Conform and non conform glenoid components in total shoulder replacements

ISRCTN	ISRCTN42881741
DOI	https://doi.org/10.1186/ISRCTN42881741
Protocol serial number	p06.017
Sponsor	Leiden University Medical Center (LUMC) (The Netherlands)
Funder	Reumafonds (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr F Steenbrink
Scientific

Leiden University Medical Center
Departement of Orthopaedics
Laboratory for Movement Analysis
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31(0)71 526 2581
Email	f.steenbrink@lumc.nl

Primary study design	Interventional
Study design	Randomised, controlled, parallel group, double blinded trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Shoulder disorders
Intervention	Total shoulder replacement
Intervention type	Other
Primary outcome measure(s)	1. Component fixation (Rontgen Stereophotographic Analysis [RSA]) 2. Shoulder functioning (Range of Motion [RoM], Questionnaires for shoulder functioning)
Key secondary outcome measure(s)	1. Glenohumeral translation (Fluoroscopy) 2. Pain (Visual Analogue Scale [VAS]) 3. Maximum arm force 4. Shoulder coordination (Principal action) 5. Proprosepsis (mirroring)
Completion date	01/11/2010

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	20
Key inclusion criteria	Individuals requiring primary arthroplasty as a result of osteoarthritis or rheumatoid arthritis.
Key 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
Date of first enrolment	01/11/2006
Date of final enrolment	01/11/2010

Leiden University Medical Center

Leiden
2300 RC
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan