Optimizing Graft Selection for ACL Reconstruction

NCT05342441 | Recruiting DMC

• 1 other identifier: GRASE ACL
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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
• \- Patient reported effect of graft choice in ACL reconstruction
• \- Biomechanical effect of graft choice in ACL reconstruction
• \- Clinical effect of graft choice in ACL reconstruction

Conditions

ACL - Anterior Cruciate Ligament Rupture

Keywords

ACL reconstruction; Graft choice; Quadriceps graft; Semitendinosus/gracilis graft; Muscle morphology; Neuromuscular control; BPTB graft; Patient reported function

Outcome Measures

Primary Outcomes (2)

• 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.

  12 months follow up.

• 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.

  12 months follow up

Secondary Outcomes (15)

• International Knee Documentation Committee score (IKDC).

  Baseline, 1, 6, and 24 months follow up.

• Donor site discomfort.

  Baseline, 6, 12, and 24 months follow up.

• Return to sport questionnaire.

  Baseline, 6, 12 and 24 months follow up.

• Workability questionnaire

  Baseline, 1, 6, 12, and 24 months follow up.

• Patient Acceptable Symptom State questionnaire (PASS)

  Baseline, 12, and 24 months.

Other Outcomes (5)

• Psychological consequences

  1, 6, 12, and 24 months follow up.

• Clinical knee range of motion

  6 and 12 months follow up.

• One-leg jump performance

  6 and 12 months follow up

Study Arms (3)

QT-graft

EXPERIMENTAL

Quadriceps tendon autograft (n=50)

Procedure: QT graft

St/Gr-graft

EXPERIMENTAL

Semitendinosus/gracilis autograft (n=50)

Procedure: ST/Gr graft

BPTB-graft

EXPERIMENTAL

Patella tendon autograft (n=50)

Procedure: BPTB graft

Interventions

QT graft PROCEDURE

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.

QT-graft

ST/Gr graft PROCEDURE

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.

St/Gr-graft

BPTB graft PROCEDURE

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.

BPTB-graft

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• clinically confirmed first-time ACL rupture
• 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.

You may not qualify if:

• 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
• Known osteoarthritis (Kelgren Lawrence score ≥ 2)
• Prior open surgery to either knee
• Prior severe fracture involving knee joint surfaces
• Prior severe injury to thigh muscles in either leg (e.g. tear or compartment)
• Prior severe injury to the patella tendon of either knee (e.g. subluxation)
• Medical condition preventing full participation (e.g. active cancer, - rheumatoid arthritis)
• Psychiatric condition preventing full participation
• Pregnancy
• Obesity (BMI \> 30)
• Medial meniscus lesion \> 50%
• Lateral meniscus lesion \> 50%

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• University College Copenhagen: collaborator
• National Research Centre for the Working Environment, Denmark: collaborator

Study Sites (1)

Copenhagen University Hospital - Amger/Hvidovre

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Per Hölmich, D.M.Sc/D.Sc

  Hvidovre UH

  STUDY DIRECTOR

• Mette K Zebis, MSc, PhD

  University College Copenhagen

  STUDY DIRECTOR

Central Study Contacts

Merete B Speedtsberg, MSc

CONTACT

+45 38622381; MSPE0006@regionh.dk

Cecilie K Olsen, MD

CONTACT

+45 24899115; cecilie.koellner.olsen.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to group allocation. Before each patient visit, tape will be placed on possible scars to hide donor graft site. Given the nature of the intervention, blinding of patients and surgeons is not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, MD, PhD, Associate Professor

Model Details: Prospective, assesor blinded randomized controlled study

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 22, 2022
• Study Start: May 9, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 31, 2028
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after publication
• Access Criteria: By request to central contact

Locations

DK (1)