An interventional study of Strands of Hamstring Autograft in ACL reconstruction in Physical Activity, sponsored by National University Hospital, Singapore. Status unknown at 1 site in Singapore. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-31.
Sponsored by National University Hospital, Singapore · Not applicable, Interventional, and Treatment
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.
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.
National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.
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Exclusion Criteria:
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
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
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.
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport/Rec Score (Function in Sport and Recreation) change from baseline
Patient reported outcome
Time frame: Baseline, 1 year and 2 years post op
Tegner-Lysholm Score change from baseline
Patient reported outcome
Time frame: Baseline, 1 year and 2 years post op
International Knee Documentation Committee (IKDC) Grade change from baseline
Patient reported outcome
Time frame: Baseline, 1 year and 2 years post op
KOOS Pain change from baseline
Patient reported outcome
Time frame: Baseline, 1 year and 2 years post op
KOOS Symptoms change from baseline
Patient reported outcome
Time frame: Baseline, 1 year and 2 years post op
KOOS Function in daily living (KOOS ADL) change from baseline
Patient reported outcome
Time frame: Baseline, 1 year and 2 years post op
KOOS Knee-related Quality of Life (KOOS QOL) change from baseline
Patient reported outcome
Time frame: Baseline, 1 year and 2 years post op
Plan to share: No
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This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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National University Hospital, Singapore