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

NCT03171532 | Unknown DMC

• 1 other identifier: 2015/00652
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity

Keywords

ACL

Outcome Measures

Primary Outcomes (1)

• Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport/Rec Score (Function in Sport and Recreation) change from baseline

  Patient reported outcome

  Baseline, 1 year and 2 years post op

Secondary Outcomes (6)

• Tegner-Lysholm Score change from baseline

  Baseline, 1 year and 2 years post op

• International Knee Documentation Committee (IKDC) Grade change from baseline

  Baseline, 1 year and 2 years post op

• KOOS Pain change from baseline

  Baseline, 1 year and 2 years post op

• KOOS Symptoms change from baseline

  Baseline, 1 year and 2 years post op

• KOOS Function in daily living (KOOS ADL) change from baseline

  Baseline, 1 year and 2 years post op

Study Arms (2)

4 strand hamstring ACL reconstruction

ACTIVE COMPARATOR

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

5 strand hamstring ACL reconstruction

ACTIVE COMPARATOR

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

Interventions

Strands of Hamstring Autograft in ACL reconstruction PROCEDURE

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.

4 strand hamstring ACL reconstruction; 5 strand hamstring ACL reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Health System

Singapore, 119074, Singapore

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Lingaraj Krishna, FRCS (Orth)

  National University Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingaraj Krishna, FRCS (Orth)

CONTACT

+6567795555; lingaraj_krishna@nuhs.edu.sg

Amritpal Singh, MBBS

CONTACT

+6567795555; amritpal_singh@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: May 31, 2017
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 31, 2018
• Last Updated: May 31, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)