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Longterm Outcome of the Delta III Inverse Prosthesis

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.
ClinicalTrials.gov Identifier: NCT01873651
Recruitment Status : Withdrawn (The study has been withdrawn due to too few patients)
First Posted : June 10, 2013
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
Matthias Flury, Schulthess Klinik

Brief Summary:
The aim of the study is to describe the results after > 10 years due to a prosthesis implant.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Arthropathy Device: Implantation of a Delta III Prosthesis Phase 4

Detailed Description:
The aim of the study is to measure the gain of the benefit in function an painreduction which the patient yields with this type of prosthesis in a longterm (> 10 years )outcome. Additionally the long-term results will be compared with the mid-term results and the literature. Furthermore the complications since the mid-term measurement time point will be determined.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Reverse Delta III Total Shoulder Prosthesis - Longerm Results in 98 Patients
Study Start Date : October 2013
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arm Intervention/treatment
Experimental: Delta III
Implantation of a Delta III Prosthesis
Device: Implantation of a Delta III Prosthesis
Implantation of a Delta III Prosthesis




Primary Outcome Measures :
  1. Constant Murley Score [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. cASES [ Time Frame: 10 years ]
  2. pASES [ Time Frame: 10 years ]
  3. SF-36 [ Time Frame: 10 years ]
  4. DASH-Questionannaire [ Time Frame: 10 years ]
  5. SPADI [ Time Frame: 10 years ]
  6. x-ray (Sperling Classification) [ Time Frame: 10 years ]
  7. x-ray (Sirveaux Classification) [ Time Frame: 10 years ]
  8. Description of the glenoid [ Time Frame: 10 years ]

    Description of the situation:

    e.g.

    • any dissociation of the gleonid
    • any migration of the glenoid

  9. Description of the stem [ Time Frame: 10 years ]

    Description of the situation:

    e.g.

    - change of the position




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • implantation of a Delta III - prothesis
  • timeframe (Oct 1998 - Dec 2002)
  • delta-pectoral approach
  • written informed consent

Exclusion Criteria:

  • Implantation because of a revision
  • Complaints, which make it difficult to follow instructions or even prevent

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 ClinicalTrials.gov identifier (NCT number): NCT01873651


Sponsors and Collaborators
Schulthess Klinik
Investigators
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Principal Investigator: Matthias Flury, Dr. Schulthess Klinik, Upper Extremities Department

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Responsible Party: Matthias Flury, Principal Investigator (Department of Upper Extremity), Schulthess Klinik
ClinicalTrials.gov Identifier: NCT01873651     History of Changes
Other Study ID Numbers: Delta III
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: August 11, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
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Rotator Cuff Injuries
Joint Diseases
Rotator Cuff Tear Arthropathy
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Musculoskeletal Diseases
Chondrocalcinosis
Arthritis
Crystal Arthropathies