Condition category
Musculoskeletal Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
10/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr AL Wallace

ORCID ID

Contact details

Orthopaedic & Trauma Surgery
Imperial College of Medicine
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
+44 (0)20 8846 1479
andrew.wallace@ic.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0016089960

Study information

Scientific title

Acronym

Study hypothesis

1. Is the functional outcome of arthroscopic stabilisation as good as, or superior to, conventional open stabilisation?
2. What is the pathological basis for the relatively poorer results in patients with atraumatic instability?

Ethics approval

Not provided at time of registration

Study design

Randomised prospective clinical controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Arthroscopic stabilisation

Intervention

Patients are randomised to:
1. Arthroscopic shoulder stabilisation
2. Open shoulder stabilisation

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Comparison of both types of surgery. Dissemination of results.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/1999

Overall trial end date

31/03/2006

Reason abandoned

Lack of participants and funding

Eligibility

Participant inclusion criteria

100 orthopaedic patients from Charing Cross Hospital.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/1999

Recruitment end date

31/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Orthopaedic & Trauma Surgery
London
W6 8RF
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Hammersmith Hospital NHS Trust (UK)

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