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

Physical Activity Clinical Trial

Official title:

Comparison of Clinical and Functional Outcomes at 2 Years of 4-strand Versus 5-strand Hamstring Autograft in Anterior Cruciate Ligament (ACL) Reconstruction: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03171532
• Other study ID #: 2015/00652
• Status: Recruiting
• Phase: N/A
• First received: February 9, 2017
• Last updated: May 28, 2017
• Start date: December 1, 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2017
• Source: National University Hospital, Singapore
• Contact: Lingaraj Krishna, FRCS (Orth)
• Phone: +6567795555
• Email: lingaraj_krishna[@]nuhs.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
Singapore	National University Health System	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tegner-Lysholm Score change from baseline	Patient reported outcome	Baseline, 1 year and 2 years post op
Secondary	International Knee Documentation Committee (IKDC) Grade change from baseline	Patient reported outcome	Baseline, 1 year and 2 years post op
Secondary	KOOS Pain change from baseline	Patient reported outcome	Baseline, 1 year and 2 years post op
Secondary	KOOS Symptoms change from baseline	Patient reported outcome	Baseline, 1 year and 2 years post op
Secondary	KOOS Function in daily living (KOOS ADL) change from baseline	Patient reported outcome	Baseline, 1 year and 2 years post op
Secondary	KOOS Knee-related Quality of Life (KOOS QOL) change from baseline	Patient reported outcome	Baseline, 1 year and 2 years post op