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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01873651
Other study ID # Delta III
Secondary ID
Status Withdrawn
Phase Phase 4
First received June 5, 2013
Last updated August 8, 2014
Start date October 2013
Est. completion date March 2014

Study information

Verified date August 2014
Source Schulthess Klinik
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Implantation of a Delta III Prosthesis
Implantation of a Delta III Prosthesis

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Schulthess Klinik

Outcome

Type Measure Description Time frame Safety issue
Primary Constant Murley Score 10 years No
Secondary cASES 10 years No
Secondary pASES 10 years No
Secondary SF-36 10 years No
Secondary DASH-Questionannaire 10 years No
Secondary SPADI 10 years No
Secondary x-ray (Sperling Classification) 10 years No
Secondary x-ray (Sirveaux Classification) 10 years No
Secondary Description of the glenoid Description of the situation:
e.g.
any dissociation of the gleonid
any migration of the glenoid
10 years No
Secondary Description of the stem Description of the situation:
e.g.
- change of the position
10 years No
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