NCT01877434

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2013

Completed
Last Updated

June 13, 2013

Status Verified

June 1, 2013

Enrollment Period

4.3 years

First QC Date

June 11, 2013

Last Update Submit

June 11, 2013

Conditions

Humerus FractureDegenerative Shoulder PainDegenerative Supraspinatus Rupture

Keywords

Reversed shoulder arthroplastyTreatmentTESS

Outcome Measures

Primary Outcomes (1)

  • Patient reported outcome measurement Quick-DASH

    2007-2013

Secondary Outcomes (2)

  • Range of movement

    2007-2013

  • Quality of life EQ5-D

    2007-2013

Other Outcomes (1)

  • Arm lenght difference

    2007-2013

Study Arms (1)

Reversed TESS

Patient undergone reversed shoulder arthroplasty

Procedure: Reversed shoulder arthroplasty

Interventions

Reversed shoulder arthroplastyPROCEDURE
Reversed TESS

Eligibility Criteria

Age60 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Do not give informed consent
  • Do not attend follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institution of surgical and operative sciences, Umeå University

Sundsvall, Västernorrland Län, Sweden

Location

MeSH Terms

Conditions

Humeral Fractures

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and InjuriesFractures, Bone

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultat medical doctor

Study Record Dates

First Submitted

June 11, 2013

First Posted

June 13, 2013

Study Start

October 1, 2007

Primary Completion

January 1, 2012

Study Completion

June 1, 2013

Last Updated

June 13, 2013

Record last verified: 2013-06

Locations

SE(1)