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A Prospective, Randomized Study of Operative and Nonoperative Treatment for Primary Traumatic Patellar Dislocation

Primary Purpose

Patellar Dislocation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
proximal patellar surgery
Nonoperative
Sponsored by
Finnish Defense Forces
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellar Dislocation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • An acute primary traumatic patellar dislocation

Exclusion Criteria:

  • Previous dislocation or subluxation of the patella
  • Pre-existing ipsilateral or contralateral knee pathology
  • Previous knee trauma or patellar fracture.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    1

    2

    Arm Description

    Operative

    Nonoperative

    Outcomes

    Primary Outcome Measures

    Number of redislocations

    Secondary Outcome Measures

    Full Information

    First Posted
    October 30, 2007
    Last Updated
    October 30, 2007
    Sponsor
    Finnish Defense Forces
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00551668
    Brief Title
    A Prospective, Randomized Study of Operative and Nonoperative Treatment for Primary Traumatic Patellar Dislocation
    Official Title
    A Prospective, Randomized Study of Operative and Nonoperative Treatment for Primary Traumatic Patellar Dislocation in Young Adults With a Median 7-Year Follow-Up
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1998 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2000 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Finnish Defense Forces

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of this prospective, randomized cohort study was to evaluate the clinical results between operative and nonoperative treatment of primary patellar dislocation.
    Detailed Description
    There is no consensus about management of acute traumatic primary patellar dislocations in young physically active adults. Acute lateral patellar dislocation is a relatively common injury among young adults. Proper treatment for this condition has been researched for decades. However, there is a lack of prospective randomized studies to evaluate the different treatment options for traumatic primary patellar dislocations. Therefore a prospective, randomized study was designed with the aim to compare the outcome of operative versus nonoperative treatment of primary traumatic patellar dislocations in young adults.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patellar Dislocation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Operative
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Nonoperative
    Intervention Type
    Procedure
    Intervention Name(s)
    proximal patellar surgery
    Intervention Description
    Initial proximal patellar surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    Nonoperative
    Intervention Description
    Nonoperative without surgery
    Primary Outcome Measure Information:
    Title
    Number of redislocations
    Time Frame
    7 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: An acute primary traumatic patellar dislocation Exclusion Criteria: Previous dislocation or subluxation of the patella Pre-existing ipsilateral or contralateral knee pathology Previous knee trauma or patellar fracture.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Harri Pihlajamäki, M.D., Ph.D.
    Organizational Affiliation
    Centre for Military Medicine, Lahti, Finland
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Prospective, Randomized Study of Operative and Nonoperative Treatment for Primary Traumatic Patellar Dislocation

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