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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00737087
Recruitment Status : Terminated (Study was stopped due to low follow-up compliance at study sites.)
First Posted : August 18, 2008
Last Update Posted : April 21, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : November 2007
Actual Primary Completion Date : October 2013
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Delta Xtend Reverse Total Shoulder
Orthopaedic implant for total shoulder replacement
Device: Delta Xtend Reverse Total Shoulder
Orthopaedic implant for total shoulder replacement

Primary Outcome Measures :
  1. Postoperative functionality through a difference in Constant Score post-treatment, as compared with pre-treatment results. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 12weeks, 1, 2, 5 and 10 years ]
  2. Determine implant survivorship and surgical revision information at 1, 2, 5 and 10 years via Kaplan-Meier survival analysis. [ Time Frame: 1, 2, 5 and 10 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00737087

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Universitair Ziekenhuis
Gent, Belgium, B-9000
Clinique Generale D'Annecy
Annecy, France, 74000
CHRU Reims Hôpital Maison Blanche
Reims, France, 51092
Polyclinique de l'Atlantique
St Herblain, France, 44819
Krankenhaus Munchen Bogenhausen
Munchen, Germany, 81925
Sponsors and Collaborators
DePuy International
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Responsible Party: DePuy International Identifier: NCT00737087    
Other Study ID Numbers: CT0515
First Posted: August 18, 2008    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: March 2016
Keywords provided by DePuy International:
total shoulder replacement
rotator cuff
rheumatoid arthritis
Delta Extend
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Rotator Cuff Tear Arthropathy
Wounds and Injuries
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Crystal Arthropathies