Reversed TESS Shoulder Artroplasty | NCT01877434

Studies
Reversed TESS Shoulder Artroplasty

NCT01877434

Sponsor

Sundsvall Hospital

Status

Completed

Last Update Posted

Jun 13, 2013Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Humerus Fracture
Degenerative Shoulder Pain
Degenerative Supraspinatus Rupture

Interventions

Reversed shoulder arthroplasty

Countries

Sweden

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 2013

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

Oct 2007

Primary Completion Date

Jan 2012Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jun 11, 2013

First Submission Date that Met QC Criteria

Jun 11, 2013

First Posted Date

Jun 13, 2013Estimated

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

Jun 11, 2013

Last Update Posted Date

Jun 13, 2013Estimated

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

Reverse total shoulder arthroplasty (RSA) is a accepted treatment for different shoulder diseases with improved functional outcome. This study has evaluated patients operated with reversed shoulder arthroplasty after 1,5-3 years postoperatively with patient reported outcome, clinical and radiological examination, complication and reoperations. The radiologic phenomenom and clinical impact of scapular notching (SN) and arm length difference has been evaluated.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Reversed TESS		Patient undergone reversed shoulder arthroplasty	Procedure: Reversed shoulder arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Reversed shoulder arthroplasty	Procedure		Reversed TESS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient reported outcome measurement Quick-DASH		2007-2013

Secondary Outcomes

Measure	Description	Time Frame
Range of movement		2007-2013
Quality of life EQ5-D		2007-2013

Other Outcomes

Measure	Description	Time Frame
Arm lenght difference	Impact on arm lenght difference on patient reported outcome evaluated with Quick-DASH	2007-2013

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Operated with a reversed TESS total shoulder arthroplasty at Sundsvall hospital.

Exclusion Criteria:

Do not give informed consent
Do not attend follow-up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

88 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergone reversed shoulder arthroplasty at Sundsvall hospital, Sweden between 2007-2012

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institution of surgical and operative sciences, Umeå University		Sundsvall	Västernorrland Län		Sweden

Condition Browse Module

MeSH Terms

ID	Term
D006810	Humeral Fractures

Ancestor Terms

ID	Term
D001134	Arm Injuries
D014947	Wounds and Injuries
D050723	Fractures, Bone

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Browse Branches

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