Longterm Outcome of the Delta III Inverse Prosthesis

August 8, 2014 updated by: Matthias Flury, Schulthess Klinik

The Reverse Delta III Total Shoulder Prosthesis - Longerm Results in 98 Patients

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Constant Murley Score
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cASES
Time Frame: 10 years
10 years
pASES
Time Frame: 10 years
10 years
SF-36
Time Frame: 10 years
10 years
DASH-Questionannaire
Time Frame: 10 years
10 years
SPADI
Time Frame: 10 years
10 years
x-ray (Sperling Classification)
Time Frame: 10 years
10 years
x-ray (Sirveaux Classification)
Time Frame: 10 years
10 years
Description of the glenoid
Time Frame: 10 years

Description of the situation:

e.g.

  • any dissociation of the gleonid
  • any migration of the glenoid
10 years
Description of the stem
Time Frame: 10 years

Description of the situation:

e.g.

- change of the position
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schulthess Klinik

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

June 5, 2013

First Submitted That Met QC Criteria

June 5, 2013

First Posted (Estimate)

June 10, 2013

Study Record Updates

Last Update Posted (Estimate)

August 11, 2014

Last Update Submitted That Met QC Criteria

August 8, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Delta III

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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