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

ConditionKnee Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorSt. Olavs Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primary reconstruction of ACL ruptures

Surgery at least 6 weeks after injury

The patient must accept and sign the informed consent form before surgery

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endobutton CL BTB

    Device

    ACL reconstruction with Endobutton CL BTB

  • Metal interference screw

    Device

    ACL reconstruction with metal interference screw

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Endobutton CL BTBExperimental treatment 1 intervention
Group B: Metal interference screwActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Knee related quality of life

KOOS subscale "knee related Quality of life (QOL)"

Time frame
2 years

Secondary outcomes

1

Tegner activity scale

Time frame
6 months, 2 years, 10 years
2

Lachman test

Anterior translation of the tibia

Time frame
6 weeks, 6 months, 2 years, 10 years
3

Muscular strength

Biodex dynamometer

Time frame
6 months, 2 years, 10 years
4

Bone block integration

CT scan

Time frame
6 months

Other outcomes

1

Complications

Registration

Time frame
Up to 10 years
2

Reoperations

Registration

Time frame
Up to 10 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Olavs Hospital

Lead sponsor

Rosenborgklinikken

Collaborator