Condition category
Musculoskeletal Diseases
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
28/12/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr F Steenbrink

ORCID ID

Contact details

Leiden University Medical Center
Departement of Orthopaedics
Laboratory for Movement Analysis
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31(0)71 526 2581
f.steenbrink@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

p06.017

Study information

Scientific title

Acronym

Study hypothesis

Conform components are beneficial for motion coordination and reducing high rim-loads, while non-conform components are beneficial in reducing high humerus-to-scapula impulses (impact forces).

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, controlled, parallel group, double blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Shoulder disorders

Intervention

Total shoulder replacement

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Component fixation (Rontgen Stereophotographic Analysis [RSA])
2. Shoulder functioning (Range of Motion [RoM], Questionnaires for shoulder functioning)

Secondary outcome measures

1. Glenohumeral translation (Fluoroscopy)
2. Pain (Visual Analogue Scale [VAS])
3. Maximum arm force
4. Shoulder coordination (Principal action)
5. Proprosepsis (mirroring)

Overall trial start date

01/11/2006

Overall trial end date

01/11/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Individuals requiring primary arthroplasty as a result of osteoarthritis or rheumatoid arthritis.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

1. Rotator cuff tear, pre-operatively diagnosed by means of Magnetic Resonance Imaging (MRI)
2. Humeral component with a radius of 20 mm
3. Prior history of shoulder surgery

Recruitment start date

01/11/2006

Recruitment end date

01/11/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Center
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Center (LUMC) (The Netherlands)

Sponsor details

Department of Orthopaedics
Laboratory for Movement Analysis
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.lumc.nl/english/start_english.html#http://www.lumc.nl/english/start_english.html

Funders

Funder type

Industry

Funder name

Reumafonds (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes