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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02263807
Recruitment Status : Active, not recruiting
First Posted : October 13, 2014
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Asbjorn Aroen, University Hospital, Akershus

Brief Summary:
Patients aged 12 - 30 years, with recurrent patella dislocations, are consecutively included into a randomized prospective study. This study addresses 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. 70 patients are evaluated in the study. 75 of those fulfilled the inclusion criteria and are included in the study currently.

Condition or disease Intervention/treatment Phase
Joint Instability Procedure: MPFL Group Procedure: Control Not Applicable

Detailed Description:
Exclusion criteria include bilateral dislocations, non compliance to rehabilitation, established patellofemoralarthrosis and tibial tuberosity trochlear groove distance (TT-TG) of more than 20 mm. The patients are preoperatively studied with computer tomography (CT) and magnetic resonance imaging (MRI) and must meet all inclusion criteria.In addition to imaging, all patients undergo clinical examinations, functional tests, arthroscopy, and Kujala score, Knee injury and Osteoarthritis Outcome Score (KOOS), Lysholm score, Tegner activity score, visual analogue scale (VAS) and Activity Scale.This follow-up is performed at 3 months,6 months,12 months and 36 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RCT Study:Knee Function in Patients With Two or More Episodes of Patella Dislocations
Actual Study Start Date : May 2010
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dislocations

Arm Intervention/treatment
Experimental: MPFL group
Arthroscopy and MPFL reconstruction
Procedure: MPFL Group
MPFL reconstruction or standard treatment followed by physiotherapy
Other Name: MPFL surgery

Procedure: Control
Arthroscopy followed by active rehabilitation
Other Name: Arthroscopy

Active Comparator: Control
Arhroscopy and rehabilitation
Procedure: Control
Arthroscopy followed by active rehabilitation
Other Name: Arthroscopy




Primary Outcome Measures :
  1. Reoperation [ Time Frame: 2011-2018 ]
    Numbers of reoperation in the two treatment groups


Secondary Outcome Measures :
  1. Patella reluxation [ Time Frame: 2011-2018 ]
    Number of reluxation of patella in the two treatment groups



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-Generalized degenerative changes


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263807


Locations
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Norway
Akershus University Hospital
Lørenskog, Norway, 1476
Akershus University Hospital
Lørenskog, Norway, 1478
Sponsors and Collaborators
Asbjorn Aroen
Investigators
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Study Chair: Asbjørn Årøen, MD,PhD University Hospital, Akershus

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Asbjorn Aroen, Professor, Orthopaedic Surgeon, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT02263807     History of Changes
Other Study ID Numbers: 2009/2148
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019

Keywords provided by Asbjorn Aroen, University Hospital, Akershus:
Patella luxation

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