Clinical trial NCT03171532: Clinical and Functional Outcomes at 2 Years of 4-strand Versus 5-strand Hamstring Autograft in Anterior Cruciate Ligament Reconstruction
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Activity
Keywords: ACL
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age above 18 years
2. Clinical and MRI confirmed complete ACL tear
3. Ipsilateral hamstring autograft
4. Concomitant meniscus injury requiring either meniscus repair or partial menisectomy
5. Concomitant chondral injury Grade 0,1,2 (International Cartilage Repair Society)
6. Regular scheduled follow up with adherence to prescribed rehab protocol

Exclusion Criteria:

1. Non consent
2. Paediatric patient; age less than 18 years
3. Partial or incomplete ACL tear
4. Revision ACL surgery
5. Hamstring allograft
6. Multi-ligament injury of the knee (ACL and/or Posterior Cruciate Ligament, Medial Collateral Ligament, Lateral Collateral Ligament, Postero Lateral Corner)
7. Past history of knee surgery
8. Contra-lateral ACL injury or other ligament injury
9. Chondral injury Grade 3,4 (International Cartilage Repair Society)
10. Intra-articular fracture (past or current)
11. Radiologically evident osteoarthritis changes

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport/Rec Score (Function in Sport and Recreation) change from baseline
timeFrame: Baseline, 1 year and 2 years post op
Secondary outcomes:
measure: Tegner-Lysholm Score change from baseline
timeFrame: Baseline, 1 year and 2 years post op
measure: International Knee Documentation Committee (IKDC) Grade change from baseline
timeFrame: Baseline, 1 year and 2 years post op
measure: KOOS Pain change from baseline
timeFrame: Baseline, 1 year and 2 years post op
measure: KOOS Symptoms change from baseline
timeFrame: Baseline, 1 year and 2 years post op
measure: KOOS Function in daily living (KOOS ADL) change from baseline
timeFrame: Baseline, 1 year and 2 years post op
measure: KOOS Knee-related Quality of Life (KOOS QOL) change from baseline
timeFrame: Baseline, 1 year and 2 years post op
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Health System
Study officials:
affiliation: National University Health System
name: Lingaraj Krishna, FRCS (Orth)
role: PRINCIPAL_INVESTIGATOR
References: