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

NCT ID: NCT00551668

Last Updated: 2007-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Study Completion Date

2000-12-31

Brief Summary

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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

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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.

Conditions

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Patellar Dislocation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Operative

Group Type EXPERIMENTAL

proximal patellar surgery

Intervention Type PROCEDURE

Initial proximal patellar surgery

2

Nonoperative

Group Type EXPERIMENTAL

Nonoperative

Intervention Type PROCEDURE

Nonoperative without surgery

Interventions

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proximal patellar surgery

Initial proximal patellar surgery

Intervention Type PROCEDURE

Nonoperative

Nonoperative without surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Finnish Defense Forces

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Harri Pihlajamäki, M.D., Ph.D.

Role: STUDY_DIRECTOR

Centre for Military Medicine, Lahti, Finland

Other Identifiers

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R1199/8.1/D/II

Identifier Type: -

Identifier Source: org_study_id