Longterm Outcome of the Delta III Inverse Prosthesis
Primary Purpose
Rotator Cuff Tear Arthropathy
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Implantation of a Delta III Prosthesis
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tear Arthropathy
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Delta III
Arm Description
Implantation of a Delta III Prosthesis
Outcomes
Primary Outcome Measures
Constant Murley Score
Secondary Outcome Measures
cASES
pASES
SF-36
DASH-Questionannaire
SPADI
x-ray (Sperling Classification)
x-ray (Sirveaux Classification)
Description of the glenoid
Description of the situation:
e.g.
any dissociation of the gleonid
any migration of the glenoid
Description of the stem
Description of the situation:
e.g.
- change of the position
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01873651
Brief Title
Longterm Outcome of the Delta III Inverse Prosthesis
Official Title
The Reverse Delta III Total Shoulder Prosthesis - Longerm Results in 98 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Withdrawn
Why Stopped
The study has been withdrawn due to too few patients
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schulthess Klinik
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to describe the results after > 10 years due to a prosthesis implant.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear Arthropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Delta III
Arm Type
Experimental
Arm Description
Implantation of a Delta III Prosthesis
Intervention Type
Device
Intervention Name(s)
Implantation of a Delta III Prosthesis
Intervention Description
Implantation of a Delta III Prosthesis
Primary Outcome Measure Information:
Title
Constant Murley Score
Time Frame
10 years
Secondary Outcome Measure Information:
Title
cASES
Time Frame
10 years
Title
pASES
Time Frame
10 years
Title
SF-36
Time Frame
10 years
Title
DASH-Questionannaire
Time Frame
10 years
Title
SPADI
Time Frame
10 years
Title
x-ray (Sperling Classification)
Time Frame
10 years
Title
x-ray (Sirveaux Classification)
Time Frame
10 years
Title
Description of the glenoid
Description
Description of the situation:
e.g.
any dissociation of the gleonid
any migration of the glenoid
Time Frame
10 years
Title
Description of the stem
Description
Description of the situation:
e.g.
- change of the position
Time Frame
10 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Flury, Dr.
Organizational Affiliation
Schulthess Klinik, Upper Extremities Department
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Longterm Outcome of the Delta III Inverse Prosthesis
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