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Long-Term Clinical Effectiveness of the Delta Xtend Reverse Total Shoulder
This study is currently recruiting participants.
Verified by DePuy International, August 2008
Sponsored by: DePuy International
Information provided by: DePuy International
ClinicalTrials.gov Identifier: NCT00737087
  Purpose

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.


Condition Intervention Phase
Cuff Tear Arthropathy
Osteoarthritis With Cuff Deficiency
Rheumatoid Arthritis
Post Traumatic Injury to Shoulder
Revision Surgery of a Failed Anatomic Shoulder Prosthesis
Device: Delta Xtend Reverse Total Shoulder
Phase IV

MedlinePlus related topics: Joint Disorders Osteoarthritis Rheumatoid Arthritis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: 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.

Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Postoperative functionality through a difference in Constant Score post-treatment, as compared with pre-treatment results. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative functionality at 12weeks, 1, 2, 5 and 10years through a difference in the Constant score, ASES score, U-Penn score and EQ-5D as compared with pre-treatment scores. [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Determine implant survivorship and surgical revision information at 1, 2, 5 and 10years via Kaplan-Meier survival analysis. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: October 2007
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Delta Xtend Reverse Total Shoulder
    Orthopaedic implant for total shoulder replacement
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737087

Contacts
Contact: Mick Borroff, BSc, MSc +44 113 387 7910 mborroff@its.jnj.com

Locations
Belgium
Universitair Ziekenhuis Recruiting
GENT, Belgium, B-9000
Principal Investigator: Dr L De Wilde            
France
CHRU Reims Hôpital Maison Blanche Recruiting
Reims, France, 51092
Principal Investigator: Dr C Nérot            
Polyclinique de l'Atlantique Recruiting
St Herblain, France, 44819
Principal Investigator: Dr D Capon            
Clinique Generale D'Annecy Recruiting
Annecy, France, 74000
Principal Investigator: Dr L Lafosse            
Germany
Krankenhaus Munchen Bogenhausen Recruiting
Munchen, Germany, 81925
Principal Investigator: Dr med L Seebauer            
Sweden
St Görans Hospital Recruiting
Stockholm, Sweden, 112 81
Principal Investigator: Dr Anders Ekelund            
Sponsors and Collaborators
DePuy International
Investigators
Principal Investigator: Anders Ekelund St Görans Hospital, Stockholm, Sweden
  More Information

Responsible Party: DePuy International Ltd ( Dr Victoria Cavendish )
Study ID Numbers: CT0515
Study First Received: August 15, 2008
Last Updated: August 15, 2008
ClinicalTrials.gov Identifier: NCT00737087  
Health Authority: Belgium: Institutional Review Board;   Sweden: Institutional Review Board;   France: Institutional Ethical Committee;   Germany: Ethics Commission;   Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by DePuy International:
total shoulder replacement
rotator cuff
osteoarthritis
rheumatoid arthritis
Delta Extend

Study placed in the following topic categories:
Lacerations
Autoimmune Diseases
Musculoskeletal Diseases
Osteoarthritis
Arthritis
Joint Diseases
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009