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

Not Applicable

Terminated

• Conditions: Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture
• Interventions: Other: Rebound ACL brace and physioterapy; Other: Physioterapy

• Registration Number: NCT04185532
• Lead Sponsor: Frida Hansson, MD

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)

Study Timeline

• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-04
• Study Start: 2020-01-08
• Status Verified: 2024-12
• Primary Completion: 2024-12-17
• Study Completion: 2024-12-17
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rebound ACL brace and physiotherapy	Rebound ACL brace and physioterapy	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.
Physiotherapy	Physioterapy	A standardized rehab protocol comparable to the experimental group but with no brace

Primary Outcome Measures

Name	Time	Method
objective knee function	24 months	jump tests
Objective knee function	24 months	laxity measurement (KT-1000)

Secondary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Capio Artro Clinic; 🇸🇪 Stockholm, Sverige, Sweden