Clinical and Functional Outcomes at 2 Years of 4-strand Versus 5-strand Hamstring Autograft in Anterior Cruciate Ligament Reconstruction
- Conditions
- Physical Activity
- Interventions
- Procedure: Strands of Hamstring Autograft in ACL reconstruction
- Registration Number
- NCT03171532
- Lead Sponsor
- National University Hospital, Singapore
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5 strand hamstring ACL reconstruction Strands of Hamstring Autograft in ACL reconstruction 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. 4 strand hamstring ACL reconstruction Strands of Hamstring Autograft in ACL reconstruction 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.
- Primary Outcome Measures
Name Time Method Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport/Rec Score (Function in Sport and Recreation) change from baseline Baseline, 1 year and 2 years post op Patient reported outcome
- Secondary Outcome Measures
Name Time Method KOOS Pain change from baseline Baseline, 1 year and 2 years post op Patient reported outcome
International Knee Documentation Committee (IKDC) Grade change from baseline Baseline, 1 year and 2 years post op Patient reported outcome
Tegner-Lysholm Score change from baseline Baseline, 1 year and 2 years post op Patient reported outcome
KOOS Symptoms change from baseline Baseline, 1 year and 2 years post op Patient reported outcome
KOOS Function in daily living (KOOS ADL) change from baseline Baseline, 1 year and 2 years post op Patient reported outcome
KOOS Knee-related Quality of Life (KOOS QOL) change from baseline Baseline, 1 year and 2 years post op Patient reported outcome
Trial Locations
- Locations (1)
National University Health System
🇸🇬Singapore, Singapore