Medium-term clinical and radiographic outcome of DePuy Delta Xtend reverse shoulder replacement at a minimum 5 year follow-up

Not Applicable

Completed

• Conditions: shoulder arthritis associated with rotator cuff tear; post traumatic shoulder arthritis with rotator cuff tear; massive irreparable rotator cuff tear with or without arthritis; Musculoskeletal - Osteoarthritis; Musculoskeletal - Other muscular and skeletal disorders; Surgery - Other surgery

• Registration Number: ACTRN12616000232437
• Lead Sponsor: DePuy International Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-19
• Study Completion: 2017-12-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Retrospective analysis of a consecutive series of prospectively enrolled patients following reverse TSA for a variety of indications using the DePuy Delta Xtend reverse RSA system.

Exclusion Criteria

Patients excuded if surgery not carried out by pre-designated surgeon, if a conventional TSA or other form of arthroplasty rather than a reverse TSA was performed, or if an alternative implant was used for the procedure.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical (objective examination and patient derived outcome from questionnaires) outcome analysis at a minimum of 5 years post-op following implantation of Delta Xtend reverse TSA.<br>Patient questionnaires include ASES Score, DASH, Oxford Score, and SF-12. All have been validated.<br>[minimum 5 years post-op. No maximum duration.];Standardised radiographic analysis of Delta Xtend reverse TSA at a minimum of 5 years [minimum 5 years post-op. No maximum duration.];Analysis to assess for the presence of recognised complications associated with the use of reverse TSA - these include dislocation, fracture, nerve injury, infection, loosening, notching, and ongoing pain. All patients have continued to be followed-up by primary investigator and all complications and re-operations to date have already been recorded.[minimum 5 years post-op. No maximum duration.]