Treatment of Acute ACL Injuries in Young Patients Using a Rebound ACL Brace
Primary Purpose
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Rebound ACL brace and physioterapy
Physioterapy
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring ACL, children and adolescents, rebound ACL brace
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
Sites / Locations
- Capio Artro ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rebound ACL brace and physiotherapy
Physiotherapy
Arm Description
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.
A standardized rehab protocol comparable to the experimental group but with no brace
Outcomes
Primary Outcome Measures
Objective knee function
laxity measurement (KT-1000)
Objective knee function
laxity measurement (KT-1000)
Objective knee function
laxity measurement (KT-1000)
objective knee function
muscle strength (measured by Biodex)
objective knee function
muscle strength (measured by Biodex)
objective knee function
muscle strength (measured by Biodex)
objective knee function
jump tests
objective knee function
jump tests
objective knee function
jump tests
Secondary Outcome Measures
Subjective knee function
EQ-5D-Y
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04185532
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Frida Hansson, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
Keywords
ACL, children and adolescents, rebound ACL brace
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rebound ACL brace and physiotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Physiotherapy
Arm Type
Active Comparator
Arm Description
A standardized rehab protocol comparable to the experimental group but with no brace
Intervention Type
Other
Intervention Name(s)
Rebound ACL brace and physioterapy
Intervention Description
Usage of rebound ACL brace and physioterapy supervised by physioterapist
Intervention Type
Other
Intervention Name(s)
Physioterapy
Intervention Description
Physioterapy supervised by physioterapist
Primary Outcome Measure Information:
Title
Objective knee function
Description
laxity measurement (KT-1000)
Time Frame
6 months
Title
Objective knee function
Description
laxity measurement (KT-1000)
Time Frame
12 months
Title
Objective knee function
Description
laxity measurement (KT-1000)
Time Frame
24 months
Title
objective knee function
Description
muscle strength (measured by Biodex)
Time Frame
6 months
Title
objective knee function
Description
muscle strength (measured by Biodex)
Time Frame
12 months
Title
objective knee function
Description
muscle strength (measured by Biodex)
Time Frame
24 months
Title
objective knee function
Description
jump tests
Time Frame
6 months
Title
objective knee function
Description
jump tests
Time Frame
12 months
Title
objective knee function
Description
jump tests
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Subjective knee function
Description
EQ-5D-Y
Time Frame
6, 12 and 24 months
Title
Subjective knee function
Description
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
Time Frame
6, 12 and 24 months
Title
Activity level
Description
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.
Time Frame
6, 12 and 24 months
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
based on self-representation of gender identity
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frida Hansson, MD
Phone
+46705172742
Email
frida.hansson@capio.se
First Name & Middle Initial & Last Name or Official Title & Degree
Per-Mats Janarv, Ass. Prof.
Phone
0707887511
Email
per-mats.janarv@capio.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frida Hansson, MD, PhD stud
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Capio Artro Clinic
City
Stockholm
State/Province
Sverige
ZIP/Postal Code
113 41
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frida Hansson, MD
Phone
0705172742
Email
frida.h.hansson@gmail.com
First Name & Middle Initial & Last Name & Degree
Per Mats Janarv, ass prof
Phone
0707887511
Email
per-mats.janarv@capio.se
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 3 months and ending minimum 5 years following article publication
IPD Sharing Access Criteria
Proposals should be directed to frida.hansson@capio.se. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website
IPD Sharing URL
https://staff.ki.se/ki-eln-the-electronic-notebook
Citations:
PubMed Identifier
28053787
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.
Results Reference
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Treatment of Acute ACL Injuries in Young Patients Using a Rebound ACL Brace
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