2017 ISAKOS Biennial Congress Paper #175

Anterior Cruciate Ligament Reconstruction With or Without a Lateral Extra-Articular Tenodesis – Assessment of Failure at One Year from the ISAKOS Sponsored Stability Study

Alan Getgood, MD, FRCS(Tr&Orth), DipSEM, London, ON CANADA
Robert Litchfield, MD, FRCSC, London, ON CANADA
Christopher Hewison, BSc, London, ON CANADA
Dianne M. Bryant, PhD, London, ON CANADA
Robert G. McCormack, MD, New Westminster, BC CANADA
Mark A. Heard, MD, FRCS, Canmore, AB CANADA
Peter B. Macdonald, MD, FRCS, Dip Sport Med, Winnipeg, MB CANADA
Tim Spalding, FRCS(Orth), Coventry, West Midlands UNITED KINGDOM
Peter Verdonk, MD, PhD, Zwijnaarde BELGIUM
Devin Peterson, London, ON CANADA
Davide Bardana, MD, Kingston, ON CANADA
Alex Rezansoff, MD, FRCSC, Calgary, AB CANADA

Fowler Kennedy Sport Medicine Clinic, University of Western Ontario, London, Ontario, CANADA

FDA Status Not Applicable

Summary

This multicenter randomized clinical trial has compared rotational stability following ACL reconstruction with or without lateral extra-articular tenodesis with the aim of reducing risk of graft failure and persistent anterolateral rotatory laxity. One year primary and secondary outcome data will be available for presentation from this ISAKOS sponsored study at in June 2017.

Abstract

Introduction

Persistent anterolateral rotatory laxity following anterior cruciate ligament reconstruction (ACLR) has been correlated with poor outcome and graft failure. We hypothesized that anterolateral complex reconstruction by way of a Lateral Extra-articular Tenodesis (LET) in combination with single bundle ACLR would reduce the risk of persistent rotatory laxity in young individuals who are deemed as being at high risk of failure.

Methods

This is an ISAKOS sponsored pragmatic, multicenter, randomized clinical trial comparing standard hamstring tendon ACLR with combined ACLR and LET, utilizing a strip of iliotibial band (Modified Lemaire). Patients aged 25 years or less with an ACL deficient knee were included. They also had to have two of the following three criteria: 1) Grade 2 pivot shift or greater; 2) Returning to high risk/pivoting sports; 3) Generalized ligamentous laxity. The primary outcome measure was graft failure defined as either the need for revision ACLR or symptomatic instability associated with a positive asymmetric pivot shift, indicating persistent rotational laxity. Secondary outcome measures include KOOS, IKDC, ACL-QOL, Marx activity scale and EQ-5D patient reported outcome measures. Patients are followed for two years with visits at 3, 6, 12 and 24 months postoperatively. A sample size of 300 per group was calculated based on a relative reduction in graft failure by 40%, with type 1 error of 5% and 80% power.

Results

To date 510 patients have been randomized with a mean age of 18.9 (range: 14-25). 436 (87.9%) patients presented pre-operatively with high-grade rotatory laxity (grade 2 pivot or greater) and 215 (42.1%) were diagnosed as having generalized ligamentous laxity (Beighton Score of 4 or greater). 328 patients have reached 12 months post operative, the results of which will be available for presentation following unblinding of participants at the close of recruitment which is planned in 1st quarter 2017. The results will therefore be available for presentation at ISAKOS 2017.

Conclusion

One year primary and secondary outcome data will be ready for presentation at ISAKOS 2017 from this important randomized clinical trial investigating the efficacy of the addition of LET to ACLR in patients who are deemed at high risk of graft failure.