NCT00551668

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 1998

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2000

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2007

Completed
Last Updated

October 31, 2007

Status Verified

October 1, 2007

First QC Date

October 30, 2007

Last Update Submit

October 30, 2007

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of redislocations

    7 years

Study Arms (2)

1

EXPERIMENTAL

Operative

Procedure: proximal patellar surgery

2

EXPERIMENTAL

Nonoperative

Procedure: Nonoperative

Interventions

Initial proximal patellar surgery

1
NonoperativePROCEDURE

Nonoperative without surgery

2

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • An acute primary traumatic patellar dislocation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patellar Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesKnee InjuriesLeg Injuries

Study Officials

  • Harri Pihlajamäki, M.D., Ph.D.

    Centre for Military Medicine, Lahti, Finland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 30, 2007

First Posted

October 31, 2007

Study Start

January 1, 1998

Study Completion

December 1, 2000

Last Updated

October 31, 2007

Record last verified: 2007-10