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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.)
Tampere University Hospital
Information provided by:
Finnish Defense Forces Identifier:
First received: December 31, 2008
Last updated: June 13, 2011
Last verified: July 2009
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
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:

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.

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00816647

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

Responsible Party: Petri Sillanpaa, M.D., Tampere University Hospital, Department of Musculosceletal Diseases 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:
Medial Patellofemoral Ligament

Additional relevant MeSH terms:
Patellar Dislocation
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Wounds and Injuries
Knee Injuries
Leg Injuries processed this record on October 21, 2016