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

Knee Injuries Clinical Trial

Official title:

A Prospective Randomized Controlled Trial Comparing the Endobutton CL BTB Fixation System With Metal Interference Screws in the Femoral Fixation of Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02918734
• Other study ID #: 2015/993
• Status: Recruiting
• Phase: N/A
• Start date: October 2016
• Est. completion date: March 2033

Study information

• Verified date: June 2024
• Source: St. Olavs Hospital
• Contact: Trond Olav Lundemo, md
• Email: trond.olav.lundemo[@]stolav.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Primary anterior cruciate ligament (ACL) reconstructions with bone-patellar tendon-bone (BPTB) autografts have recently been found to have a lower risk of revision compared with hamstring tendon autografts, and BPTB has again become our graft of choice. Interference screws have been the standard method for fixing the femoral side of a BPTB graft; however problems such as damage of the graft and failure due to nonparallel screw placement have been reported. Cortical fixation using a suspensory system has been used for soft-tissue graft fixation for several years, and a corresponding device, the Endobutton CL BTB Fixation System (Smith & Nephew, Inc., Andover, MA, USA), has become available for fixation of bone-tendon-bone grafts. The clinical results after fixation with the Endobutton CL BTB have been described as promising; however, no randomized controlled trials comparing these two 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.

In this randomized controlled trial, patients undergoing primary ACL reconstruction will be randomized into either an Endobutton group or an interference screw group. The primary aim of the study is to compare these two fixation methods, assessed by patient reported outcomes, laxity, range of motion and muscle strength. Knee related quality of life 2 years after surgery is the primary outcome, measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) subscale "knee related Quality of life (QOL)". Other aims are to see if there is any difference in the integration of the bone block in the femoral tunnel assessed by CT scan, in the risk of developing osteoarthritis assessed by radiographs, or in the risk of a postoperative complication or revision. The patients will be followed up 6 weeks, 6 months, 2 years and 10 years after surgery. CT scan will be performed after 6 months, and radiographs after 2 years and 10 years. In addition details of the rehabilitation will be recorded. Patients undergoing a revision will be followed up but excluded from further comparisons in the study.

Our hypothesis is that there is no difference in the outcome after primary ACL reconstruction with BPTB autografts using the Endobutton CL BTB or metal interference screw for femoral fixation, both with a metal interference screw for the tibial fixation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: March 2033
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Primary reconstruction of ACL ruptures

• Surgery at least 6 weeks after injury

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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Knee Injuries

Intervention

Device:
• Endobutton CL BTB
ACL reconstruction with Endobutton CL BTB
• Metal interference screw
ACL reconstruction with metal interference screw

Locations

Country	Name	City	State
Norway	Department of Orthopedic Surgery, St Olavs Hospital	Trondheim
Norway	Rosenborgklinikken	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Rosenborgklinikken

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications	Registration	Up to 10 years
Other	Reoperations	Registration	Up to 10 years
Primary	Knee related quality of life	KOOS subscale "knee related Quality of life (QOL)"	2 years
Secondary	Tegner activity scale		6 months, 2 years, 10 years
Secondary	Lachman test	Anterior translation of the tibia	6 weeks, 6 months, 2 years, 10 years
Secondary	Muscular strength	Biodex dynamometer	6 months, 2 years, 10 years
Secondary	Bone block integration	CT scan	6 months
Secondary	Osteoarthritis	X-ray radiographs	2 years, 10 years
Secondary	Range of motion		6 weeks, 6 months, 2 years, 10 years
Secondary	Knee related quality of life	KOOS subscale "knee related Quality of life (QOL)"	6 weeks
Secondary	Knee related quality of life	KOOS subscale "knee related Quality of life (QOL)"	6 months
Secondary	Knee related quality of life	KOOS subscale "knee related Quality of life (QOL)"	10 years
Secondary	Lysholm functional knee score		6 weeks, 6 months, 2 years, 10 years
Secondary	KOOS	Knee injury and Osteoarthritis Outcome Score	6 weeks, 6 months, 2 years, 10 years
Secondary	Pivot shift test	Anteroposterior and rotational stability	6 weeks, 6 months, 2 years, 10 years
Secondary	KT-1000 arthrometer	Anterior translation of the tibia	6 weeks, 6 months, 2 years, 10 years