NCT02018354

Brief Summary

The purpose of this study is to compare outcomes (failure, function, strength, range of motion and quality of life) between patients who receive the usual anterior cruciate ligament (ACL) reconstructive surgery and patients who receive anterior cruciate ligament reconstructive surgery with a lateral extra-articular tenodesis (extra tendon repair on the outside of the knee). Some studies have shown high graft failure rates (ACL re-tear) in young individuals who return to pivoting contact sports following ACL reconstruction. This study is designed to look at whether or not adding this extra tendon repair reduces the risk of graft failure in this population.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
624

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
3 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 23, 2013

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

11.2 years

First QC Date

December 2, 2013

Last Update Submit

January 4, 2024

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

OrthopaedicsAnterior cruciate ligament (ACL) reconstructionAnterolateral ligamentLateral Extra-articular Tenodesis (LET)

Outcome Measures

Primary Outcomes (1)

  • Graft Failure

    * symptomatic instability requiring revision ACL surgery * positive pivot shift or asymmetrical pivot shift greater than other contralateral side We will determine the absolute risk of graft failure in each group, calculate a relative risk (RR) and risk difference (RD) of graft failure with 95% confidence intervals around the estimate and use a Mantel Haentzel Test (random effect of surgeon) to determine the significance of the association between the addition of LET and graft failure rates. We will calculate the number needed to treat (NNT) to describe the number of patients who need to receive LET to prevent one graft failure over the first two postoperative years.

    24 months

Secondary Outcomes (7)

  • Disease-specific quality of life using the ACL Quality of Life Questionnaire (ACL-QOL)

    Baseline, 3, 6, 12, 24 months

  • Region-specific quality of life using the Knee Osteoarthritis and outcomes Score (KOOS).

    Baseline, 3, 6, 12, 24 months

  • MARX Activity Rating Scale

    Baseline, 3, 6, 12, 24 months

  • Passive knee extension and active-assisted knee flexion

    Baseline, 3, 6, 12, 24 months

  • Quality-adjusted life years (QALYs) using the European Quality of Life Scale (Euro-QoL)

    Baseline, 3, 6, 12, 24 months

  • +2 more secondary outcomes

Study Arms (2)

ACL Reconstruction

ACTIVE COMPARATOR

Standard ACL reconstruction only.

Procedure: ACL Reconstruction

ACL + LET

EXPERIMENTAL

Anatomic ACL reconstruction following the same procedure as the active comparator group with an added lateral extra-articular tenodesis (LET).

Procedure: Lateral Extra-Articular Tenodesis (LET)Procedure: ACL Reconstruction

Interventions

Lateral Extra-Articular Tenodesis (LET)PROCEDURE

Lateral extra-articular tenodesis: A 1cm wide x 8cm long strip of iliotibial band is fashioned, leaving the Gerdys tubercle attachment intact. The graft is tunneled under the fibular collateral ligament (FCL) and attached to the femur with a Richards' staple (Smith \& Nephew), just distal to the intermuscular septum, proximal to the femoral insertion of the FCL. Fixation is performed with the knee at 70 degrees flexion, neutral rotation. Minimal tension is applied to the graft. The free end is then looped back onto itself and sutured using the No. 1 vicryl.

ACL + LET
ACL ReconstructionPROCEDURE

Anatomic ACL reconstruction using a four-strand autologous hamstring graft. If the diameter of the graft is found to be less than 7.5mm, semitendinosus will be tripled (5 strand graft) providing a greater graft diameter. Femoral tunnels will be drilled using an anteromedial portal technique, with femoral fixation provided by an Endobutton or equivalent. Tibial fixation will be provided by interference screw.

