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

Study Overview
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Brief Summary
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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

Detailed Description
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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)

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

Conditions
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Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear

Intervention / Treatment
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* Other: Rebound ACL brace and physioterapy
* Other: Physioterapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rebound ACL brace and physiotherapy<br>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<br>* Usage of rebound ACL brace and physioterapy supervised by physioterapist<br>|
| Active Comparator: Physiotherapy<br>A standardized rehab protocol comparable to the experimental group but with no brace | Other: Physioterapy<br>* Physioterapy supervised by physioterapist<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective knee function | EQ-5D-Y | 6, 12 and 24 months | 
| Subjective knee function | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL, children and adolescents, rebound ACL brace