Clinical trial NCT04185532: Treatment of Acute ACL Injuries in Young Patients Using a Rebound ACL Brace
Official title: Treatment of Acute ACL Injuries in Young Patients Using a Rebound ACL Brace
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Anterior Cruciate Ligament Rupture
Anterior Cruciate Ligament Tear
Keywords: ACL
children and adolescents
rebound ACL brace
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 44
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Objective knee function
timeFrame: 6 months
measure: Objective knee function
timeFrame: 12 months
measure: Objective knee function
timeFrame: 24 months
measure: objective knee function
timeFrame: 6 months
measure: objective knee function
timeFrame: 12 months
measure: objective knee function
timeFrame: 24 months
measure: objective knee function
timeFrame: 6 months
measure: objective knee function
timeFrame: 12 months
measure: objective knee function
timeFrame: 24 months
Secondary outcomes:
measure: Subjective knee function
timeFrame: 6, 12 and 24 months
measure: Subjective knee function
timeFrame: 6, 12 and 24 months
measure: Activity level
timeFrame: 6, 12 and 24 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Capio Artro Clinic
state: Sverige
Study officials:
affiliation: Karolinska Institutet
name: Frida Hansson, MD, PhD stud
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.