Treatment of Acute ACL Injuries in Young Patients Using a Rebound ACL Brace

December 17, 2024 updated by: Frida Hansson, MD
This study evaluates the use of a brace in acute anterior cruciate ligament (ACL) injuries in children and adolescents. Half of the participants will receive a so called rebound ACL brace together with a standardized rehab program supervised by a physiotherapist, while the other half will receive only the standardized rehab program supervised by a physiotherapist

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

A well known treatment of posterior cruciate ligament injuries in the acute phase is a brace which pushes the tibia anteriorly, and the result of the treatment is often successful with healing of the ligament. Similarly, in anterior cruciate ligament injuries, it is suggested that a rebound ACL brace which pushes the tibia posteriorly can facilitate healing of the ACL. It does not have as successful treatment results as the PCL brace, but the type and location of the ACL injury has in previous studies not been well defined. We will, after having described the localisation and type of ACL injury treat the intervention group with the rebound ACL brace and a standardized rehab program and the control group with standardized rehab program alone.

The randomization is made blockwise of 4, to treatment A= Brace+physiotherapy or B=Physioterapy. The groups are stratified for gender and age (<=14 years and >14 years)

Study Type

Interventional

Enrollment (Actual)

44

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 Locations

  • Sweden
    • Sverige
      • Stockholm, Sverige, Sweden, 113 41
        • Capio Artro Clinic

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

No older than 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • No previous significant knee injury
  • Trauma followed by hemarthrosis and clinical suspicion of an acute ACL injury
  • Acute ACL rupture seen on MRI

Exclusion Criteria:

  • Previous ipsilateral knee surgery
  • Associated injuries which require early surgical intervention

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
Experimental: Rebound ACL brace and physiotherapy
The intervention will be the use of rebound ACL brace for 9 weeks, which initially is locked followed by a gradually increased range of motion. A standardized rehab protocol is applied.
Other: Rebound ACL brace and physioterapy
Usage of rebound ACL brace and physioterapy supervised by physioterapist
Active Comparator: Physiotherapy
A standardized rehab protocol comparable to the experimental group but with no brace
Other: Physioterapy
Physioterapy supervised by physioterapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective knee function
Time Frame: 6 months
laxity measurement (KT-1000)
6 months
Objective knee function
Time Frame: 12 months
laxity measurement (KT-1000)
12 months
Objective knee function
Time Frame: 24 months
laxity measurement (KT-1000)
24 months
objective knee function
Time Frame: 6 months
muscle strength (measured by Biodex)
6 months
objective knee function
Time Frame: 12 months
muscle strength (measured by Biodex)
12 months
objective knee function
Time Frame: 24 months
muscle strength (measured by Biodex)
24 months
objective knee function
Time Frame: 6 months
jump tests
6 months
objective knee function
Time Frame: 12 months
jump tests
12 months
objective knee function
Time Frame: 24 months
jump tests
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective knee function
Time Frame: 6, 12 and 24 months
EQ-5D-Y
6, 12 and 24 months
Subjective knee function
Time Frame: 6, 12 and 24 months
The Knee injury and Osteoarthritis Outcome Score for children, KOOS child. 5 subscales, where each subscale's points are calculated to a scale from 0-100; zero representing extreme knee problems and 100 representing no knee problems
6, 12 and 24 months
Activity level
Time Frame: 6, 12 and 24 months
Presented as Tegner activity scale. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
6, 12 and 24 months

Collaborators and Investigators

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

Sponsor

Frida Hansson, MD

Investigators

  • Principal Investigator: Frida Hansson, MD, PhD stud, Karolinska Institutet

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)

January 8, 2020

Primary Completion (Actual)

December 17, 2024

Study Completion (Actual)

December 17, 2024

Study Registration Dates

First Submitted

November 25, 2019

First Submitted That Met QC Criteria

December 2, 2019

First Posted (Actual)

December 4, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/1450-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Beginning 3 months and ending minimum 5 years following article publication

IPD Sharing Access Criteria

Proposals should be directed to frida.hansson@capio.se. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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.

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