Research with human participants

Overview of medical research in the Netherlands

Resurfacing schouder prothese, radiologische en klinische follow up

No registrations found.

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Ethical review
Positive opinion
Status
Recruiting
Health condition type
-
Study type
Observational non invasive

ID

NL-OMON24598

Source

Nationaal Trial Register

Brief title

CHEESE: Copeland Hemiprothesis Extended Effectiveness Study and Evaluation

Health condition

primary osteoarthritis
shoulder
Hemiprothesis
Copeland
radiological
clinical

Sponsors and support

Primary sponsor :
N/A
Source(s) of monetary or material Support :
N/A

Intervention

Outcome measures

Primary outcome

Shoulder function:

Constant score

DASH score

Simple Shoulder Test (SST)

Secondary outcome

Pain, quality of life and patient satisfaction:

Visual Analogue Scale (VAS)

EuroQol-5D questionnaire

Background summary

Cementless surface replacement arthroplasty (CSRA) of the shoulder has been used for several decades. Published data on functional outcome is limited. The aim of this retrospective study is to reports on the clinical and radiological outcome of CSRA in patients with primary osteoarthritis of the shoulder.

Study objective

Cementless surface replacement arthroplasty (CSRA) of the shoulder has been used for several decades. Published data on functional outcome is limited. The aim of this retrospective study is to reports on the clinical and radiological outcome of CSRA in patients with primary osteoarthritis of the shoulder.

Study design

5 Years follow up

Intervention

The Copeland Hemiprothesis

Public
Department of Orthopedic Surgery, Orbis Medisch Centrum<br>
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@zuyderland.nl
Scientific
Department of Orthopedic Surgery, Orbis Medisch Centrum<br>
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@zuyderland.nl

Inclusion criteria

Primary glenohumeral osteoarthritis, intact rotator cuff, follow-up of at least 5 years and provision of consent

Exclusion criteria

Preoperative diagnosis other than primary osteoarthritis (e.g. rheumatoid arthritis, instability arthropathy, post-traumatic arthropathy and avascular necrosis) and no provision of consent. Patients who where unable to complete the PROMs were excluded from clinical evaluation

Design

Study type :
Observational non invasive
Intervention model
:
Parallel
Allocation :
Non-randomized controlled trial
Masking :
Open (masking not used)
Control :
Active

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
40
Type :
Anticipated

IPD sharing statement

Plan to share IPD :
Undecided

Positive opinion
Date :
Application type :
First submission

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
NTR-new NL3910
NTR-old NTR4080
Other - : 12N140
ISRCTN ISRCTN wordt niet meer aangevraagd.

Summary results

N/A