Study Stopped
Stopped for benefit of the MPFL reconstruction arm and due to safety concerns of the medial reefing arm.
A Prospective Randomized Study of Medial Patellofemoral Ligament (MPFL) Reconstruction
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 31, 2008
CompletedFirst Posted
Study publicly available on registry
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 14, 2011
July 1, 2009
2.5 years
December 31, 2008
June 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrent patellar instability
2 years
Secondary Outcomes (1)
Patellofemoral osteoarthrosis progression.
2 years
Study Arms (2)
1
ACTIVE COMPARATORMedial patellofemoral ligament reconstruction
2
ACTIVE COMPARATORMedial reefing
Interventions
Eligibility Criteria
You may qualify if:
- Chronic patellar instability (more than 2 dislocations)
- Minimum 6 months nonoperative treatment
You may not qualify if:
- Severe PF OA
- Acute patellar dislocation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Finnish Defense Forceslead
- Tampere University Hospitalcollaborator
Study Sites (1)
Tampere University Hospital
Tampere, 33521, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Petri J Sillanpaa, M.D., PhD
Tampere University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
December 31, 2008
First Posted
January 1, 2009
Study Start
December 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
June 14, 2011
Record last verified: 2009-07