Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04039971

Tendon-Bone Versus All-Soft-Tissue for ACL Reconstruction: A Patient-Blinded Randomized Clinical Trial

In primary pediatric Anterior cruciate ligament (ACL) reconstruction, the quadriceps tendon with either tendon and patellar bone or an all-tendon graft is commonly employed. However, no randomized control trial has sought to discern the superior graft option in regards to both short-term and long-term patient outcomes.The purpose of this study is to assess the differences between these two widely used surgical techniques in ACL reconstruction by examining short, intermediate, and long term outcomes of both approaches.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

12 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

It is well known that ACL injuries are among the most common sports and knee injuries. As a result, ACL reconstruction is at the forefront both in terms of research and development and advancements in technique. One focus of research is graft choice and the risks and benefits associated with each. There are multiple valid graft choices including bone-patellar tendon-bone, hamstring tendon, quadriceps tendon, quadriceps tendon-patellar bone, and allograft. Graft choice is often patient centered and based on both patient and surgeon considerations such as age, sex, activity level, surgeon preference and graft associated complications.

The present study seeks to compare the intraoperative, immediate perioperative, intermediate and long-term outcomes between tendon-bone and all-soft-tissue quadriceps tendon autograft in ACL reconstruction in adolescent patients. The investigators will analyze data on operative time, cost, complications, recovery of strength and range of motion, return to sports rates, patient reported outcomes, and failure rates. With this proposal the investigators hope to determine if there is a superior graft technique in this population. Both graft types are validated in the literature separately as options for ACL reconstruction in this age group. There has been no clinical research comparing the two graft types, and therefore no consensus is made among surgeons on whether to use tendon-bone or all-soft-tissue when it comes to the QT autograft. A secondary aim of this study is to obtain patient reported outcomes throughout the post-operative period to determine if the patient experience is different between the two graft types. This data may be used in guiding a surgeon's decision on which type to use with their patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females
  • Patients ages 12 to 19 (inclusive)
  • Patients undergoing primary ACL reconstruction

Exclusion criteria

  • Patients with an underlying neuromuscular diagnosis or neurological injury
  • Patients with lower extremity fractures, dislocations, or multi-ligamentous injuries, which required surgery, concurrent with or occurring two years or less prior to primary ACL injury.
  • Patients with an underlying systemic or musculoskeletal diagnosis

Treatment and study plan

ACL reconstruction

Procedure

Surgical techniques

Primary outcomes

  1. Short-Term Graft Superiority

    Time frame: 1 to 2 years

    Graft superiority will be evaluated by the time to return to sports and the length of return to sports.

  2. Long-Term Graft Superiority

    Time frame: 5 years

    Long-term graft superiority will be evaluated by graft failure rate or ACL re-rupture.

Secondary outcomes

  1. Patient Reported Outcomes

    Time frame: Pre-operative appointment, 3 months, 6 months, 12 months, 24 months, and 5 years post-operative appointments

    Patients will complete a survey at specific time points to gauge knee function throughout treatment.

  2. Time to Return to Sports Rates

    Time frame: As recorded in post-operative physical therapy visits (approx. 6 months to 1 year)

    Time to return to sports will be evaluated based on physical therapy milestones related to return to sports clearance.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Children's Hospital Colorado

Registry information

Official study title

Quadriceps Tendon Autograft, Tendon-Bone Versus All-Soft-Tissue for Anterior Cruciate Ligament Reconstruction: A Patient-Blinded Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2029
Study completion
2029
First posted
Jul 31, 2019
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.