NCT01344915

Brief Summary

Knee immobilization in near extension has been proposed as a nonoperative treatment for primary traumatic patellar dislocation, although there exist no prospective studies regarding the method of immobilization. The objective of this prospective randomized study was to compare the clinical outcome after nonoperative treatment with restricted vs. free range of motion (ROM) for primary traumatic patellar dislocation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

May 2, 2011

Status Verified

January 1, 2005

Enrollment Period

1.1 years

First QC Date

April 28, 2011

Last Update Submit

April 29, 2011

Conditions

Patellar Dislocation

Keywords

PatellaKneeBrace

Outcome Measures

Primary Outcomes (1)

  • Patellar redislocation

    The number of patients with patellar redislocation after initial treatment.

Study Arms (2)

Knee brace

ACTIVE COMPARATOR
Procedure: Locked knee brace

Locked knee brace

ACTIVE COMPARATOR
Procedure: Locked knee brace

Interventions

Locked knee bracePROCEDURE
Knee brace

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A primary (first-time) patellar dislocation verified by clinical examination
  • Signs of patellar dislocation in MRI

You may not qualify if:

  • anyone with previous patellar instability
  • osteochondral fracture requiring surgery
  • associated knee injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

Related Publications (1)

  • Honkonen EE, Sillanpaa PJ, Reito A, Maenpaa H, Mattila VM. A Randomized Controlled Trial Comparing a Patella-Stabilizing, Motion-Restricting Knee Brace Versus a Neoprene Nonhinged Knee Brace After a First-Time Traumatic Patellar Dislocation. Am J Sports Med. 2022 Jun;50(7):1867-1875. doi: 10.1177/03635465221090644. Epub 2022 Apr 19.

    PMID: 35438588DERIVED

MeSH Terms

Conditions

Patellar DislocationPatella Fracture

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesKnee InjuriesLeg InjuriesKnee FracturesFractures, Bone

Study Officials

  • Petri J Sillanpää, MD PhD

    Tampere University Hospital, Department of Orthopaedic Surgery

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 28, 2011

First Posted

April 29, 2011

Study Start

December 1, 2005

Primary Completion

January 1, 2007

Study Completion

June 1, 2011

Last Updated

May 2, 2011

Record last verified: 2005-01

Locations

FI(1)