Quadriceps vs. Hamstring Autograft for ACL Rupture

(SQuASH Trial)

Recruiting at 6 trial locations

Overseen By Nicole Simunovic, MSc

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Osteoarthritis, Fractures, Previous knee surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Surgery and immediate post-operative period

352 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Quadriceps tendon autograft, Quadriceps tendon autograft, Soft-tissue quadriceps autograft, Soft tissue hamstring autograft, Hamstring tendon autograft, Soft tissue hamstring graft for ACL rupture?

Research shows that both quadriceps and hamstring tendon autografts are effective for ACL reconstruction, with similar clinical and functional outcomes over a 5-year period. Additionally, quadriceps tendon autografts have been found to have a lower re-rupture rate compared to hamstring tendon autografts. ^{1 2 3 4 5}

Is it safe to use quadriceps or hamstring tendon autografts for ACL reconstruction?

Both quadriceps and hamstring tendon autografts are generally considered safe for ACL reconstruction, with similar outcomes and failure rates. The quadriceps tendon autograft is gaining popularity due to its robust nature and lower risk of complications at the donor site. ^{2 3 6 7 8}

How does the quadriceps tendon autograft treatment for ACL rupture differ from other treatments?

The quadriceps tendon autograft is unique because it may result in lower re-rupture rates compared to the hamstring tendon autograft, and it is increasingly popular for adolescents who cannot use grafts with bone plugs. It also offers a different option for those who have had previous ACL reconstructions with other types of grafts. ^{3 4 5 9 10}

Research Team

Darren de SA, MD

Principal Investigator

McMaster University

Eligibility Criteria

This trial is for boys and girls aged 10-18 who have had an ACL injury, speak the clinic's language, and can give informed consent. They must have been active in sports before their injury and be suitable for a specific type of knee surgery. Kids with very flexible joints, significant other health issues, or previous knee surgeries aren't eligible.

Inclusion Criteria

I have had ACL reconstruction with specific drilling techniques.

I am between 10 and 18 years old.

Patient and parent/guardian provide informed consent.

Exclusion Criteria

I have had surgery on my knee or the opposite knee before.

I may find it hard to keep up with follow-up appointments.

My knee damage is confirmed by tests to be Grade 2 or higher.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ACL reconstruction using either soft-tissue quadriceps or hamstring autografts

Surgery and immediate post-operative period

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of knee function and return to sport

2 years

Long-term follow-up

Continued monitoring of knee function and re-operation rates

2 years

Treatment Details

Interventions

• Quadriceps tendon autograft
• Soft tissue hamstring autograft

Trial Overview The study compares two types of tendon grafts used in knee surgery to repair the ACL in kids: one from the hamstring (the current standard) and one from the quadriceps (a newer option). The goal is to see which graft leads to better surgery outcomes like fewer re-operations and improved knee function.

Participant Groups

Group I: Soft-tissue hamstring Active Control 1 Intervention

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.

Group II: Quadriceps tendon Active Control 1 Intervention

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.

Quadriceps tendon autograft is already approved in European Union, United States for the following indications:

Approved in European Union as Quadriceps tendon autograft for:

• Anterior cruciate ligament reconstruction in skeletally immature patients

Approved in United States as Quadriceps tendon autograft for:

• Anterior cruciate ligament reconstruction in pediatric patients

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Canadian Orthopaedic Foundation

Collaborator

Trials

15

Recruited

1,900+

The Physicians' Services Incorporated Foundation

Collaborator

Trials

165

Recruited

31,700+

Findings from Research

In a study of 83 patients undergoing ACL reconstruction, the soft-tissue quadriceps tendon (QT) autograft showed significantly better patient-reported outcomes at 5 years post-surgery compared to the hamstring tendon (HT) autograft, with higher IKDC and Lysholm scores.

