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

NCT ID: NCT04185532

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-08

Study Completion Date

2024-12-17

Brief Summary

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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

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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)

Conditions

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Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Tear

Keywords

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ACL children and adolescents rebound ACL brace

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Rebound ACL brace and physiotherapy

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.

Group Type EXPERIMENTAL

Rebound ACL brace and physioterapy

Intervention Type OTHER

Usage of rebound ACL brace and physioterapy supervised by physioterapist

Physiotherapy

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

Group Type ACTIVE_COMPARATOR

Physioterapy

Intervention Type OTHER

Physioterapy supervised by physioterapist

Interventions

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Rebound ACL brace and physioterapy

Usage of rebound ACL brace and physioterapy supervised by physioterapist

Intervention Type OTHER

Physioterapy

Physioterapy supervised by physioterapist

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Frida Hansson, MD

OTHER

Sponsor Role lead

Responsible Party

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Frida Hansson, MD

MD. Principal Investigator. PhD student

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Frida Hansson, MD, PhD stud

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Capio Artro Clinic

Stockholm, Sverige, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 28053787 (View on PubMed)

Other Identifiers

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2018/1450-31

Identifier Type: -

Identifier Source: org_study_id