Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
Conditions
Keywords
ACL, children and adolescents, rebound ACL brace
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
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)
Interventions
OTHERRebound ACL brace and physioterapy
Usage of rebound ACL brace and physioterapy supervised by physioterapist
OTHERPhysioterapy
Physioterapy supervised by physioterapist
Sponsors
Frida Hansson, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective knee function | 6 months | laxity measurement (KT-1000) |
| objective knee function | 6 months | muscle strength (measured by Biodex) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective knee function | 6, 12 and 24 months | EQ-5D-Y |
| 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. |
Countries
Sweden
Outcome results
None listed