Despite the QT autograft's superior scores, both graft types had similar rates of return to sport and postoperative complications, indicating that QT is a safe and effective alternative to HT with comparable long-term results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mid-Term Outcomes of the All-Soft Quadriceps Tendon Autograft Are Noninferior to Hamstring Autograft in Primary Anterior Cruciate Ligament Reconstruction: Comparison With Minimum 5-Year Follow-Up. Brinkman, JC., Tummala, SV., Hassebrock, JD., et al.[2023]

In a study of 34 patients who underwent ACL reconstruction with either quadriceps tendon (QT) or bone-patellar tendon-bone (BTB) autografts, both graft types resulted in similar isometric strength deficits one year post-surgery.

The study found no significant differences in quadriceps muscle firing patterns between the two graft types, suggesting that using QT autografts does not negatively impact muscle function compared to BTB autografts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Neuromuscular Firing Patterns of the Superficial Quadriceps in Soft Tissue Quadriceps Tendon Versus Bone-Patellar Tendon-Bone ACL Autografts. Letter, M., Baraga, MG., Best, TM., et al.[2022]

Adolescents who underwent anterior cruciate ligament reconstruction (ACLR) using quadriceps tendon autograft (ACLR-Q) had significantly smaller hamstring strength deficits compared to those who received hamstring tendon autograft (ACLR-HS), indicating better preservation of hamstring function post-surgery.

While ACLR-Q patients exhibited greater quadriceps strength deficits than ACLR-HS patients, they achieved more favorable hamstring-to-quadriceps (HS:Q) ratios, suggesting a potential advantage in muscle balance that could benefit their return to sports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Return to Sport After ACL Reconstruction With Soft Tissue Autograft in Adolescent Athletes: Quadriceps Versus Hamstring Tendon. Kay, J., Liotta, ES., Sugimoto, D., et al.[2023]

Revision anterior cruciate ligament reconstruction (ACLR) using all-soft tissue quadriceps tendon autografts showed significant improvement in knee function, with IKDC scores rising from 54.3 to 82.8 over an average follow-up of 42.2 months.

The procedure had a reasonable complication rate, with 11 graft failures out of 80 patients followed, and no significant differences in quadriceps strength were observed between patients who previously had hamstring versus patellar tendon autografts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revision Anterior Cruciate Ligament Reconstruction with the All-Soft Tissue Quadriceps Tendon Autograft Has Acceptable Early and Intermediate-Term Outcomes. Hunnicutt, JL., Haynes, WB., Slone, HS., et al.[2021]

In a systematic review of 15 studies involving 1154 patients, quadriceps tendon autografts (QT) showed a significantly lower rate of graft re-rupture (2.5% vs 8.7%) and donor site morbidity (17.6% vs 26.2%) compared to hamstring tendon autografts (HS) for ACL reconstruction.

While QT demonstrated a slight advantage in reducing the positive pivot shift test results, both graft types had similar functional outcomes as measured by the IKDC and Lysholm scores, indicating comparable effectiveness in overall knee function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quadriceps tendon has a lower re-rupture rate than hamstring tendon autograft for anterior cruciate ligament reconstruction - A meta-analysis. Hurley, ET., Mojica, ES., Kanakamedala, AC., et al.[2022]

In a study of 80 patients who underwent ACL reconstruction, there were no significant differences in patient-reported outcomes (PRO) between those who received quadriceps tendon (QT) autografts and those who received hamstring tendon (HT) autografts after 2 years.

Both graft types resulted in comparable functional outcomes, with a high percentage of patients reporting good or excellent results, indicating that QT is a reliable alternative to HT for ACL reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

There is no difference between quadriceps- and hamstring tendon autografts in primary anterior cruciate ligament reconstruction: a 2-year patient-reported outcome study. Runer, A., Wierer, G., Herbst, E., et al.[2022]

Quadriceps tendon (QT) autograft is becoming a popular choice for anterior cruciate ligament (ACL) reconstruction due to its safety and minimal donor-site complications, showing similar outcomes and failure rates compared to traditional grafts like bone-patellar tendon-bone and hamstring tendon.

