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
About this trial
This is an interventional treatment trial for Patellar Dislocation
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.
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
NCT ID
NCT00551668
First Posted
October 30, 2007
Last Updated
October 30, 2007
Sponsor
Finnish Defense Forces
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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