Criteria

  • •Revision surgery
  • •Another ligament injury ( medial collateral ligament, lateral collateral ligament, etc.. )
  • •> Grade-2 cartilage injury
  • •Having previously undergone surgery on the same knee
  • •< 18 years age

Arms & Interventions

All-inside Quadriceps Tendon Graft Group

Experimental

Intervention: Anterior Cruciate Ligament Reconstruction with Quadriceps Autograft (Procedure)

All-inside Hamstring Tendon Graft Group

Experimental

Intervention: Anterior Cruciate Ligament Reconstruction with Hamstring Autograft (Procedure)

Outcomes

Primary Outcomes

Stability of Knee

Time Frame: 9 months

Pivot shift test

Autograft Maturation

Time Frame: 12 months

Comparison of different autografts maturation on MRI images. The signal-to-noise quotient formula will be used to assess graft maturation. According to the method described by Chan and Yau, the difference between the signals of the ACL graft and the quadriceps tendon will be used to evaluate maturation by relating it to the background signal.

Secondary Outcomes

  • Range of Motion(6 months)
  • Muscle Strength(9 months)

Investigators

Sponsor
Muzaffer Agir
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Muzaffer Agir

Medical Doctor

Acibadem University

Study Sites (1)

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