The study presents a modified technique using a partial-thickness QT graft with continuous-loop EndoButton fixation, which may enhance surgical outcomes and patient recovery in ACL reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior Cruciate Ligament Reconstruction With a Partial-Thickness Quadriceps Tendon Graft Secured With a Continuous-Loop Fixation Device. Hughes, JD., Vaswani, R., Gibbs, CM., et al.[2020]

The quadriceps tendon autograft is recommended as a superior alternative to the hamstring autograft for ACL reconstruction in pediatric patients, as it shows better preliminary outcomes and potentially lower rates of graft rupture.

Historically, 6% to 38% of pediatric patients using hamstring autografts experience graft rupture, highlighting the need for more effective graft options like the quadriceps tendon.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open Full-Thickness Quadriceps Tendon Autograft Harvest With Repair for Anterior Cruciate Ligament Reconstruction. Aitchison, AH., Schlichte, LM., Green, DW., et al.[2020]

In a study involving 28 patients with ACL injuries, those treated with quadriceps tendon (QT) autograft experienced similar pain levels and clinical outcomes compared to those treated with hamstring tendon (HT) autograft, as measured by various scoring systems over 12 months.

Both treatment groups showed significant improvement in knee function and pain post-surgery, indicating that QT autograft is a viable alternative to HT autograft for ACL reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior cruciate ligament injuries treated with quadriceps tendon autograft versus hamstring autograft: A randomized controlled trial. Vilchez-Cavazos, F., Dávila-Martínez, A., Garza-Castro, S., et al.[2022]

In a study of 48 patients undergoing ACL reconstruction, those who received a free quadriceps tendon autograft experienced significantly less pain and required fewer supplementary analgesics compared to those who received a hamstring tendon autograft.

Specifically, 50% of patients with the quadriceps graft did not need any additional pain relief, while only 13% of patients with the hamstring graft had the same outcome, indicating that the quadriceps graft may be a more effective option for reducing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain level after ACL reconstruction: A comparative study between free quadriceps tendon and hamstring tendons autografts. Buescu, CT., Onutu, AH., Lucaciu, DO., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Mid-Term Outcomes of the All-Soft Quadriceps Tendon Autograft Are Noninferior to Hamstring Autograft in Primary Anterior Cruciate Ligament Reconstruction: Comparison With Minimum 5-Year Follow-Up. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of Neuromuscular Firing Patterns of the Superficial Quadriceps in Soft Tissue Quadriceps Tendon Versus Bone-Patellar Tendon-Bone ACL Autografts. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Assessment of Return to Sport After ACL Reconstruction With Soft Tissue Autograft in Adolescent Athletes: Quadriceps Versus Hamstring Tendon. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Revision Anterior Cruciate Ligament Reconstruction with the All-Soft Tissue Quadriceps Tendon Autograft Has Acceptable Early and Intermediate-Term Outcomes. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Quadriceps tendon has a lower re-rupture rate than hamstring tendon autograft for anterior cruciate ligament reconstruction - A meta-analysis. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

There is no difference between quadriceps- and hamstring tendon autografts in primary anterior cruciate ligament reconstruction: a 2-year patient-reported outcome study. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Anterior Cruciate Ligament Reconstruction With a Partial-Thickness Quadriceps Tendon Graft Secured With a Continuous-Loop Fixation Device. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Open Full-Thickness Quadriceps Tendon Autograft Harvest With Repair for Anterior Cruciate Ligament Reconstruction. [2020]

9. Mexico pubmed.ncbi.nlm.nih.gov

Anterior cruciate ligament injuries treated with quadriceps tendon autograft versus hamstring autograft: A randomized controlled trial. [2022]

10. Turkey pubmed.ncbi.nlm.nih.gov

Pain level after ACL reconstruction: A comparative study between free quadriceps tendon and hamstring tendons autografts. [2022]