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

Not Applicable

Completed

• Conditions: Hip osteoarthritis; Musculoskeletal Diseases; Arthropathies

• Registration Number: ISRCTN60907614
• Lead Sponsor: Helsinki University Central Hospital (Finland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-09-12
• Study Completion: 2016-12-31
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 142

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> 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<br> 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<br> 3. Difference in the observed change in the quality of life, measured at 2, 5 and 10 years<br> 4. Difference in the observed cost-effectiveness, measured at 2, 5 and 10 years<br>