An interventional study of Soft tissue hamstring autograft and Quadriceps tendon autograft in ACL - Anterior Cruciate Ligament Rupture, sponsored by McMaster University. Recruiting at 6 sites in 2 countries. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by McMaster University · Not applicable, Interventional, and Treatment
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Among 18 studies in Anterior Cruciate Ligament Injuries with a site in Canada — 3 open to participants now, 6 under way, none of them phase 3. Anterior Cruciate Ligament Injuries · Canada.
Among the 18 studies in Anterior Cruciate Ligament Injuries with a site in Canada, this one is the 3rd largest by planned enrollment of the 16 interventional ones that give a count, is one of 3 that started in 2020, is one of 14 with no phase, and was the 12th registered.
625 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 192 are open to participants now.
Browse Anterior Cruciate Ligament Injuries studies →3 of the 18 studies in Anterior Cruciate Ligament Injuries with a site in Canada are open now. Recruiting first, the newest first:
University of British Columbia · Sites in Canada
Ages 16–35
Western University, Canada · Sites in Canada, United Kingdom
Ages 14–25
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 122 Anterior Cruciate Ligament Injuries studies recruiting now, 27 (22%) set no upper age limit and 92 (75%) stop at 75 or younger; 46 take children under 18; 21 take healthy volunteers.
This study: 10 Years to 18 Years · all sexes · no healthy volunteers.
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18 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 3 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 352 is above the median of 56 across 458 interventional studies indexed under Anterior Cruciate Ligament Injuries.
Median enrollment 59 across the 16 interventional studies, 637 across the 2 observational. Of the 9 that completed or were terminated, 1 (11%) have results posted.
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None of the 18 has an industry lead sponsor. The 10 most frequent:
McMaster University is the lead sponsor of 741 studies on the registry; 127 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
McMaster University has 1 study filed under Anterior Cruciate Ligament Injuries — fewer than ten, so there is no comparison to draw.
2 of the studies in Anterior Cruciate Ligament Injuries with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06195423University of British ColumbiaStopping OsteoARthritis After an ACL Tear | 2026-12-30 |
| NCT06885372Western University, CanadaLong-term Follow up of the Stability 1 Trial | 2027-03 |
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Among the 18 studies in Anterior Cruciate Ligament Injuries with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
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To date, the use of the quadriceps tendon as an autograft option in primary paediatric Anterior Cruciate Ligament (ACL) reconstruction has not been well studied. The 2018 International Olympic Committee (IOC) Consensus Statement now outlines the quadriceps tendon as a possible autograft option. However, no Randomised Control Trial (RCT) has examined the efficacy of the quadriceps tendon autograft in primary paediatric ACL reconstruction compared to the historical "gold-standard" soft-tissue hamstring autograft in this population. In light of its evidence for favourable outcomes in the adult population, and the (albeit limited) evidence showing safety and promise in the paediatric population, clinical equipoise exists for assessing its impact on outcomes in paediatric patients at the index surgery. This is a parallel, international, multi-centre, blinded randomized controlled trial of 352 skeletally-immature (at the time of injury) patients (ages 10-18 years, inclusive) undergoing primary ACL reconstruction to compare the effect of autograft tendon choice (i.e. hamstring versus soft-tissue quadriceps) on the rates of ACL graft failure, return-to-sport, knee function, pain, health-related quality of life and health utility, psychological factors, range of motion and stability, and any other adverse events at 24 months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients in the study will undergo arthroscopic-assisted, single-bundle, complete transphyseal, anatomic primary ACL reconstruction at the discretion of the surgeon, considering the individual patient's age, physeal status, and anticipated years of growth remaining to skeletal maturity. Patients in this arm will undergo soft-tissue autograft reconstruction using hamstrings (i.e. semitendinosus and/or gracilis) grafts. Grafts will be secured on the femur and tibia according to surgeon preference, given literature demonstrating no clear superior method for graft fixation.
