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
About this trial
This is an interventional treatment trial for Patellar Dislocation focused on measuring Patella, Knee, Brace
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
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
NCT ID
NCT01344915
First Posted
April 28, 2011
Last Updated
April 29, 2011
Sponsor
Tampere University Hospital
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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