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

NCT00570167 | Completed Phase 4

• 2 other identifiers: TYH7306ISRCTN60907614
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 3

Brief Summary

To compare clinical, functional and radiological outcome after hip resurfacing and cementless metal-on-metal total hip arthroplasty.

Conditions

Hip Osteoarthritis

Keywords

Osteoarthritis; Hip; Artroplasty; Resurfacing

Outcome Measures

Primary Outcomes (1)

• Pain and discomfort on Visual Analogue Score (VAS) scale and in 7-point Likert-scale.

  At 2, 5 and 10 years

Secondary Outcomes (4)

• A difference of 15 points in WOMAC questionnaire

  At 2, 5 and 10 years

• Difference in 20-metre walking test and 3-metre "up and go" test

  At 2, 5 and 10 years

• Difference in the observed change in the quality of life

  At 2, 5 and 10 years

• Difference in the observed cost-effectiveness

  At 2, 5 and 10 years

Study Arms (2)

2

ACTIVE COMPARATOR

Total cementless hip arthroplasty with metal-on-metal bearings

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

1

ACTIVE COMPARATOR

Hip resurfacing

Procedure: Hip resurfacacing

Interventions

Hip resurfacacing PROCEDURE

Hip resurfacing with cementless acetabular cup and cemented femoral head

Also known as: BHR (Smith & Nephew, Memphis, TN, USA)

1

Cementless total hip arthroplasty with m-o-m bearings PROCEDURE

Cementless monoblock acetabular cup and cementless femoral stem with modular large head and metal-on-metal bearings..

Also known as: BHR-cup and Synergy stem (Smith & Nephew. Memphis, TN, USA)

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primary osteoarthritis of the hip, planned to be treated by hip replacement surgery
• Normal acetabulum, or no more than mild dysplasia of the acetabulum
• Aged 18 to 60 years
• The patient's mother tongue is Finnish

You may not qualify if:

• Patient has a secondary osteoarthritis of hip
• 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
• The patient has undergone or is planned to undergo endoprosthetic surgery of the knee or ankle in the next year
• The patient has undergone surgery of the other hip, knee or ankle with an unsatisfactory outcome
• The patient has been diagnosed with or is suspected to have an untreated or recurring malignancy or systemic infection
• A disease treated with cortisone or immunosuppressive medication
• The patient's cooperation is impaired for any reason
• Any systemic disease that impairs the patient's mobility
• Female patients in fertile age who are planning to have children during the study
• The patient has previously undergone an operation of the hip region that extended below the subcutaneous tissue
• The patient has experienced a femoral neck fracture
• The patient has been diagnosed with or is strongly suspected to have osteoporosis (T-score less than or equal to -2.5 SD)
• The patient has a systemic or metabolic disease that has impaired or is going to impair bone quality
• A significant cyst (diameter greater than 1 cm) or cysts in the area of the femoral neck
• Bilateral simultaneous hip arthroplasty

Sponsors & Collaborators

• University of Helsinki: lead
• Kuopio University Hospital: collaborator
• University of Turku: collaborator

Study Sites (3)

Kuopio University Hospital

Kuopio, Itä-Suomi, 70210, Finland

Location

Turku University Hospital

Turku, Lounais-Suomi, 20520, Finland

Location

Helsinki University Hospital

Helsinki, Uusimaa, 00029, Finland

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ville M Remes, MD, PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 10, 2007
• Study Start: November 1, 2006
• Last Updated: August 6, 2009

Record last verified: 2009-08

Locations

FI (3)