Knee Function in Patients With Two or More Episodes of Patella Dislocations (MPFL)
Primary Purpose
Joint Instability
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
MPFL Group
Control
Sponsored by
About this trial
This is an interventional treatment trial for Joint Instability focused on measuring Patella luxation
Eligibility Criteria
Inclusion Criteria:
- More than one luxation
- Norwegian citizens
- Unilateral problems
- Age range 12-30 years
Exclusion Criteria:
-Generalized degenerative changes
Sites / Locations
- Akershus University Hospital
- Akershus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MPFL group
Control
Arm Description
Arthroscopy and MPFL reconstruction
Arhroscopy and rehabilitation
Outcomes
Primary Outcome Measures
Reoperation
Numbers of reoperation in the two treatment groups
Secondary Outcome Measures
Patella reluxation
Number of reluxation of patella in the two treatment groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02263807
Brief Title
Knee Function in Patients With Two or More Episodes of Patella Dislocations
Acronym
MPFL
Official Title
RCT Study:Knee Function in Patients With Two or More Episodes of Patella Dislocations
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 2010 (Actual)
Primary Completion Date
January 2022 (Actual)
Study Completion Date
January 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Asbjorn Aroen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients aged 12 - 30 years, with recurrent patella dislocations, are consecutively included into a randomized prospective study. This study comparess the outcome of two forms of treatment for recurrent patella dislocation. One group is offered reconstruction of the medial patellofemoral ligament (MPFL), the second group is offered a standardized training program.
Detailed Description
Introduction:
Patella dislocation is a serious knee injury whose peak incidence occurs in patients aged 10-17 years and is associated with a high rate of re-dislocation. Knee injuries frequently cause long-term disability and reduced physical activity among adolescents and young persons. Surgery in this patient group requires a low tolerance for complications, meaning that physical therapy might offer more successful outcomes in many knee injury cases. The proposed project studies a particular patient cohort subjected to recurrent dislocation of the patella.
Aim:
The principal objective of this clinical, randomized controlled trial is to evaluate and compare knee function and symptoms in patients with recurrent patella dislocation randomized into treatment with surgical reconstruction of the medial patellofemoral ligament (MPFL) with those of patients in a standardized physiotherapy program designed to stabilize the patella and improve patient function.
Materials and methods:
Patients aged 12-30 years who have experienced two or more patella dislocations are randomized into groups receiving either MPFL reconstruction or physical therapy only. Follow-ups at 3, 6, 12, and 36 months involve functional tests, validated knee scores, arthroscopic examination, and cartilage-specific MRI protocols for the knee.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Instability
Keywords
Patella luxation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MPFL group
Arm Type
Experimental
Arm Description
Arthroscopy and MPFL reconstruction
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Arhroscopy and rehabilitation
Intervention Type
Procedure
Intervention Name(s)
MPFL Group
Other Intervention Name(s)
MPFL surgery
Intervention Description
MPFL reconstruction or standard treatment followed by physiotherapy
Intervention Type
Procedure
Intervention Name(s)
Control
Other Intervention Name(s)
Arthroscopy
Intervention Description
Arthroscopy followed by active rehabilitation
Primary Outcome Measure Information:
Title
Reoperation
Description
Numbers of reoperation in the two treatment groups
Time Frame
2011-2022
Secondary Outcome Measure Information:
Title
Patella reluxation
Description
Number of reluxation of patella in the two treatment groups
Time Frame
2011-2022
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
More than one luxation
Norwegian citizens
Unilateral problems
Age range 12-30 years
Exclusion Criteria:
-Generalized degenerative changes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asbjørn Årøen, MD,PhD
Organizational Affiliation
University Hospital, Akershus
Official's Role
Study Chair
Facility Information:
Facility Name
Akershus University Hospital
City
Lørenskog
ZIP/Postal Code
1476
Country
Norway
Facility Name
Akershus University Hospital
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
31286929
Citation
Straume-Naesheim TM, Randsborg PH, Mikaelsen JR, Sivertsen EA, Devitt B, Granan LP, Aroen A. Recurrent lateral patella dislocation affects knee function as much as ACL deficiency - however patients wait five times longer for treatment. BMC Musculoskelet Disord. 2019 Jul 8;20(1):318. doi: 10.1186/s12891-019-2689-7.
Results Reference
result
PubMed Identifier
35347375
Citation
Straume-Naesheim TM, Randsborg PH, Mikaelsen JR, Aroen A. Medial patellofemoral ligament reconstruction is superior to active rehabilitation in protecting against further patella dislocations. Knee Surg Sports Traumatol Arthrosc. 2022 Oct;30(10):3428-3437. doi: 10.1007/s00167-022-06934-3. Epub 2022 Mar 28.
Results Reference
result
Learn more about this trial
Knee Function in Patients With Two or More Episodes of Patella Dislocations
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