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

This study has been terminated.
(Stopped for benefit of the MPFL reconstruction arm and due to safety concerns of the medial reefing arm.)
Sponsor:
Collaborator:
Tampere University Hospital, Department of Musculosceletal Diseases
Information provided by:
Finnish Defense Forces
ClinicalTrials.gov Identifier:
NCT00816647
First received: December 31, 2008
Last updated: June 13, 2011
Last verified: July 2009
History of Changes
  Purpose

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
Patella-Dislocation
Patellofemoral Osteoarthritis
Patellar Instability
 Procedure: Patellofemoral stabilizing surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study of Medial Patellofemoral Ligament Reconstruction Compared With Medial Reefing

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Finnish Defense Forces:

Primary Outcome Measures:
  • Recurrent patellar instability [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patellofemoral osteoarthrosis progression. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816647

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

No publications provided

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
Study First Received: December 31, 2008
Last Updated: June 13, 2011
Health Authority: Finland: Ministry of Social Affairs and Health

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

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

ClinicalTrials.gov processed this record on May 22, 2013