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

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04185532
• Other study ID #: 2018/1450-31
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2020
• Est. completion date: August 2025

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: Frida Hansson, MD
• Phone: +46705172742
• Email: frida.hansson[@]capio.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Rupture
• Anterior Cruciate Ligament Tear
• Rupture
• Wounds and Injuries

Intervention

Other:
• Rebound ACL brace and physioterapy
Usage of rebound ACL brace and physioterapy supervised by physioterapist
• Physioterapy
Physioterapy supervised by physioterapist

Locations

Country	Name	City	State
Sweden	Capio Artro Clinic	Stockholm	Sverige

Sponsors (1)

Lead Sponsor	Collaborator
Frida Hansson, MD

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Jacobi M, Reischl N, Ronn K, Magnusson RA, Gautier E, Jakob RP. Healing of the Acutely Injured Anterior Cruciate Ligament: Functional Treatment with the ACL-Jack, a Dynamic Posterior Drawer Brace. Adv Orthop. 2016;2016:1609067. doi: 10.1155/2016/1609067. Epub 2016 Dec 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective knee function	laxity measurement (KT-1000)	6 months
Primary	Objective knee function	laxity measurement (KT-1000)	12 months
Primary	Objective knee function	laxity measurement (KT-1000)	24 months
Primary	objective knee function	muscle strength (measured by Biodex)	6 months
Primary	objective knee function	muscle strength (measured by Biodex)	12 months
Primary	objective knee function	muscle strength (measured by Biodex)	24 months
Primary	objective knee function	jump tests	6 months
Primary	objective knee function	jump tests	12 months
Primary	objective knee function	jump tests	24 months
Secondary	Subjective knee function	EQ-5D-Y	6, 12 and 24 months
Secondary	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
Secondary	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