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Restricted vs. Free Knee Range Of Motion For Primary Traumatic Patellar Dislocation

Primary Purpose

Patellar Dislocation

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Locked knee brace
Locked knee brace
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellar Dislocation focused on measuring Patella, Knee, Brace

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Tampere University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Knee brace

Locked knee brace

Arm Description

Outcomes

Primary Outcome Measures

Patellar redislocation
The number of patients with patellar redislocation after initial treatment.

Secondary Outcome Measures

Full Information

First Posted
April 28, 2011
Last Updated
April 29, 2011
Sponsor
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01344915
Brief Title
Restricted vs. Free Knee Range Of Motion For Primary Traumatic Patellar Dislocation
Official Title
RESTRICTED VS. FREE KNEE RANGE OF MOTION FOR PRIMARY TRAUMATIC PATELLAR DISLOCATION: A PROSPECTIVE RANDOMIZED STUDY
Study Type
Interventional

2. Study Status

Record Verification Date
January 2005
Overall Recruitment Status
Unknown status
Study Start Date
December 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tampere University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Dislocation
Keywords
Patella, Knee, Brace

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
Knee brace
Arm Type
Active Comparator
Arm Title
Locked knee brace
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Locked knee brace
Intervention Type
Procedure
Intervention Name(s)
Locked knee brace
Primary Outcome Measure Information:
Title
Patellar redislocation
Description
The number of patients with patellar redislocation after initial treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A primary (first-time) patellar dislocation verified by clinical examination Signs of patellar dislocation in MRI Exclusion Criteria: anyone with previous patellar instability osteochondral fracture requiring surgery associated knee injuries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petri J Sillanpää, MD PhD
Organizational Affiliation
Tampere University Hospital, Department of Orthopaedic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
35438588
Citation
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.
Results Reference
derived

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Restricted vs. Free Knee Range Of Motion For Primary Traumatic Patellar Dislocation

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