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

June 13, 2011 updated by: Finnish Defense Forces

A Prospective Randomized Study of Medial Patellofemoral Ligament Reconstruction Compared With Medial Reefing

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33521
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe PF OA
  • Acute patellar dislocation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrent patellar instability
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Patellofemoral osteoarthrosis progression.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Finnish Defense Forces

Collaborators

Tampere University Hospital

Investigators

  • Principal Investigator: Petri J Sillanpaa, M.D., PhD, Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ANTICIPATED)

June 1, 2011

Study Completion (ANTICIPATED)

June 1, 2011

Study Registration Dates

First Submitted

December 31, 2008

First Submitted That Met QC Criteria

December 31, 2008

First Posted (ESTIMATE)

January 1, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 14, 2011

Last Update Submitted That Met QC Criteria

June 13, 2011

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPFL08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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