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

Frida Hansson, MD

Status: Terminated

Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Rupture

Treatments: Other: Physioterapy; Other: Rebound ACL brace and physioterapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04185532

2018/1450-31

Details and patient eligibility

About

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

Full 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)

Enrollment: 44 patients

Sex: All

Ages: Under 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Rebound ACL brace and physiotherapy

Experimental group

Description:

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.

Treatment:

Other: Rebound ACL brace and physioterapy

Physiotherapy

Active Comparator group

Description:

A standardized rehab protocol comparable to the experimental group but with no brace

Treatment:

Other: Physioterapy