MRI Findings in Throwing Shoulders of Waterpolo Players | NCT00959543

Studies
MRI Findings in Throwing Shoulders of Waterpolo Players

NCT00959543

Sponsor

Cantonal Hospital of St. Gallen

Status

Completed

Last Update Posted

Jul 7, 2011Estimated

Enrollment

45Actual

Phase

Not Applicable

Conditions

Waterpolo Players
Non Throwing Shoulders

Interventions

Countries

Switzerland

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

Jun 2011

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

Jul 2009

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Aug 13, 2009

First Submission Date that Met QC Criteria

Aug 13, 2009

First Posted Date

Aug 14, 2009Estimated

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

Jul 6, 2011

Last Update Posted Date

Jul 7, 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

MRI examination of 60 shoulders of waterpolo players (30 throwing shoulders as well as the opposite side) and 15 healthy probands as control group (30 shoulders of non waterpolo players. The correlation of MRI alteration and clinical symptomatic findings in both groups will be investigated. The clinical examination is performed by 2 board certified orthopedic surgeons and based on the Constant Murley Score.

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

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
waterpolo players	Other	30 throwing shoulders of waterpolo players	Other: MRI
controle group	Other	15 healthy patients (non waterpolo players); 30 shoulders	Other: MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Other	MRI and clinical investigation	controle group waterpolo players

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between alterations of SSP-tendon in MRI and clinical symptoms		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Study shoulders of elite waterpolo players
Study shoulders of healthy non throwing persons
Age between 18-35 years
Male
Given informed consent

Exclusion Criteria:

Previous shoulder surgery
Goal keeper
Metallic implants
Pacemaker
Tattoos with metallic colors

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael A. Badulescu, MD	Cantonal Hospital of St. Gallen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Orthopedic Surgery		Sankt Gallen		9007	Switzerland