Long-term Clinical Effectiveness of the Delta Xtend Reverse Total Shoulder

Not Applicable

Terminated

• Conditions: Cuff Tear Arthropathy; Osteoarthritis With Cuff Deficiency; Rheumatoid Arthritis; Post Traumatic Injury to Shoulder; Revision Surgery of a Failed Anatomic Shoulder Prosthesis
• Interventions: Device: Delta Xtend Reverse Total Shoulder

• Registration Number: NCT00737087
• Lead Sponsor: DePuy International

Brief Summary

This post-marketing study is designed to collect data relating to the use of the Delta Xtend™ Total Shoulder Replacement System in shoulder with rotator cuff deficiencies. This allows for continued monitoring of the performance and safety of the prosthesis in a broader range of clinical situations.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-08-15
• Study First Submitted QC: 2008-08-15
• Study First Posted: 2008-08-18
• Primary Completion: 2013-10
• Study Completion: 2015-08
• Status Verified: 2016-03
• Last Update Submitted: 2016-04-20
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Male or female subjects, aged less than 85 years inclusive.
• Subjects who have cuff tear arthropathy, osteoarthritis with cuff deficiency, rheumatoid arthritis, post traumatic injury, or a need for revision surgery of a failed anatomic prosthesis in the left or right shoulder, which requires (total) shoulder arthroplasty.
• Subjects with radiographic evidence of sufficient bone stock to seat and support the Delta XtendÔ Reverse Total Shoulder System.
• Subjects who in the opinion of the Clinical Investigator are considered suitable for treatment with the Delta Xtend Reverse Total Shoulder System.
• Patients with a life expectancy of greater than 12 months.
• Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
• Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

Exclusion Criteria

• Male and female subjects aged 86 years or older.
• Subjects with complete deltoid muscle palsy in the target joint as determined by clinical evaluation.
• Subjects with active local or systemic infection or with a history of general or local infections in the target joint over the past 12 months.
• Subjects with severe deformities, or tumours, that would impair fixation or proper positioning of the implant.
• Subjects with no significant muscle, nerve or vascular disease.
• Subjects with a pathology that, in the opinion of the Clinical Investigator, will adversely affect healing.
• Known allergic reactions to implant materials (e.g. bone cement, metal, polyethylene) implant corrosion or implant wear debris.
• Subjects with a known history of poor compliance to medical treatment.
• Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
• Women who are pregnant.
• Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
• Subjects who have participated in a clinical investigation with an investigational product in the last month.
• Subjects who are currently involved in any injury litigation claims.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Delta Xtend Reverse Total Shoulder	Delta Xtend Reverse Total Shoulder	Orthopaedic implant for total shoulder replacement

Primary Outcome Measures

Name	Time	Method
Postoperative functionality through a difference in Constant Score post-treatment, as compared with pre-treatment results.	2 years

Secondary Outcome Measures

Name	Time	Method
Postoperative functionality at 12weeks, 1, 2, 5 and 10 years through a difference in the Constant score, ASES score, U-Penn score and EQ-5D as compared with pre-treatment scores.	12weeks, 1, 2, 5 and 10 years
Determine implant survivorship and surgical revision information at 1, 2, 5 and 10 years via Kaplan-Meier survival analysis.	1, 2, 5 and 10 years

Trial Locations

Locations (5)

Polyclinique de l'Atlantique; 🇫🇷 St Herblain, France

Clinique Generale D'Annecy; 🇫🇷 Annecy, France

CHRU Reims Hôpital Maison Blanche; 🇫🇷 Reims, France

Krankenhaus Munchen Bogenhausen; 🇩🇪 Munchen, Germany

Universitair Ziekenhuis; 🇧🇪 Gent, Belgium