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

October 30, 2007 updated by: Finnish Defense Forces

A Prospective, Randomized Study of Operative and Nonoperative Treatment for Primary Traumatic Patellar Dislocation in Young Adults With a Median 7-Year Follow-Up

The objective of this prospective, randomized cohort study was to evaluate the clinical results between operative and nonoperative treatment of primary patellar dislocation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Operative
Procedure: proximal patellar surgery
Initial proximal patellar surgery
Experimental: 2
Nonoperative
Procedure: Nonoperative
Nonoperative without surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of redislocations
Time Frame: 7 years
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Finnish Defense Forces

Investigators

  • Study Director: Harri Pihlajamäki, M.D., Ph.D., Centre for Military Medicine, Lahti, Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1998

Study Completion (Actual)

December 1, 2000

Study Registration Dates

First Submitted

October 30, 2007

First Submitted That Met QC Criteria

October 30, 2007

First Posted (Estimate)

October 31, 2007

Study Record Updates

Last Update Posted (Estimate)

October 31, 2007

Last Update Submitted That Met QC Criteria

October 30, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R1199/8.1/D/II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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