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

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04940169
• Other study ID #: IER Hospital
• Status: Completed
• Phase: N/A
• Start date: July 6, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: June 2021
• Source: SB Istanbul Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

-

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

Procedure:
• anterior cruciate ligament recontruction
Firstly graft is harvested with help of arthroscopy femoral and tibial tunnels created then graft placed into tunnels

Locations

Country	Name	City	State
Turkey	Istanbul education and research hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
SB Istanbul Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

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