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A Prospective Randomized Study of Medial Patellofemoral Ligament (MPFL) Reconstruction

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ClinicalTrials.gov Identifier: NCT00816647
Recruitment Status : Terminated (Stopped for benefit of the MPFL reconstruction arm and due to safety concerns of the medial reefing arm.)
First Posted : January 1, 2009
Last Update Posted : June 14, 2011
Sponsor:
Collaborator:
Tampere University Hospital
Information provided by:
Finnish Defense Forces

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.

Condition or disease Intervention/treatment Phase
Patella-Dislocation Patellofemoral Osteoarthritis Patellar Instability Procedure: Patellofemoral stabilizing surgery Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study of Medial Patellofemoral Ligament Reconstruction Compared With Medial Reefing
Study Start Date : December 2008
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Medial patellofemoral ligament reconstruction
Procedure: Patellofemoral stabilizing surgery
Comparison of surgical techniques
Active Comparator: 2
Medial reefing
Procedure: Patellofemoral stabilizing surgery
Comparison of surgical techniques



Primary Outcome Measures :
  1. Recurrent patellar instability [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Patellofemoral osteoarthrosis progression. [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic patellar instability (more than 2 dislocations)
  • Minimum 6 months nonoperative treatment

Exclusion Criteria:

  • Severe PF OA
  • Acute patellar dislocation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816647


Locations
Finland
Tampere University Hospital
Tampere, Finland, 33521
Sponsors and Collaborators
Finnish Defense Forces
Tampere University Hospital
Investigators
Principal Investigator: Petri J Sillanpaa, M.D., PhD Tampere University Hospital

Responsible Party: Petri Sillanpaa, M.D., Tampere University Hospital, Department of Musculosceletal Diseases
ClinicalTrials.gov Identifier: NCT00816647     History of Changes
Other Study ID Numbers: MPFL08
First Posted: January 1, 2009    Key Record Dates
Last Update Posted: June 14, 2011
Last Verified: July 2009

Keywords provided by Finnish Defense Forces:
Patella
Dislocation
Knee
Medial Patellofemoral Ligament

Additional relevant MeSH terms:
Osteoarthritis
Joint Dislocations
Patellar Dislocation
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bone Diseases
Wounds and Injuries
Knee Injuries
Leg Injuries