|
ISRCTN
|
ISRCTN32884890
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Scottish Trial of Arthroplasty or Reduction for Subcapital fractures (STARS)
|
|
Scientific title
|
|
|
Acronym
|
STARS
|
|
Serial number at source
|
HTA 94/24/03
|
|
Study hypothesis
|
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.
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration.
|
|
Study design
|
Prospective randomised multicentre trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Injury, occupational diseases, poisoning: Musculoskeletal injury
|
|
Participants - inclusion criteria
|
Elderly patients with bipolar hemiarthroplasty, total hip arthroplasty or reduction and fixation.
|
|
Participants - exclusion criteria
|
Not provided at time of registration.
|
|
Anticipated start date
|
01/06/1996
|
|
Anticipated end date
|
31/08/2002
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
298
|
|
Interventions
|
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.
|
|
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.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration.
|
|
Sources of funding
|
NIHR Health Technology Assessment Programme - HTA (UK)
|
|
Trial website
|
http://www.abdn.ac.uk/hsru/hta/stars.shtml
|
|
Publications
|
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16202351
|
|
Contact name
|
Mr
John
Keating
|
|
Address
|
Department of Orthopaedics
University of Edinburgh
Royal Infirmary
Little France
Old Dalkeith Road
|
|
City/town
|
Edinburgh
|
|
Zip/Postcode
|
EH16 4SU
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)131 242 3436
|
|
Fax
|
+44 (0)131242 3413
|
|
Email
|
johnkeating@ed.ac.uk
|
|
Sponsor
|
Department of Health (UK)
|
|
Address
|
Quarry House
Quarry Hill
|
|
City/town
|
Leeds
|
|
Zip/Postcode
|
LS2 7UE
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1132 545 843
|
|
Email
|
Sheila.Greener@doh.gsi.gov.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/en/index.htm
|
|
Date applied
|
25/04/2003
|
|
Last edited
|
11/05/2009
|
|
Date ISRCTN assigned
|
25/04/2003
|
