Condition category
Musculoskeletal Diseases
Date applied
11/05/2007
Date assigned
12/09/2007
Last edited
18/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.hus.fi

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

Publication citations

Additional files

Editorial Notes

18/03/2016: Plain English summary added.