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

February 15, 2024 updated by: University of Colorado, Denver

Quadriceps Tendon Autograft, Tendon-Bone Versus All-Soft-Tissue for Anterior Cruciate Ligament 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tendon-Bone Graft
Participants receive the Quadriceps Tendon Tendon-Bone Graft technique during ACL reconstruction.
Procedure: ACL Reconstruction
Surgical techniques
Active Comparator: All-Soft-Tissue Graft
Participants receive the Quadriceps Tendon All-Soft-Tissue Graft technique during ACL reconstruction.
Procedure: ACL Reconstruction
Surgical techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 to 2 years
Long-Term Graft Superiority
Time Frame: 5 years
Long-term graft superiority will be evaluated by graft failure rate or ACL re-rupture.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-operative appointment, 3 months, 6 months, 12 months, 24 months, and 5 years post-operative appointments
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.
As recorded in post-operative physical therapy visits (approx. 6 months to 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Children's Hospital Colorado

Investigators

  • Principal Investigator: Stephanie Mayer, MD, Children's Hospital Colorado

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2029

Study Registration Dates

First Submitted

July 26, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-1445

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared with individuals or organizations outside of the research team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anterior Cruciate Ligament Injuries

Clinical Trials on ACL Reconstruction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe