Scottish Trial of Arthroplasty or Reduction for Subcapital fractures (STARS)

ISRCTN	ISRCTN32884890
DOI	https://doi.org/10.1186/ISRCTN32884890
Protocol serial number	HTA 94/24/03
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 10/07/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr John Keating
Scientific

Department of Orthopaedics
University of Edinburgh
Royal Infirmary
Little France
Old Dalkeith Road
Edinburgh
EH16 4SU
United Kingdom

Phone	+44 (0)131 242 3436
Email	johnkeating@ed.ac.uk

Study information

Primary study design	Interventional
Study design	Prospective randomised multicentre trial
Secondary study design	Randomised controlled trial
Scientific title	Scottish Trial of Arthroplasty or Reduction for Subcapital fractures (STARS)
Study acronym	STARS
Study objectives	In a prospective randomised multicentre trial we will evaluate the management of displaced subcapital fractures in fit elderly patients with bipolar hemiarthroplasty, total hip arthroplasty or reduction and fixation. The trial will be conducted under the auspices of the Scottish Orthopaedic Trial Network, which involves the four university orthopaedic centres and associated district general hospitals. Patients will be randomised to one of three treatment groups and will be followed up for a minimum of two years. Please note that, as of 11/05/2009, the anticipated end date has been updated from 31/08/2000 to 31/08/2002.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Injury, occupational diseases, poisoning: Musculoskeletal injury
Intervention	There are three treatment options: 1. One method of mending the break is with a type of screw, sometimes with a plate on its side; the two parts of the bone are joined together, and no bone is replaced. 2. A second method using a hip replacement. The ball at the end of the femur bone is replaced by an artificial 'ball' which is fixed into the top of the rest of the femur bone; the socket is not replaced. 3. The third method is also a type of hip replacement. Like the second method, the ball of the femur is replaced, but the socket in the hip bone is also replaced.
Intervention type	Other
Primary outcome measure(s)	Clinical outcome will include perioperative mortality and reoperation. Functional outcomes will be assessed using a hip rating questionnaire and the EuroQoL functional outcome questionnaire. A cost-effectiveness and cost utility analysis will be integrated into the study protocol.
Key secondary outcome measure(s)	Not provided at time of registration.
Completion date	31/08/2002

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Not Specified
Target sample size at registration	298
Total final enrolment	298
Key inclusion criteria	Elderly patients with bipolar hemiarthroplasty, total hip arthroplasty or reduction and fixation.
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/06/1996
Date of final enrolment	31/08/2002

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Department of Orthopaedics

Edinburgh
EH16 4SU
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2005		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

10/07/2019: Total final enrolment added.