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Clinical Trials/NCT04940169
NCT04940169
Completed
Not Applicable

Prospective Comparison Of Arthroscopic Anterior Cruciate Ligament Reconstrictions Made With Hamstring Tendon And Quadriceps Tendon Autografts

SB Istanbul Education and Research Hospital1 site in 1 country38 target enrollmentJuly 6, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Injuries
Sponsor
SB Istanbul Education and Research Hospital
Enrollment
38
Locations
1
Primary Endpoint
VAS
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Anterior cruciate ligament reconstruction (ACLR) is one of the most common procedure all around the world, however optimal graft source for ACLR still remains controversial. Although Quadriceps tendon (QT) is the least used and least studied autograft, it could be an appropriate and good alternative for ACLR. If investigaters use the same surgical technique, and exert the same rehabilitation methods they may have better results than hamstring tendon (HT) autografts.

Detailed Description

Investigators enrolled 36 patient and randomized them to different group (HT, QT). at the first evaluation examination findings noted, PROMs (patient reported outcome measurements) questioned, thigh circumference measured, flexor and extensor thigh muscle strength recorded with help of Humac CYBEX Norm (CSMI, 2004) device. After these examinations and preparations all patients operated by the same surgeon who is familiar with both technique. The same surgical technique and fixation method used for both groups. At 1st year follow-up all evaluations PROMs (İKDC,lysholm,VAS) and measurements repeated. Back to the sports rates and postoperative complications compared between HT-QT.

Registry
clinicaltrials.gov
Start Date
July 6, 2018
End Date
March 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
SB Istanbul Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Neset Tang

attendant

SB Istanbul Education and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • diagnosed primary ACL rupture willing to involve study
  • lesser than Outerbridge 2 cartilage lesions, non-buckethandle meniscus injuries

Exclusion Criteria

  • more than one ligament injury greater than outerbridge 3 cartilage injury buckethandle meniscus injuries re-ruptures bilateral injuries previous knee surgery any disease affecting muscle strength

Outcomes

Primary Outcomes

VAS

Time Frame: Change from baseline score at one year.

Simple patient reported questionnaire

KOOS

Time Frame: Change from Baseline score at one year.

Simple patient reported questionnaire

lysholm

Time Frame: Change from Baseline score at one year.

Simple patient reported questionnaire

IKDC

Time Frame: Change from baseline score at one year.

Simple patient reported questionnaire

STRENGTH TEST

Time Frame: Change from baseline score at one year.

Simple patient reported questionnaire

subjective instability test

Time Frame: Change from baseline score at one year.

instability measure with help of examinations

thigh circumference

Time Frame: Change from baseline score at one year.

circumference measure

one leg hop test

Time Frame: Change from baseline score at one year.

ask to participant hop on operated leg

Study Sites (1)

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