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Longterm Outcome of the Delta III Inverse Prosthesis

Sponsor
Schulthess Klinik (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01873651
Collaborator
(none)
0
Enrollment
1
Arm
5
Duration (Months)

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
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 :
Oct 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2013
Anticipated Study Completion Date :
Mar 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Constant Murley Score [10 years]

Secondary Outcome Measures

  1. cASES [10 years]

  2. pASES [10 years]

  3. SF-36 [10 years]

  4. DASH-Questionannaire [10 years]

  5. SPADI [10 years]

  6. x-ray (Sperling Classification) [10 years]

  7. x-ray (Sirveaux Classification) [10 years]

  8. Description of the glenoid [10 years]

    Description of the situation: e.g. any dissociation of the gleonid any migration of the glenoid

  9. Description of the stem [10 years]

    Description of the situation: e.g. - change of the position

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Schulthess Klinik

Investigators

  • Principal Investigator: Matthias Flury, Dr., Schulthess Klinik, Upper Extremities Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Matthias Flury, Principal Investigator (Department of Upper Extremity), Schulthess Klinik
ClinicalTrials.gov Identifier:
NCT01873651
Other Study ID Numbers:
  • Delta III
First Posted:
Jun 10, 2013
Last Update Posted:
Aug 11, 2014
Last Verified:
Aug 1, 2014
Additional relevant MeSH terms:
Rotator Cuff Tear Arthropathy
Rotator Cuff Injuries

Study Results

No Results Posted as of Aug 11, 2014