Clinical and Functional Outcomes at 2 Years of 4-strand Versus 5-strand Hamstring Autograft in Anterior Cruciate Ligament Reconstruction

Study Overview
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Brief Summary
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This study aims to study differences in clinical and functional outcomes at 2 years based on hamstring graft size after single bundle anatomic ACL reconstruction using either 4-strand or 5-strand hamstring grafts. We also propose to study the characteristics of hamstring graft in our subset of patients in Asian population context.

Detailed Description
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This will be a prospective, randomized interventional study conducted at the National University Hospital under University Orthopaedics and Hand surgery Cluster during the period of December 2015 to December 2018. Study participants: The study will include 80 patients with complete Anterior Cruciate Ligament (ACL) tear undergoing primary arthroscopic reconstruction with ipsilateral hamstring autograft after written informed consent to participate in the study. The subjects will be divided into two groups A) 4-strand hamstring or B) 5-strand hamstring group by block randomization using an online randomization generator (http://www.graphpad.com/quickcalcs). All the subjects will undergo the procedure by otherwise identical technique performed by single surgeon. At 1 and 2 years functional and subjective outcomes will be assessed.

Official Title
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Comparison of Clinical and Functional Outcomes at 2 Years of 4-strand Versus 5-strand Hamstring Autograft in Anterior Cruciate Ligament (ACL) Reconstruction: A Prospective Randomized Controlled Trial

Conditions
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Physical Activity

Intervention / Treatment
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* Procedure: Strands of Hamstring Autograft in ACL reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above 18 years Clinical and MRI confirmed complete ACL tear Ipsilateral hamstring autograft Concomitant meniscus injury requiring either meniscus repair or partial menisectomy Concomitant chondral injury Grade 0,1,2 (International Cartilage Repair Society) Regular scheduled follow up with adherence to prescribed rehab protocol Exclusion Criteria: Non consent Paediatric patient; age less than 18 years Partial or incomplete ACL tear Revision ACL surgery Hamstring allograft Multi-ligament injury of the knee (ACL and/or Posterior Cruciate Ligament, Medial Collateral Ligament, Lateral Collateral Ligament, Postero Lateral Corner) Past history of knee surgery Contra-lateral ACL injury or other ligament injury Chondral injury Grade 3,4 (International Cartilage Repair Society) Intra-articular fracture (past or current) Radiologically evident osteoarthritis changes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 4 strand hamstring ACL reconstruction<br>The hamstring tendons will be harvested by standard technique and the lengths of the Semitendinosus and Gracilis tendons will be measured after clearing all adherent muscle tissue. The ends will be prepared and folded in middle to prepare4-strand graft. | Procedure: Strands of Hamstring Autograft in ACL reconstruction<br>* The femoral and tibial ends will be tubularised and the final graft diameter will be recorded after passing through sizing cylinders graduated in 0.5mm increments. The femoral and tibial tunnels will be drilled as per standard technique for single bundle ACL reconstruction via trans-portal or trans-tibial route and both ends fixed by interference screw with additional post on the tibial end.<br>|
| Active Comparator: 5 strand hamstring ACL reconstruction<br>The hamstring tendons will be harvested by standard technique and the lengths of the Semitendinosus (ST) and Gracilis (GR) tendons will be measured after clearing all adherent muscle tissue. For 5-strand graft, minimum length of ST and GR in consideration would be 24 cm and 16 cm respectively. For 5-strand group the ST tendon will be be folded twice and sutured on itself to make a three strand graft and then GR tendon will be folded once along with it to make a final 5-strand graft. | Procedure: Strands of Hamstring Autograft in ACL reconstruction<br>* The femoral and tibial ends will be tubularised and the final graft diameter will be recorded after passing through sizing cylinders graduated in 0.5mm increments. The femoral and tibial tunnels will be drilled as per standard technique for single bundle ACL reconstruction via trans-portal or trans-tibial route and both ends fixed by interference screw with additional post on the tibial end.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport/Rec Score (Function in Sport and Recreation) change from baseline | Patient reported outcome | Baseline, 1 year and 2 years post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tegner-Lysholm Score change from baseline | Patient reported outcome | Baseline, 1 year and 2 years post op | 
| International Knee Documentation Committee (IKDC) Grade change from baseline | Patient reported outcome | Baseline, 1 year and 2 years post op | 
| KOOS Pain change from baseline | Patient reported outcome | Baseline, 1 year and 2 years post op | 
| KOOS Symptoms change from baseline | Patient reported outcome | Baseline, 1 year and 2 years post op | 
| KOOS Function in daily living (KOOS ADL) change from baseline | Patient reported outcome | Baseline, 1 year and 2 years post op | 
| KOOS Knee-related Quality of Life (KOOS QOL) change from baseline | Patient reported outcome | Baseline, 1 year and 2 years post op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL