Plain English Summary
Background and study aims
Osteoarthritis is a condition where the cartilage inside the hip joint becomes worn away, leading to the bones rubbing against each other and becoming damaged. There are several different types of surgery available for osteoarthritis. A total hip arthroplasty involves replacing the damaged hip joint with an artificial one. Hip resurfacing replaces just the diseased or damaged surfaces in the hip joint with metal implants - less bone is removed than if you have total hip arthroplasty. The aim of this study is to compare patient outcomes after hip resurfacing and cementless metal-on-metal total hip arthroplasty.
Who can participate?
Patients aged 18 to 60 with primary osteoarthritis of the hip
What does the study involve?
Participants are randomly allocated to undergo either cementless metal-on-metal total hip arthroplasty or hip resurfacing. Participants attend follow-up visits 2, 5 and 10 years later, where they undergo walking tests and pain, discomfort, osteoarthritis symptoms and quality of life are assessed.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Helsinki University Central Hospital (Finland)
When is the study starting and how long is it expected to run for?
November 2006 to December 2016
Who is funding the study?
1. Helsinki University Central Hospital (Finland)
2. Orion-Farmos Research Foundation (Finland)
Who is the main contact?
Dr Ville Remes
ville.remes@hus.fi
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ville Remes
ORCID ID
Contact details
Helsinki University Central Hospital
Surgical Hospital
P.O. Box 263
Helsinki
FIN-00029
Finland
-
ville.remes@hus.fi
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00570167
Protocol/serial number
TYH7306
Study information
Scientific title
Prospective randomised clinical trial comparing hip resurfacing and cementless metal-on-metal total hip arthroplasty
Acronym
Study hypothesis
To compare clinical, functional and radiological outcome after hip resurfacing and cementless metal-on-metal total hip arthroplasty.
Ethics approval
Ethical committee of Surgical Department, Turku University Central Hospital, 02/05/2006, ref: TEKOHeKuTu2006/11032006
Study design
Prospective randomised clinical trial
Primary study design
Interventional
Secondary study design
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
Hip osteoarthritis
Intervention
Cementless metal-on-metal total hip arthroplasty (Birmingham Hip Resurfacing arthroplasty [BHR]-Synergy) versus hip resurfacing (BHR). Follow-up visits will be at 2, 5 and 10 years.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Pain and discomfort on Visual Analogue Score (VAS) scale and in 7-point Likert-scale, measured at 2, 5 and 10 years
Secondary outcome measures
1. A difference of 15 points in the Western Ontario and McMasters Universities Osteoarthritic Index (WOMAC) questionnaire, converted to a scale of 0 to 100, measured at 2, 5 and 10 years
2. Difference in indicators of functional capacity (20-metre walking test and 3-metre "up and go" test), measured at 2, 5 and 10 years
3. Difference in the observed change in the quality of life, measured at 2, 5 and 10 years
4. Difference in the observed cost-effectiveness, measured at 2, 5 and 10 years
Overall trial start date
30/11/2006
Overall trial end date
31/12/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Primary osteoarthritis of the hip, planned to be treated by hip replacement surgery
2. Normal acetabulum, or no more than mild dysplasia of the acetabulum
3. Aged 18 to 60 years
4. The patient's mother tongue is Finnish
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
142
Participant exclusion criteria
1. Patient has a secondary osteoarthritis of hip
2. The patient has undergone endoprosthetic surgery of the other hip in the preceding six months, or such a procedure is planned for the patient in the next six months
3. The patient has undergone or is planned to undergo endoprosthetic surgery of the knee or ankle in the next year
4. The patient has undergone surgery of the other hip, knee or ankle with an unsatisfactory outcome
5. The patient has been diagnosed with or is suspected to have an untreated or recurring malignancy or systemic infection
6. A disease treated with cortisone or immunosuppressive medication
7. The patient's cooperation is impaired for any reason
8. Any systemic disease that impairs the patient's mobility
9. Female patients in fertile age who are planning to have children during the study
10. The patient has previously undergone an operation of the hip region that extended below the subcutaneous tissue
11. The patient has experienced a femoral neck fracture
12. The patient has been diagnosed with or is strongly suspected to have osteoporosis (T-score less than or equal to -2.5 SD)
13. The patient has a systemic or metabolic disease that has impaired or is going to impair bone quality
14. A significant cyst (diameter greater than 1 cm) or cysts in the area of the femoral neck
15. Bilateral simultaneous hip arthroplasty
16. Neck-shaft angle 120 degrees or less
17. Deformed femoral head making hip resurfacing impossible
18. Head-neck ratio less than 1.2
19. Avascular necrosis of the femoral head
Recruitment start date
30/11/2006
Recruitment end date
31/12/2016
Locations
Countries of recruitment
Finland
Trial participating centre
Helsinki University Central Hospital
Helsinki
FIN-00029
Finland
Sponsor information
Organisation
Helsinki University Central Hospital (Finland)
Sponsor details
Surgical Hospital
P.O. Box 263
Helsinki
FIN-00029
Finland
-
ville.remes@hus.fi
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Helsingin ja Uudenmaan Sairaanhoitopiiri
Alternative name(s)
Helsinki University Central Hospital, HUS
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Finland
Funder name
Orion-Farmos Research Foundation (Finland)
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