Fixation of Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction. Endobutton vs Metal Interference Screws

Recruiting now · Not applicable

Conditions studied: Knee Injuries

In brief

In this randomized controlled trial the investigators will compare the results after primary anterior cruciate ligament (ACL) reconstruction using two different methods for femoral fixation of a bone-patellar tendon-bone (BPTB) autograft. Interference screws have been the standard method for fixing the femoral side of BPTB grafts; however, several pitfalls have been reported. Cortical fixation with the Endobutton CL BTB Fixation System has become available and the clinical results have been described as promising; however, no randomized controlled trials comparing these two femoral fixation methods have been conducted, and there is no published data that confirms that the bone block heals in the tunnel with the newer method. The aim of our study is to compare the outcome after primary ACL reconstruction with BPTB autografts using the Endobutton CL BTB or metal interference screw for femoral fixation.

Key facts

Study ID

NCT02918734

Run by

St. Olavs Hospital

People needed

220

Starts

2016-10-01

Expected to finish

2033-03-01

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary reconstruction of ACL ruptures
• Surgery at least 6 weeks after injury
• The patient must accept and sign the informed consent form before surgery

You may not qualify if…

• Medical indication for using another graft than BPTB autograft (such as history of anterior knee pain or occupations etc. requiring frequent kneeling)
• Previous major surgical procedures in the same knee
• Major additional injuries in the knee (posterior cruciate ligament, lateral collateral ligament, medial collateral ligament, sutured meniscus lesions and major cartilage lesions undergoing cartilage repair)
• Contralateral ACL injury (treated or untreated)
• Present or former serious illness that makes follow-up or rehabilitation difficult (e.g. alcohol or drug abuse, psychiatric disease)

Where it is running

• Department of Orthopedic Surgery, St Olavs Hospital — Trondheim, Norway (enrolling)
• Rosenborgklinikken — Trondheim, Norway (enrolling)

Full record on ClinicalTrials.gov

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