The goal of our study is to determine long-term follow up results of the uncemented primairy Delta Reversed Shoulder Prosthesis placed on basis of a non-traumatic etiology, such as rheumatoid arthritis, cuffarthopathy and osteoarthritis of the…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters/ outcome are:
1. Survivalanalysis of the Delta III prosthesis
2. X-rays of the shoulder (AP, Y and axial direction). These x-rays will be
retrospectively collected from the medical archives and newly taken
during the long-term follow-up controlvisit.
3. Clinical scores and questionnaires, retrospectively collected from the
medical archives and newly taken during the long-term follow-up
controlvisit.
- Constant * Murley Shoulderscore
- Simple Shoulder Test
- DASH score
- VAS score
4. Fysical examination in which ongoing functional complaints and the range of
motion are evaluated.
Secondary outcome
None
Background summary
The presentation of the Grammont shoulder prosthesis in 1981 was the start of a
very dynamic evolution of the reversed shoulder prosthesis. Eventually this has
lead to the development of the Delta III reversed shoulder prosthesis. Although
this prosthesis is now commonly used, only one study reports the mean long-term
follow-up outcome seven years after the operation. Seen the importance of this
data for choosing a prosthesis, our study has been set up.
Study objective
The goal of our study is to determine long-term follow up results of the
uncemented primairy Delta Reversed Shoulder Prosthesis placed on basis of a
non-traumatic etiology, such as rheumatoid arthritis, cuffarthopathy and
osteoarthritis of the shoulder.
Study design
Prospective follow * up study
Study burden and risks
There are no risks associated with the participation in the study. The extent
of the burden associated with the participation is comparable to a normal
postoperative controlvisit to the outpatient clinic. The burden consists of the
time spend on the examination (1 hour) and the exposure the the very low
radiation dose associated with the x-rays.
Van Riebeeckweg 212
Hilversum 1213 XZ
NL
Van Riebeeckweg 212
Hilversum 1213 XZ
NL
Listed location countries
Age
Inclusion criteria
Patients treated with primairy uncemented reversed shoulder prosthesis in the period between January 2000 and December 2006 by drs. M. de Vos in the Maartenskliniek (SMK) Nijmegen because of rheumatoid arthritis, cuffartheopathy, shoulder osteoarthritis. Age older than 18 years and willing to participate in the study.
Exclusion criteria
Not complying with inclusion criteria. Age < 18 years.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40579.048.12 |