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Anterior Cruciate Ligament InjuriesNCT04185532

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

A study testing Rebound ACL brace and physioterapy and Physioterapy in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by Frida Hansson, MD at 1 site in Sweden.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages Up to 17 yearsHealthy volunteers can take part
What is being tested?
Rebound ACL brace and physioterapy and Physioterapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteSweden
Study dates
8 Jan 2020to 17 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • No previous significant knee injury
  • Trauma followed by hemarthrosis and clinical suspicion of an acute ACL injury
  • Acute ACL rupture seen on MRI

Who cannot join

  • Previous ipsilateral knee surgery
  • Associated injuries which require early surgical intervention

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Capio Artro Clinic

    Stockholm, Sverige, 113 41

Other trials in Sweden

About this study

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

Read the 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)

Being tested
Rebound ACL brace and physioterapy, Physioterapy
Keywords
ACL, children and adolescents, rebound ACL brace
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rebound ACL brace and physioterapyOther

    Usage of rebound ACL brace and physioterapy supervised by physioterapist

  • PhysioterapyOther

    Physioterapy supervised by physioterapist

Study groups in NCT04185532
Study groupRoleWhat they receive
Rebound ACL brace and physiotherapyExperimentalThe 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.
Receives: Other: Rebound ACL brace and physioterapy
PhysiotherapyActive comparatorA standardized rehab protocol comparable to the experimental group but with no brace
Receives: Other: Physioterapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective knee function

    laxity measurement (KT-1000)

    Measured: 6 months

  2. Objective knee function

    laxity measurement (KT-1000)

    Measured: 12 months

  3. Objective knee function

    laxity measurement (KT-1000)

    Measured: 24 months

  4. objective knee function

    muscle strength (measured by Biodex)

    Measured: 6 months

  5. objective knee function

    muscle strength (measured by Biodex)

    Measured: 12 months

  6. objective knee function

    muscle strength (measured by Biodex)

    Measured: 24 months

  7. objective knee function

    jump tests

    Measured: 6 months

  8. objective knee function

    jump tests

    Measured: 12 months

  9. objective knee function

    jump tests

    Measured: 24 months

Secondary outcomes (3)

  1. Subjective knee function

    EQ-5D-Y

    Measured: 6, 12 and 24 months

  2. 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

    Measured: 6, 12 and 24 months

  3. 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.

    Measured: 6, 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2019
  2. Study start8 Jan 2020
  3. Primary completion17 Dec 2024
  4. Study completion17 Dec 2024

Why it stopped: The study was stopped due to problems with the brace in the majority of the patients in the treatment group; such as skin lesions, non-fitting brace and severe itching. Furthermore, half of the patients went on to ACLR.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04185532
Sponsor's protocol ID
2018/1450-31
Status last verified
Dec 2024
First submitted
25 Nov 2019
Last updated
20 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Publications

  • 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.

    PubMed 28053787

Questions about this trial

What is this clinical trial studying?

A study testing Rebound ACL brace and physioterapy and Physioterapy in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by Frida Hansson, MD at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The study was stopped due to problems with the brace in the majority of the patients in the treatment group; such as skin lesions, non-fitting brace and severe itching. Furthermore, half of the patients went on to ACLR.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective knee function (time frame: 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04185532, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.

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