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

Prospective Comparison Of Arthroscopic Anterior Cruciate Ligament Reconstrictions 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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Procedure: anterior cruciate ligament recontruction

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34098
    • Istanbul Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: quadriceps tendon autograft; Ramdomized half of the patient underwent quadriceps graft harvesting. Arthroscopic technique fixation methods rehabilitation style follow periods kept same as hamstring group except graft type.	Procedure: anterior cruciate ligament recontruction; Firstly graft is harvested with help of arthroscopy femoral and tibial tunnels created then graft placed into tunnels
Experimental: hamstring tendon autograft; Ramdomized half of the patient underwent hamstring graft harvesting. Arthroscopic technique fixation methods rehabilitation style follow periods kept same as hamstring group except graft type.	Procedure: anterior cruciate ligament recontruction; Firstly graft is harvested with help of arthroscopy femoral and tibial tunnels created then graft placed into tunnels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KOOS	Simple patient reported questionnaire	Change from Baseline score at one year.
lysholm	Simple patient reported questionnaire	Change from Baseline score at one year.
VAS	Simple patient reported questionnaire	Change from baseline score at one year.
IKDC	Simple patient reported questionnaire	Change from baseline score at one year.
STRENGTH TEST	Simple patient reported questionnaire	Change from baseline score at one year.
subjective instability test	instability measure with help of examinations	Change from baseline score at one year.
thigh circumference	circumference measure	Change from baseline score at one year.
one leg hop test	ask to participant hop on operated leg	Change from baseline score at one year.

Collaborators and Investigators

• Sponsor: SB Istanbul Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2018
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: IER Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No