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Clinical Trials/NCT04940169
NCT04940169CompletedNot Applicable

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

SB Istanbul Education and Research Hospital2 sites in 1 country38 target enrollmentStarted: July 6, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
38
Locations
2
Primary Endpoint
VAS

Study 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.

Study Design

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

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Secondary Outcomes

No secondary outcomes reported

Investigators

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

Neset Tang

attendant

SB Istanbul Education and Research Hospital

Study Sites (2)

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