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

A Multi-centred, Non-comparative, Non-randomised, Open, Post Marketing Investigation to Look at the Long-term Clinical Efficacy of the Delta Xtend Reverse Total Shoulder Used in the Treatment of Shoulders With Rotator Cuff Deficiencies.

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, B-9000
    • Universitair Ziekenhuis
• France
  • Annecy, France, 74000
    • Clinique Générale d'Annecy
  • Reims, France, 51092
    • CHRU Reims Hôpital Maison Blanche
  • St Herblain, France, 44819
    • Polyclinique de l'Atlantique
• Germany
  • Munchen, Germany, 81925
    • Krankenhaus München Bogenhausen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Delta Xtend Reverse Total Shoulder; Orthopaedic implant for total shoulder replacement	Device: Delta Xtend Reverse Total Shoulder; Orthopaedic implant for total shoulder replacement

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: DePuy International

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 15, 2008
• First Submitted That Met QC Criteria: August 15, 2008
• First Posted (Estimate): August 18, 2008

Study Record Updates

• Last Update Posted (Estimate): April 21, 2016
• Last Update Submitted That Met QC Criteria: April 20, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: osteoarthritis; rheumatoid arthritis; rotator cuff; total shoulder replacement; Delta Extend
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Crystal Arthropathies; Chondrocalcinosis; Arthritis; Arthritis, Rheumatoid; Osteoarthritis; Wounds and Injuries; Rotator Cuff Tear Arthropathy
• Other Study ID Numbers: CT0515