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Clinical Trials/NCT02263807
NCT02263807
Completed
Not Applicable

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

Asbjorn Aroen1 site in 1 country61 target enrollmentMay 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Joint Instability
Sponsor
Asbjorn Aroen
Enrollment
61
Locations
1
Primary Endpoint
Reoperation
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
January 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Asbjorn Aroen
Responsible Party
Sponsor Investigator
Principal Investigator

Asbjorn Aroen

Professor, Orthopaedic Surgeon

University Hospital, Akershus

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Generalized degenerative changes

Outcomes

Primary Outcomes

Reoperation

Time Frame: 2011-2022

Numbers of reoperation in the two treatment groups

Secondary Outcomes

  • Patella reluxation(2011-2022)

Study Sites (1)

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