Condition category
Musculoskeletal Diseases
Date applied
12/12/2012
Date assigned
12/12/2012
Last edited
12/12/2012
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

Prof Damian Griffin

ORCID ID

Contact details

University of Warwick
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
damian.griffin@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11130

Study information

Scientific title

A randomised controlled trial of total resurfacing versus hemi re-surfacing in the treatment of primary osteoarthritis of the shoulder

Acronym

Study hypothesis

A randomised controlled trial of total resurfacing versus hemi resurfacing in the treatment of primary osteoarthritis

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=11130

Ethics approval

First MREC, 30 August 2011, ref: 11/WM/0245

Study design

Non-randomised interventional study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Musculoskeletal Disease

Intervention

Hemi Resurfacing Arthroplasty:
The humeral head is resurfaced and the glenoid remains intact with no surgical intervention

Total Resurfacing Arthroplasty:
Total Resurfacing Shoulder Arthroplasty. The glenoid and humeral head is resurfaced.

Followed up at 12 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Oxford Shoulder Score measured at baseline, 6 weeks, 3 months, 6 months and 12 months

Secondary outcome measures

No secondary outcome measures

Overall trial start date

31/01/2012

Overall trial end date

30/04/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patient has severe osteoarthritis of the shoulder
2. Patient is suitable for a total resurfacing of the shoulder
3. Patient is medically fit for surgery
4. Patients aged 18 years of age or older
5. Male or female participants

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 30

Participant exclusion criteria

1. Patients unlikely to be able to adhere to trial procedures
2. Patients not able to provide informed consent

Recruitment start date

31/01/2012

Recruitment end date

30/04/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Warwick
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

University of Warwick (UK)

Sponsor details

Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Sponsor type

University/education

Website

http://www2.warwick.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Research for Patient Benefit Programme (UK) ref: PB-PG-0110-21121

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