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

Patellar Dislocation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00551668
• Other study ID #: R1199/8.1/D/II
• Status: Completed
• Phase: N/A
• First received: October 30, 2007
• Last updated: October 30, 2007
• Start date: January 1998
• Est. completion date: December 2000

Study information

• Verified date: October 2007
• Source: Finnish Defense Forces
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dislocations
• Patellar Dislocation

Intervention

Procedure:
• proximal patellar surgery
Initial proximal patellar surgery
• Nonoperative
Nonoperative without surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Finnish Defense Forces

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of redislocations		7 years