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

Sponsor
Frida Hansson, MD (Other)
Overall Status
Recruiting
CT.gov ID
NCT04185532
Collaborator
(none)
76
Enrollment
1
Location
2
Arms
57.8
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Rebound ACL brace and physioterapy
  • Other: Physioterapy
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
The knee laxity measurement with KT-1000 will be performed by an assessor without knowledge of type of intervention. Other outcome measures will not be masked.
Primary Purpose:
Treatment
Official Title:
Treatment of Acute ACL Injuries in Young Patients Using a Rebound ACL Brace
Actual Study Start Date :
Jan 8, 2020
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Objective knee function [6 months]

    laxity measurement (KT-1000)

  2. Objective knee function [12 months]

    laxity measurement (KT-1000)

  3. Objective knee function [24 months]

    laxity measurement (KT-1000)

  4. objective knee function [6 months]

    muscle strength (measured by Biodex)

  5. objective knee function [12 months]

    muscle strength (measured by Biodex)

  6. objective knee function [24 months]

    muscle strength (measured by Biodex)

  7. objective knee function [6 months]

    jump tests

  8. objective knee function [12 months]

    jump tests

  9. objective knee function [24 months]

    jump tests

Secondary Outcome Measures

  1. Subjective knee function [6, 12 and 24 months]

    EQ-5D-Y

  2. Subjective knee function [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

  3. Activity level [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Capio Artro Clinic Stockholm Sverige Sweden 113 41

Sponsors and Collaborators

  • Frida Hansson, MD

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Frida Hansson, MD, MD. Principal Investigator. PhD student, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT04185532
Other Study ID Numbers:
  • 2018/1450-31
First Posted:
Dec 4, 2019
Last Update Posted:
Sep 5, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Frida Hansson, MD, MD. Principal Investigator. PhD student, Karolinska Institutet
ACL
children and adolescents
rebound ACL brace
Additional relevant MeSH terms:
Wounds and Injuries
Rupture
Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of Sep 5, 2021