Clinical and Functional Outcomes at 2 Years of 4-strand Versus 5-strand Hamstring Autograft in Anterior Cruciate Ligament Reconstruction
NCT ID: NCT03171532
Last Updated: 2017-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2015-12-01
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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4 strand hamstring 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.
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.
5 strand hamstring 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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National University Hospital, Singapore
OTHER
Responsible Party
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Principal Investigators
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Lingaraj Krishna, FRCS (Orth)
Role: PRINCIPAL_INVESTIGATOR
National University Health System
Locations
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National University Health System
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Lingaraj Krishna, FRCS (Orth)
Role: primary
Amritpal Singh, MBBS
Role: backup
Other Identifiers
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2015/00652
Identifier Type: -
Identifier Source: org_study_id