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Completed

NCT Number: NCT04940169

Anterior Cruciate Ligament Reconstruction Made With Hamstring Tendon And Quadriceps Tendon Autografts

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul education and research hospital

Istanbul, 34098, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

anterior cruciate ligament recontruction

Procedure

Firstly graft is harvested with help of arthroscopy femoral and tibial tunnels created then graft placed into tunnels

Primary outcomes

  1. KOOS

    Time frame: Change from Baseline score at one year.

    Simple patient reported questionnaire

  2. lysholm

    Time frame: Change from Baseline score at one year.

    Simple patient reported questionnaire

  3. VAS

    Time frame: Change from baseline score at one year.

    Simple patient reported questionnaire

  4. IKDC

    Time frame: Change from baseline score at one year.

    Simple patient reported questionnaire

  5. STRENGTH TEST

    Time frame: Change from baseline score at one year.

    Simple patient reported questionnaire

  6. subjective instability test

    Time frame: Change from baseline score at one year.

    instability measure with help of examinations

  7. thigh circumference

    Time frame: Change from baseline score at one year.

    circumference measure

  8. one leg hop test

    Time frame: Change from baseline score at one year.

    ask to participant hop on operated leg

Sponsors and collaborators

Lead sponsor

SB Istanbul Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 25, 2021
Registry last updated
Jun 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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