Restricted vs. Free Knee Range Of Motion For Primary Trau... | NCT01344915

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

NCT01344915

Sponsor

Tampere University Hospital

Status

Unknown status

Last Update Posted

May 2, 2011Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Patellar Dislocation

Interventions

Locked knee brace
Locked knee brace

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Jan 2007Actual

Completion Date

Jun 2011Estimated

First Submitted Date

Apr 28, 2011

First Submission Date that Met QC Criteria

Apr 28, 2011

First Posted Date

Apr 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2011

Last Update Posted Date

May 2, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Knee brace	Active Comparator		Procedure: Locked knee brace
Locked knee brace	Active Comparator		Procedure: Locked knee brace

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Locked knee brace	Procedure		Knee brace
Locked knee brace

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patellar redislocation	The number of patients with patellar redislocation after initial treatment.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Petri J Sillanpää, MD PhD	Tampere University Hospital, Department of Orthopaedic Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampere University Hospital		Tampere		33521	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35438588	Derived	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.

ID	Term
D031222	Patellar Dislocation
D000092462	Patella Fracture

ID	Term
D004204	Joint Dislocations
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D014947	Wounds and Injuries