Reversed TESS Shoulder Artroplasty

Humerus Fracture Clinical Trial

— RTESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877434
• Other study ID #: 2012-201-31M
• Status: Completed
• Phase: N/A
• First received: June 11, 2013
• Last updated: June 11, 2013
• Start date: October 2007
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Sundsvall Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 88 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Degenerative Shoulder Pain
• Degenerative Supraspinatus Rupture
• Humeral Fractures
• Humerus Fracture
• Shoulder Pain

Intervention

Procedure:
• Reversed shoulder arthroplasty

Locations

Country	Name	City	State
Sweden	Institution of surgical and operative sciences, Umeå University	Sundsvall	Västernorrland län

Sponsors (1)

Lead Sponsor	Collaborator
Sundsvall Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Arm lenght difference	Impact on arm lenght difference on patient reported outcome evaluated with Quick-DASH	2007-2013	No
Primary	Patient reported outcome measurement Quick-DASH		2007-2013	No
Secondary	Range of movement		2007-2013	No
Secondary	Quality of life EQ5-D		2007-2013	No