Optimizing Graft Selection for ACL Reconstruction

Summary

Purpose:

To investigate the differences between the three most common methods for reconstruction of the anterior cruciate ligament (ACL), to support the development of the best method for the individual patient.

Main research area: ¨ Sports Orthopedic Surgical research.

State of the art:

Every year in Denmark 2500 patients receive surgical reconstruction surgery to replace a ruptured ACL. Many patients experience a decline in knee function and 4-12% suffer a new ACL rupture within 5 years. According to data from the Danish ACL register, three methods of reconstruction are most prevalent, but with large variation between hospitals. This indicates lack of consensus on optimal surgical procedure.

Design:

Assessor-blinded randomized controlled study. 150 patients aged 18-40 with ruptured ACL are allocated to reconstruction with tendon(s) harvested from either the semitendinosus and gracilis, or the patella tendon, or the quadriceps tendon. Patient follow-up will be conducted preoperatively and 1, 6, 12, 24 months postoperatively.

Primary technologies and outcomes:

* Patient-reported knee-joint function, quality of life and donor-site morbidity is obtained with standardized questionnaires. Primary outcome is subjective knee function with the International Knee Documentation Committee evaluation form (IKDC)
* Instrumented analysis of knee-joint coordination and neuromuscular control including 3-D motion capture and electromyography (EMG) during single leg jumps, landings and change-of-direction. Measurement of maximal explosive muscle power in knee extension and flexion. Primary outcome is relative difference between injured and healthy leg in rate of force development (RFD-LSI).
* Standard clinical knee examination of range of motion and instrumented examination of knee-joint stability.
* Magnetic Resonance Imaging (MRI) of the thigh muscles for examination of muscle morphology.

The trial is designed for publication in three primary publications

1. \- Patient reported effect of graft choice in ACL reconstruction
2. \- Biomechanical effect of graft choice in ACL reconstruction
3. \- Clinical effect of graft choice in ACL reconstruction

Additional secondary publications are in the pipeline. Reference to primary protocol and results will always be emphasized in secondary publication to ensure methodological transparency.

Conditions

• ACL - Anterior Cruciate Ligament Rupture

Interventions

PROCEDURE

QT graft

Surgical reconstruction of primary ACL rupture with autograft harvested from the quadriceps tendon without bone block. The QT graft is harvested through a 4-5 cm incision at the upper pole of the patella. A graft sized 10-12 mm in with and app. 6 mm in depth is harvested from the middle part of the tendon. The femoral tunnel is placed anatomically central in the native footprint of the ACL. The tibia tunnel is also placed anatomically; the center of the tunnel being medially between the eminential spines at the level of the posterior margin of the anterior horn of the lateral meniscus. The ST/Gr graft is fixed proximally with the RIGIDFIX® Curve Cross Pin System (DePuy Synthes) and distally with a Milagro skrew (DePuy Synthes) or similar.

PROCEDURE

ST/Gr graft

Surgical reconstruction of primary ACL rupture with autograft harvested from the semitendinosus and gracilis muscles. The ST/Gr graft is harvested through a 4-5 cm incision at the pes anserinus. Both the semitendinosus and the gracilis tendon is identified and harvested. The tendons are prepared and folded to a four-stranded graft with a total diameter of 7-10 mm. The femoral tunnel is placed anatomically central in the native footprint of the ACL. The tibia tunnel is also placed anatomically; the center of the tunnel being medially between the eminential spines at the level of the posterior margin of the anterior horn of the lateral meniscus. The ST/Gr graft is fixed proximally with the RIGIDFIX® Curve Cross Pin System (DePuy Synthes) and distally with a Milagro skrew (DePuy Synthes) or similar.

PROCEDURE

BPTB graft

Surgical reconstruction of primary ACL rupture with autograft harvested from the patella tendon with bone block (bone-patellar-tendon-bone). The BPTB graft is harvested through two 4-5 cm incisions, one on the tibial tuberosity and one on the patella. The middle 10 mm of the patella tendon plus 20-30 mm bone plugs at each end from corresponding tibia and patella is harvested. The femoral tunnel is placed anatomically central in the native footprint of the ACL. The tibia tunnel is also placed anatomically; the center of the tunnel being medially between the eminential spines at the level of the posterior margin of the anterior horn of the lateral meniscus. The BPTB graft is fixed both proximally and distally with a Milagro skrew (DePuy Synthes) or similar.

Sponsors & Collaborators

• University College Copenhagen

  collaborator OTHER

• National Research Centre for the Working Environment, Denmark

  collaborator OTHER_GOV

• Hvidovre University Hospital

  lead OTHER

Principal Investigators

• Per Hölmich, D.M.Sc/D.Sc · Hvidovre UH

• Mette K Zebis, MSc, PhD · University College Copenhagen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-09

Primary Completion

2026-05-31

Completion

2028-05-31

Countries

• Denmark

Study Locations