Prospective randomised clinical trial comparing hip resurfacing and cementless metal-on-metal total hip arthroplasty

ISRCTN	ISRCTN60907614
DOI	https://doi.org/10.1186/ISRCTN60907614
ClinicalTrials.gov number	NCT00570167
Secondary identifying numbers	TYH7306

Submission date: 11/05/2007
Registration date: 12/09/2007
Last edited: 15/04/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Ville Remes
Scientific

Helsinki University Central Hospital
Surgical Hospital
P.O. Box 263
Helsinki
FIN-00029
Finland

Email	ville.remes@hus.fi

Study information

Study design	Prospective randomised clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Prospective randomised clinical trial comparing hip resurfacing and cementless metal-on-metal total hip arthroplasty
Study objectives	To compare clinical, functional and radiological outcome after hip resurfacing and cementless metal-on-metal total hip arthroplasty.
Ethics approval(s)	Ethical committee of Surgical Department, Turku University Central Hospital, 02/05/2006, ref: TEKOHeKuTu2006/11032006
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	30/11/2006
Completion date	31/12/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	142
Key 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
Key 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
Date of first enrolment	30/11/2006
Date of final enrolment	31/12/2016

Locations

Countries of recruitment

Finland

Study participating centre

Helsinki University Central Hospital

Helsinki
FIN-00029
Finland

Sponsor information

Helsinki University Central Hospital (Finland)
Hospital/treatment centre

Surgical Hospital
P.O. Box 263
Helsinki
FIN-00029
Finland

Email	ville.remes@hus.fi
Website	http://www.hus.fi
"ROR"	https://ror.org/02e8hzf44

Funders

Funder type

Hospital/treatment centre

Helsingin ja Uudenmaan Sairaanhoitopiiri
Government organisation / Local government

Alternative name(s): Helsinki University Central Hospital, HUS
Location: Finland

Orion-Farmos Research Foundation (Finland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

15/04/2019: No publications found. Verifying results with principal investigator.
18/03/2016: Plain English summary added.