A Prospective Randomized Study of Medial Patellofemoral Ligament (MPFL) Reconstruction
Primary Purpose
Patella-Dislocation, Patellofemoral Osteoarthritis, Patellar Instability
Status
Terminated
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Patellofemoral stabilizing surgery
Sponsored by
About this trial
This is an interventional treatment trial for Patella-Dislocation focused on measuring Patella, Dislocation, Knee, Medial Patellofemoral Ligament
Eligibility Criteria
Inclusion Criteria:
- Chronic patellar instability (more than 2 dislocations)
- Minimum 6 months nonoperative treatment
Exclusion Criteria:
- Severe PF OA
- Acute patellar dislocation
Sites / Locations
- Tampere University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Medial patellofemoral ligament reconstruction
Medial reefing
Outcomes
Primary Outcome Measures
Recurrent patellar instability
Secondary Outcome Measures
Patellofemoral osteoarthrosis progression.
Full Information
NCT ID
NCT00816647
First Posted
December 31, 2008
Last Updated
June 13, 2011
Sponsor
Finnish Defense Forces
Collaborators
Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00816647
Brief Title
A Prospective Randomized Study of Medial Patellofemoral Ligament (MPFL) Reconstruction
Official Title
A Prospective Randomized Study of Medial Patellofemoral Ligament Reconstruction Compared With Medial Reefing
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Terminated
Why Stopped
Stopped for benefit of the MPFL reconstruction arm and due to safety concerns of the medial reefing arm.
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Finnish Defense Forces
Collaborators
Tampere University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The operative management of chronic patellar instability has been controversial. Medial patellofemoral ligament reconstruction has gained success recently and might be superior to other soft-tissue procedures. The objective of this prospective study was to compare the clinical outcome after medial patellofemoral ligament reconstruction compared with medial reefing for chronic patellar instability.
Detailed Description
Many of the previous studies on medial patellofemoral ligament (MPFL) reconstruction for patellar instability have been difficult to interpret, either because the study setting has included both first-time and recurrent dislocations, or because a lack of control group. Moreover, several studies have enrolled patients with a wide age range, and the majority of the studies have employed retrospective and nonrandomized study designs. Therefore the investigators designed a prospective, randomized study with the primary goal to compare the outcome after MPFL reconstruction with medial reefing for chronic patellar instability. The distance between tibial tubercle and trochlear groove is measured on MRI and corrected if it exceeds 17mm. Primary outcome measure is the occurrence of recurrent objective and subjective patellar instability. The second goal is to evaluate the development of articular cartilage lesions within the patellofemoral joint, and assess clinical scores.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patella-Dislocation, Patellofemoral Osteoarthritis, Patellar Instability
Keywords
Patella, Dislocation, Knee, Medial Patellofemoral Ligament
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Medial patellofemoral ligament reconstruction
Arm Title
2
Arm Type
Active Comparator
Arm Description
Medial reefing
Intervention Type
Procedure
Intervention Name(s)
Patellofemoral stabilizing surgery
Intervention Description
Comparison of surgical techniques
Primary Outcome Measure Information:
Title
Recurrent patellar instability
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Patellofemoral osteoarthrosis progression.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic patellar instability (more than 2 dislocations)
Minimum 6 months nonoperative treatment
Exclusion Criteria:
Severe PF OA
Acute patellar dislocation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petri J Sillanpaa, M.D., PhD
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
A Prospective Randomized Study of Medial Patellofemoral Ligament (MPFL) Reconstruction
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