Reversed TESS Shoulder Artroplasty (RTESS)

June 11, 2013 updated by: Lennart Bråbäck, Sundsvall Hospital

The TESS Reverse Shoulder Arthroplasty: Effect of Arm Lengthening and Early Scapular Notching at Three Years Follow-up

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Västernorrland län
      • Sundsvall, Västernorrland län, Sweden
        • Institution of surgical and operative sciences, Umeå University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 88 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Reversed TESS
Patient undergone reversed shoulder arthroplasty
Procedure: Reversed shoulder arthroplasty

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sundsvall Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

June 11, 2013

First Submitted That Met QC Criteria

June 11, 2013

First Posted (ESTIMATE)

June 13, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 13, 2013

Last Update Submitted That Met QC Criteria

June 11, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-201-31M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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