Immobilization in External Rotation of Acute Shoulder Dis... | NCT00196560

Studies
Immobilization in External Rotation of Acute Shoulder Dislocations

NCT00196560

Sponsor

Fowler Kennedy Sport Medicine Clinic

Status

Completed

Last Update Posted

Nov 30, 2015Estimated

Enrollment

50Actual

Phase

Phase 3

Conditions

Anterior Shoulder Dislocation

Interventions

Immobilization in External Rotation

Countries

Canada

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

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Jun 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

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

Nov 26, 2015

Last Update Posted Date

Nov 30, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sharon Griffin, Research Coordinator, Fowler Kennedy Sport Medicine ClinicPrincipal Investigator

Lead Sponsor

Fowler Kennedy Sport Medicine ClinicOTHER

Collaborators

Name	Class
The Physicians' Services Incorporated Foundation	OTHER
American Shoulder and Elbow Surgeons	OTHER

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

The purpose of this study is to determine whether immobilizing the affected shoulder of first time anterior shoulder dislocation patients in external rotation (vs immobilization in traditional internal rotation) reduces the rate of recurrent dislocations experienced in 24 months.

Detailed Description

Immobilizing the affected shoulder of first time anterior shoulder dislocation patients in external rotation (vs immobilization in traditional internal rotation)should reduce the rate of recurrent dislocations experienced in 24 months.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
exernal rotation	Experimental	external rotation at 90 degrees	Device: Immobilization in External Rotation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Immobilization in External Rotation	Device		exernal rotation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrent Instability at 24 months

Secondary Outcomes

Measure	Description	Time Frame
Time (weeks) to return to work and time(weeks) to return to sport
Complications (resulting from immobilization)
Compliance with immobilization protocol

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

skeletally mature patients less than 30 years of age
sustained an acute, first-time, traumatic anterior dislocation of the shoulder as defined by; i. Mechanism of abduction, external rotation ii. Sudden pain in the shoulder iii. Manipulative reduction required or iv. Radiograph documenting a dislocated joint
willing to participate in follow-up for at least two years

Exclusion Criteria:

incompetent or unwilling to consent
inability or unwillingness to comply with rehabilitative protocol or required follow-up assessments
previous instability of the affected shoulder
significant associated fracture (exception Hill Sachs or Bankart lesions)
concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program
a history of significant ligamentous laxity or demonstrated multi-directional instability of the contralateral shoulder
neurovascular compromise of the affected limb
a medical condition making the patient unable to wear a brace or sling

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert B Litchfield, MD, FRCS(C)	Fowler Kennedy Sport Medicine Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fowler Kennedy Sport Medicine Clinic		London	Ontario	N6A 3K7	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
5365161	Background	Kazar B, Relovszky E. Prognosis of primary dislocation of the shoulder. Acta Orthop Scand. 1969;40(2):216-24. doi: 10.3109/17453676908989501. No abstract available.
13367074	Background	ROWE CR. Prognosis in dislocations of the shoulder. J Bone Joint Surg Am. 1956 Oct;38-A(5):957-77. No abstract available.