ACL + LETACL Reconstruction

Eligibility Criteria

Age14 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ACL deficient knee
  • skeletally mature to 25 years of age
  • or more of:
  • competitive pivoting sport
  • grade 2 pivot shift or greater
  • generalized ligament laxity - Beighton score of 4 or greater

You may not qualify if:

  • previous ACL reconstruction on either knee
  • multi-ligament injury (two or more ligaments requiring surgical attention)
  • symptomatic articular cartilage defect requiring treatment other than debridement
  • greater than 3 degrees of asymmetric varus
  • unable to complete outcome questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Antwerp Orthopedic Center

Antwerp, 2018, Belgium

Location

Banff Sport Medicine Clinic

Banff, Alberta, T1L 1B3, Canada

Location

Fraser Health Authority

New Westminster, British Columbia, V3L 5P5, Canada

Location

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

Location

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Queen's University

Kingston, Ontario, K7L 2V7, Canada

Location

Fowler Kennedy Sport Medicine Clinic

London, Ontario, N6A 3K7, Canada

Location

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, CV2 2DX, United Kingdom

Location

Related Publications (5)

  • Nakanishi Y, Hegarty P, Vivacqua T, Firth A, Milner JS, Pritchett S, Willits K, Litchfield R, Bryant D, Getgood AMJ. Quantitative MRI Analysis of Patellofemoral Joint Cartilage Health 2 Years After Anterior Cruciate Ligament Reconstruction and Lateral Extra-Articular Tenodesis. Am J Sports Med. 2024 Jun;52(7):1773-1783. doi: 10.1177/03635465241248642. Epub 2024 May 25.

    PMID: 38794906DERIVED

  • Marmura H, Tremblay PF, Getgood AMJ, Bryant DM. A bifactor model supports unidimensionality of the International Knee Documentation Committee Subjective Knee Form in young active patients with anterior cruciate ligament tears: a retrospective analysis of a randomized controlled trial. Health Qual Life Outcomes. 2023 Sep 12;21(1):104. doi: 10.1186/s12955-023-02186-y.

    PMID: 37697331DERIVED

  • Marmura H, Getgood AMJ, Spindler KP, Kattan MW, Briskin I, Bryant DM. Validation of a Risk Calculator to Personalize Graft Choice and Reduce Rupture Rates for Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2021 Jun;49(7):1777-1785. doi: 10.1177/03635465211010798. Epub 2021 May 4.

    PMID: 33945339DERIVED

  • Getgood AMJ, Bryant DM, Litchfield R, Heard M, McCormack RG, Rezansoff A, Peterson D, Bardana D, MacDonald PB, Verdonk PCM, Spalding T; STABILITY Study Group; Willits K, Birmingham T, Hewison C, Wanlin S, Firth A, Pinto R, Martindale A, O'Neill L, Jennings M, Daniluk M, Boyer D, Zomar M, Moon K, Pritchett R, Payne K, Fan B, Mohan B, Buchko GM, Hiemstra LA, Kerslake S, Tynedal J, Stranges G, Mcrae S, Gullett L, Brown H, Legary A, Longo A, Christian M, Ferguson C, Mohtadi N, Barber R, Chan D, Campbell C, Garven A, Pulsifer K, Mayer M, Simunovic N, Duong A, Robinson D, Levy D, Skelly M, Shanmugaraj A, Howells F, Tough M, Spalding T, Thompson P, Metcalfe A, Asplin L, Dube A, Clarkson L, Brown J, Bolsover A, Bradshaw C, Belgrove L, Millan F, Turner S, Verdugo S, Lowe J, Dunne D, McGowan K, Suddens CM, Declercq G, Vuylsteke K, Van Haver M. Lateral Extra-articular Tenodesis Reduces Failure of Hamstring Tendon Autograft Anterior Cruciate Ligament Reconstruction: 2-Year Outcomes From the STABILITY Study Randomized Clinical Trial. Am J Sports Med. 2020 Feb;48(2):285-297. doi: 10.1177/0363546519896333. Epub 2020 Jan 15.

    PMID: 31940222DERIVED

  • Getgood A, Bryant D, Firth A; Stability Group. The Stability study: a protocol for a multicenter randomized clinical trial comparing anterior cruciate ligament reconstruction with and without Lateral Extra-articular Tenodesis in individuals who are at high risk of graft failure. BMC Musculoskelet Disord. 2019 May 15;20(1):216. doi: 10.1186/s12891-019-2589-x.

    PMID: 31092226DERIVED

Study Officials

  • Alan Getgood, MD

    University of Western Ontario, Canada

    PRINCIPAL INVESTIGATOR

  • Dianne Bryant, Phd

    University of Western Ontario, Canada

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 2, 2013

First Posted

December 23, 2013

Study Start

January 1, 2014

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

January 8, 2024

Record last verified: 2024-01

Locations

CA(6)BE(1)GB(1)