Physical Activity
Conditions
Keywords
ACL
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.
Interventions
PROCEDUREStrands of Hamstring Autograft in ACL reconstruction
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.
Sponsors
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| International Knee Documentation Committee (IKDC) Grade change from baseline | Baseline, 1 year and 2 years post op | Patient reported outcome |
| KOOS Pain 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 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 |
| KOOS Symptoms change from baseline | Baseline, 1 year and 2 years post op | Patient reported outcome |
Countries
Singapore
Contacts
Primary ContactLingaraj Krishna, FRCS (Orth)
Backup ContactAmritpal Singh, MBBS
Outcome results
None listed