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Sponsors and Collaborators: |
Finnish Defense Forces Tampere University Hospital, Department of Musculosceletal Diseases |
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Information provided by: | Finnish Defense Forces |
ClinicalTrials.gov Identifier: | NCT00816647 |
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.
Condition | Intervention |
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Patella-Dislocation Patellofemoral Osteoarthritis Patellar Instability |
Procedure: Patellofemoral stabilizing surgery |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment |
Official Title: | A Prospective Randomized Study of Medial Patellofemoral Ligament Reconstruction Compared With Medial Reefing |
Estimated Enrollment: | 50 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2015 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Medial patellofemoral ligament reconstruction
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Procedure: Patellofemoral stabilizing surgery
Comparison of surgical techniques
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2: Active Comparator
Medial reefing
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Procedure: Patellofemoral stabilizing surgery
Comparison of surgical techniques
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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 we 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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Petri J Sillanpaa, M.D., PH.D. | petri.sillanpaa@uta.fi |
Finland | |
Tampere University Hospital | Recruiting |
Tampere, Finland, 33521 | |
Contact: Petri J Sillanpaa petri.sillanpaa@pshp.fi |
Principal Investigator: | Petri J Sillanpaa, M.D., PhD | Tampere University Hospital, Department of Musculosceletal Diseases |
Responsible Party: | Tampere University Hospital, Department of Musculosceletal Diseases ( Petri Sillanpaa, M.D. ) |
Study ID Numbers: | MPFL08 |
Study First Received: | December 31, 2008 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00816647 |
Health Authority: | Finland: Ministry of Social Affairs and Health |
Patella Dislocation Knee Medial Patellofemoral Ligament |
Patellar Dislocation Musculoskeletal Diseases Dislocations Osteoarthritis Joint Diseases Arthritis |
Wounds and Injuries Knee Injuries Disorders of Environmental Origin Leg Injuries Rheumatic Diseases |