Comparison of Hip Resurfacing and Cementless Metal-on-metal Total Hip Arthroplasty

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00570167
• Date of registration: 05/12/2007
• Primary sponsor: Helsinki University
• Public title: Comparison of Hip Resurfacing and Cementless Metal-on-metal Total Hip Arthroplasty
• Scientific title: Comparison of Hip Resurfacing and Cementless Metal-on-metal Total Hip Arthroplasty - Prospective Randomized Clinival Trial
• Date of first enrolment: November 2006
• Target sample size: 71
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00570167
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Finland

Contacts

• Name: Ville M Remes, MD, PhD
• Affiliation: Helsinki University Hospital

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hip Osteoarthritis

Intervention(s)

Procedure: Cementless total hip arthroplasty with m-o-m bearings

Procedure: Hip resurfacacing

Primary Outcome(s)

Pain and discomfort on Visual Analogue Score (VAS) scale and in 7-point Likert-scale. [Time Frame: At 2, 5 and 10 years]

Secondary Outcome(s)

A difference of 15 points in WOMAC questionnaire [Time Frame: At 2, 5 and 10 years]

Difference in 20-metre walking test and 3-metre "up and go" test [Time Frame: At 2, 5 and 10 years]

Difference in the observed change in the quality of life [Time Frame: At 2, 5 and 10 years]

Difference in the observed cost-effectiveness [Time Frame: At 2, 5 and 10 years]

Secondary ID(s)

ISRCTN60907614

TYH7306

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Kuopio University Hospital

University of Turku