Knee Function in Patients With Two or More Episodes of Patella Dislocations (MPFL)

October 25, 2022 updated by: Asbjorn Aroen

RCT Study:Knee Function in Patients With Two or More Episodes of Patella Dislocations

Patients aged 12 - 30 years, with recurrent patella dislocations, are consecutively included into a randomized prospective study. This study comparess the outcome of two forms of treatment for recurrent patella dislocation. One group is offered reconstruction of the medial patellofemoral ligament (MPFL), the second group is offered a standardized training program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction:

Patella dislocation is a serious knee injury whose peak incidence occurs in patients aged 10-17 years and is associated with a high rate of re-dislocation. Knee injuries frequently cause long-term disability and reduced physical activity among adolescents and young persons. Surgery in this patient group requires a low tolerance for complications, meaning that physical therapy might offer more successful outcomes in many knee injury cases. The proposed project studies a particular patient cohort subjected to recurrent dislocation of the patella.

Aim:

The principal objective of this clinical, randomized controlled trial is to evaluate and compare knee function and symptoms in patients with recurrent patella dislocation randomized into treatment with surgical reconstruction of the medial patellofemoral ligament (MPFL) with those of patients in a standardized physiotherapy program designed to stabilize the patella and improve patient function.

Materials and methods:

Patients aged 12-30 years who have experienced two or more patella dislocations are randomized into groups receiving either MPFL reconstruction or physical therapy only. Follow-ups at 3, 6, 12, and 36 months involve functional tests, validated knee scores, arthroscopic examination, and cartilage-specific MRI protocols for the knee.

Study Type

Interventional

Enrollment (Actual)

61

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

  • Norway
      • Lørenskog, Norway, 1478
        • Akershus University Hospital
      • Lørenskog, Norway, 1476
        • Akershus 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

12 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • More than one luxation
  • Norwegian citizens
  • Unilateral problems
  • Age range 12-30 years

Exclusion Criteria:

-Generalized degenerative changes

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MPFL group
Arthroscopy and MPFL reconstruction
Procedure: MPFL Group
MPFL reconstruction or standard treatment followed by physiotherapy
Other Names:
  • MPFL surgery
Procedure: Control
Arthroscopy followed by active rehabilitation
Other Names:
  • Arthroscopy
Active Comparator: Control
Arhroscopy and rehabilitation
Procedure: Control
Arthroscopy followed by active rehabilitation
Other Names:
  • Arthroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation
Time Frame: 2011-2022
Numbers of reoperation in the two treatment groups
2011-2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patella reluxation
Time Frame: 2011-2022
Number of reluxation of patella in the two treatment groups
2011-2022

Collaborators and Investigators

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

Sponsor

Asbjorn Aroen

Investigators

  • Study Chair: Asbjørn Årøen, MD,PhD, University Hospital, Akershus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 1, 2010

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

December 22, 2011

First Submitted That Met QC Criteria

October 10, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Actual)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/2148

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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