Optimizing Graft Selection for ACL Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorHvidovre University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Current injury sustai´ned within 2 years
high activity level prior to ACL rupture (Tegner score ≥ 3) and personal goal of returning to physical activity.
Disqualifiers
Inadequate Danish language skills to answer questionnaires.
Prior ligament surgery in the injured knee
Prior ligament surgery in the non-injured knee
Instability of the non-injured knee
Trial design
Design model
Parallel
Treatments tested in this trial
QT graft
Procedure/SurgerySurgical 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.
ST/Gr graft
Procedure/SurgerySurgical 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.
BPTB graft
Procedure/SurgerySurgical 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.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: QT-graftExperimental treatment 1 intervention
Group B: St/Gr-graftExperimental treatment 1 intervention
Group C: BPTB-graftExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
International Knee Documentation Committee score (IKDC).
Patient-reported knee function based on a questionnaire, expressed on a scale form 0-100 with 100 being the best outcome.
Time frame
12 months follow up.2
Rate of Torque Development - Limb Symmetry Index (RFD-LSI).
Hamstring and quadriceps rate of torque development in the injured/operated leg compared to the healthy leg, expressed in percentage with 100% being full symmetry and the best outcome.
Time frame
12 months follow upSecondary outcomes
1
International Knee Documentation Committee score (IKDC).
Patient-reported knee function based on a questionnaire, expressed on a scale form 0-100 with 100 being the best outcome.
Time frame
Baseline, 1, 6, and 24 months follow up.2
Donor site discomfort.
Modified donor-site morbidity score based on the Donor-site-related functional problems questionnaire
Time frame
Baseline, 6, 12, and 24 months follow up.3
Return to sport questionnaire.
Patient-reported ability, level, and performance in the sport, they want to return to following ACL reconstruction. The outcome is comparison of the qualitative data obtained in the questionnaires.
Time frame
Baseline, 6, 12 and 24 months follow up.4
Workability questionnaire
Patient-reported ability and disadvantages when returning to work following ACL reconstruction. The outcome is comparison of the qualitative data obtained in the questionnaires.
Time frame
Baseline, 1, 6, 12, and 24 months follow up.Other outcomes
1
Psychological consequences
The Tampa Scale of Kinesiophobia (TSK-11). Score ranges from 11-44, where 11 means no kinesiophobia and is considered the best outcome.
Time frame
1, 6, 12, and 24 months follow up.2
Clinical knee range of motion
Range Of Motion (ROM) of the knee expressed in degrees from full extension to full flexion. -10 to 130 degrees is consideres normal ROM.
Time frame
6 and 12 months follow up.3
One-leg jump performance
Performance in one-legged return to sport jump tests. Outcome expressed in limb symmetry of distance between injured and non-injured leg
Time frame
6 and 12 months follow up4
Postoperative progress
Patient-reported pain and other complications based on questionnaires via SMS-track
Time frame
Every second week through first year following ACL reconstruction.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hvidovre University Hospital
Lead sponsor
University College Copenhagen
Collaborator
National Research Centre for the Working Environment, Denmark
Collaborator
Source ClinicalTrials.gov