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

This study has been terminated.
(Study was stopped due to low follow-up compliance at study sites.)
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00737087
First received: August 15, 2008
Last updated: August 4, 2014
Last verified: August 2014
  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
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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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 ]

Enrollment: 144
Study Start Date: October 2007
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Delta Xtend Reverse Total Shoulder
Orthopaedic implant for total shoulder replacement
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Belgium
Universitair Ziekenhuis
Gent, Belgium, B-9000
France
Clinique Generale D'Annecy
Annecy, France, 74000
CHRU Reims Hôpital Maison Blanche
Reims, France, 51092
Polyclinique de l'Atlantique
St Herblain, France, 44819
Germany
Krankenhaus Munchen Bogenhausen
Munchen, Germany, 81925
Sponsors and Collaborators
DePuy International
Investigators
Principal Investigator: Anders Ekelund St Görans Hospital, Stockholm, Sweden
  More Information

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00737087     History of Changes
Other Study ID Numbers: CT0515
Study First Received: August 15, 2008
Last Updated: August 4, 2014
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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Wounds and Injuries
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 01, 2014