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Anterior Cruciate Ligament ReconstructionSTAbiLiTYNCT02018354

Standard ACL Reconstruction vs ACL + Lateral Extra-Articular Tenodesis Study

A study testing Lateral Extra-Articular Tenodesis (LET) and ACL Reconstruction in people with Anterior Cruciate Ligament Reconstruction, run by University of Western Ontario, Canada at 8 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 14 to 25 years
What is being tested?
Lateral Extra-Articular Tenodesis (LET) and ACL Reconstruction
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
624 participants
Where
8 sitesin 3 countries
Study dates
Jan 2014to Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

Canada6 sites

  • Banff Sport Medicine Clinic

    Banff, Alberta, T1L 1B3

  • McMaster University

    Hamilton, Ontario, L8N 3Z5

  • Queen's University

    Kingston, Ontario, K7L 2V7

  • Fowler Kennedy Sport Medicine Clinic

    London, Ontario, N6A 3K7

  • Fraser Health Authority

    New Westminster, British Columbia, V3L 5P5

  • Pan Am Clinic

    Winnipeg, Manitoba, R3M 3E4

Other trials in Canada

Belgium1 site

  • Antwerp Orthopedic Center

    Antwerp, 2018

Other trials in Belgium

United Kingdom1 site

  • University Hospitals Coventry and Warwickshire NHS Trust

    Coventry, CV2 2DX

Other trials in United Kingdom

About this study

Official title: 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.

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.

Read the detailed description

This study is a pragmatic study for a parallel groups, randomized clinical trial in which 600 patients with anterior cruciate ligament insufficiency who are undergoing surgery, are randomly allocated to either ACL reconstruction alone (control) or ACL reconstruction with lateral extra-articular tenodesis (experimental). Surgeons, data collectors, and the data analyst will be blind to group allocation. The primary outcome is rate of failure. Secondary outcomes include disease specific quality of life, return to function and sport. Patients are followed for two years postoperative.

Being tested
Lateral Extra-Articular Tenodesis (LET), ACL Reconstruction
Keywords
Orthopaedics, Anterior cruciate ligament (ACL) reconstruction, Anterolateral ligament, Lateral Extra-articular Tenodesis (LET)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lateral Extra-Articular Tenodesis (LET)Procedure or surgery

    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 ReconstructionProcedure or surgery

    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.

Study groups in NCT02018354
Study groupRoleWhat they receive
ACL ReconstructionActive comparatorStandard ACL reconstruction only.
Receives: Procedure: ACL Reconstruction
ACL + LETExperimentalAnatomic ACL reconstruction following the same procedure as the active comparator group with an added lateral extra-articular tenodesis (LET).
Receives: Procedure: Lateral Extra-Articular Tenodesis (LET); Procedure: ACL Reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months

Secondary outcomes (7)

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

    The ACL-QOL has five domains that query physical symptoms, occupational concerns, recreational activities, lifestyle, and social and emotional aspects. Each item has one 100 mm visual analogue scale response option, with labeled anchors at 0 mm (e.g., extremely difficult) and 100 mm (e.g., not difficult at all). Scores are calculated by converting the average of each of the five domain scores to a total average score out of 100% where 100% represents the best possible score.

    Measured: Baseline, 3, 6, 12, 24 months

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

    The KOOS is a 42-item knee-specific questionnaire with five separately reported domains, including pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sports/recreation (5 items) and knee-related quality of life (4 items). Domain scores represent the average of all items in the domain standardized to a score from 0 to 100 (worst to best). This instrument has face validity and has demonstrated construct validity, excellent test-retest reliability for each domain (range, 0.75 to 0.93) and has been shown to be responsive to change in patients with knee OA and following HTO surgery.

    Measured: Baseline, 3, 6, 12, 24 months

  3. MARX Activity Rating Scale

    The MARX Activity Rating Scale is a four-item activity rating scale. The patient is asked to rate how often they were able to perform each activity (e.g. running, cutting, decelerating, and pivoting) in their most healthy and active state. The patient is provided with five categories of frequency of each functional activity, ranging from less than one time in a month to four or more times in a week. One point is allocated for each category of frequency and a maximum score of 16 points can be awarded.

    Measured: Baseline, 3, 6, 12, 24 months

  4. Passive knee extension and active-assisted knee flexion

    For passive knee extension, the patient is seated with both legs extended on a table, heel propped so that the calf and upper thigh clear treatment table. The patient will be instructed to relax both quadriceps and hamstrings to assure passive measurement. For active-assisted knee flexion, the patient is seated with both legs extended on a table. They will be instructed to perform active-assisted knee flexion by placing one hand under their thigh to initiate flexion and then clasp both hands just below the tibial tuberosity. This is measured as distance in centimeters of heel lift from the couch in passive hyperextension, and distance in centimeters of heel to buttock in flexion, both compared to the uninvolved side.

    Measured: Baseline, 3, 6, 12, 24 months

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

    The EuroQoL comprises two sections, the EQ-5D index and the EQ-5D visual analogue scale (VAS). The EQ-5D index is a 5 item standardized generic measure of HRQOL that includes domains of mobility, self-care, usual activities, pain and discomfort and anxiety and depression. Each item is score using a 3 point response scale and each combination of response choices describes a health state (243 unique health states). Each health state can be converted to a utility value from 0 (worst) to 1.0 (best) using a scoring formula. The EQ-5D VAS is a 0 (worst) to 100 (best) scale that assesses patient-perceived health status. The EQ-5D index and VAS have demonstrated good test retest reliability (0.73 and 0.70 respectively) and good cross-sectional construct validity in patients with rheumatoid arthritis and those with osteoarthritis of the knee, and is able to discriminate between functional classes in patients with arthritis.

    Measured: Baseline, 3, 6, 12, 24 months

  6. Radiographic evidence of osteoarthritis

    Radiographic Evidence of osteoarthritis will also be evaluated with plain antero-posterior, Rosenberg and lateral view radiographs at 1 and 2 years.

    Measured: Baseline, 12, 24 months

  7. Subjective symptoms, function and activity.

    The International Knee Documentation Committee (IKDC) Subjective Knee Form is an 18-item region specific, patient-important questionnaire containing the domains of symptoms, function and sports activities. The instrument measures subjective pain, stiffness and swelling, joint locking and instability. Function is assessed through comparing current knee function with knee function prior to injury. It evaluates sports activities based on ability to run, jump and land, stop and start quickly, ascend and descend stairs, stand, kneel on the front of the knee, squat, sit with the knee bent, and rise from a chair. Response types include 5-point Likert scales, 11-point Likert scales and dichotomous "yes or no" responses. The IKDC has been proven to be a valid and reliable instrument for patients suffering from knee injury and disability.

    Measured: Baseline, 3, 6, 12, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionMar 2025 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
624 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02018354
Sponsor's protocol ID
REB# 104524
Acronym
STAbiLiTY
Status last verified
Jan 2024
First submitted
2 Dec 2013
Last updated
8 Jan 2024
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 38794906

  • 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.

    PubMed 37697331

  • 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.

    PubMed 33945339

  • 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.

    PubMed 31940222

  • 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.

    PubMed 31092226

Questions about this trial

What is this clinical trial studying?

A study testing Lateral Extra-Articular Tenodesis (LET) and ACL Reconstruction in people with Anterior Cruciate Ligament Reconstruction, run by University of Western Ontario, Canada at 8 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Canada, Belgium, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Graft Failure (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02018354, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024; AzTrials last refreshed its copy on 30 Oct 2026.

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