Procedure: Soft tissue hamstring autograft
Patients in this arm will undergo soft-tissue autograft reconstruction using all-soft-tissue quadriceps (i.e. full or partial thickness) grafts. Grafts will be secured on the femur and tibia according to surgeon preference, given literature demonstrating no clear superior method for graft fixation.
Procedure: Quadriceps tendon autograft
Patients will be prescribed to receive a soft tissue hamstring autograft to for ACL reconstruction.
Patients will be prescribed to receive a quadriceps tendon autograft to for ACL reconstruction.
Rate of ACL failure
ACL graft failure is a composite outcome defined by MRI confirmation of rupture and/or asymmetrical symptomatic laxity (i.e., positive Lachman and/or positive pivot shift).
Time frame: 2 years
Rate of Return to Sport
Return to sport (at any level and to pre-injury level) will be evaluated using the Tegner Activity Scale. The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports, in which the response is presented as an 11-point Likert scale, where 0 indicates the lowest level of ability to perform work and sport functions, and 10 indicates competitive participation in high level sports.
Time frame: 2 years
Patient Reported Knee Function
Patient Knee Function will be evaluated using the Pediatric International Knee Documentation Committee Subjective Form (Pedi-IKDC). The Pedi-IKDC is a 15 question form that consists of measures of daily living and sport activity, in which the response options are presented as either 4 or 10 point Likert scales. Scores for the form range from 0 (lowest level of function) to 100 (highest level of function).
Time frame: 2 years
Knee Pain
Knee pain will be evaluated using a 100-point Visual Analogue Scale (VAS). The VAS has been validated in ACL patients and is one of the most commonly used pain rating scores both in research and clinical practice as it is an easy-to-use, validated, one-dimensional scale that does not require verbal or reading skills.
Time frame: 2 years
Health-Related Quality of Life
Health-related quality of life (HRQL) and health utility will be evaluated using the EuroQol 5 Dimensions for Youth (EQ-5D-Y-3L) questionnaire.The EQ-5D is a standardized, utility-based instrument for use as a measure of HRQL and health utility. Similar to the adult version, the EQ-5D-Y-3L comprises 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/ depression. The EQ-5D-Y-3L has been extensively validated in international paediatric populations.
Time frame: 2 years
Psychological Readiness to Return-to-Sport
Psychological predictors, specifically psychological readiness to return-to-sport, will be evaluated using the Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) questionnaire, which has been shown to be reliable and responsive at the group (study) level in younger populations across all sexes. The ACL-RSI scale has 3 domains: risk appraisal, confidence, and emotions. Greater psychological preparation is indicated by higher scores.
Time frame: 2 years
Range of Motion
Knee range of motion (ROM) and both anterior-posterior and rotational stability will be evaluated through physical examination (i.e. Lachman and pivot shift tests, respectively). ROM will be measured in the flexion-extension (i.e. sagittal) plane using a goniometer. Anterior-posterior stability will be measured using the Lachman test, given its non-invasive nature, high sensitivity, superiority over the anterior drawer test, and by virtue of being the most reliable clinical method to assess ACL integrity. It will be performed in the supine position, with the extremity in 20-30° of knee flexion, as is commonly described. Similarly, rotational stability will be assessed using the standardized pivot shift test, performed in 30° of knee flexion.
Time frame: 2 years
Adverse Events
The expert Adjudication Committee will evaluate all graft failures, re-operations and other knee-related adverse events through a process of independent review and consensus, guided by decision rules detailed in the Adjudication Charter (drafted using recommendations from the literature, tested for validity and agreement among the adjudicators, and in use for the pilot study). An adverse event is defined as any symptom, sign, illness, or experience that develops or worsens in severity during the course of the trial.
Time frame: 2 years
Plan to share: No
Started Jan 2020 (actual). Primary completion is estimated for Jan 2030, 120 months after the start.
Of 278 non-industry interventional studies with no phase under Anterior Cruciate Ligament Injuries, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 70. This study's planned 120 months is above that.
Counting every sponsor, half of 287 studies reached it within 30 months; a quarter within 14 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Anterior Cruciate Ligament Injuries →