Clinical and Functional Outcomes at 2 Years of 4-strand Versus 5-strand Hamstring Autograft in Anterior Cruciate Ligament Reconstruction

National University Health System (NUHS)

Status: Unknown

Conditions: Physical Activity

Treatments: Procedure: Strands of Hamstring Autograft in ACL reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT03171532

2015/00652

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

4 strand hamstring ACL reconstruction

Active Comparator group

Description:

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.

Treatment:

Procedure: Strands of Hamstring Autograft in ACL reconstruction

5 strand hamstring ACL reconstruction

Active Comparator group

Description:

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.

Treatment:

Procedure: Strands of Hamstring Autograft in ACL reconstruction