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

Primary Purpose

Hip Osteoarthritis

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Hip resurfacacing
Cementless total hip arthroplasty with m-o-m bearings
Sponsored by
University of Helsinki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring Osteoarthritis, Hip, Artroplasty, Resurfacing

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kuopio University Hospital
  • Turku University Hospital
  • Helsinki University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

2

1

Arm Description

Total cementless hip arthroplasty with metal-on-metal bearings

Hip resurfacing

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

A difference of 15 points in WOMAC questionnaire
Difference in 20-metre walking test and 3-metre "up and go" test
Difference in the observed change in the quality of life
Difference in the observed cost-effectiveness

Full Information

First Posted
December 5, 2007
Last Updated
August 3, 2009
Sponsor
University of Helsinki
Collaborators
Kuopio University Hospital, University of Turku
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1. Study Identification

Unique Protocol Identification Number
NCT00570167
Brief Title
Comparison of Hip Resurfacing and Cementless Metal-on-metal Total Hip Arthroplasty
Official Title
Comparison of Hip Resurfacing and Cementless Metal-on-metal Total Hip Arthroplasty - Prospective Randomized Clinival Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Helsinki
Collaborators
Kuopio University Hospital, University of Turku

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To compare clinical, functional and radiological outcome after hip resurfacing and cementless metal-on-metal total hip arthroplasty.
Detailed Description
While many problems associated with endoprosthetic surgery have been solved, there are still some open questions: In hip replacement one of the most controversial issues is the role and the indications for "resurfacing" (Schmalzried 2005, Hungerford 2005). Resurfacing In traditional hip replacement, the head of the femur is replaced with a metal head secured to a stem in the femoral canal. In hip resurfacing, the neck of the femur is not cut, and instead the head of the femur is capped with a hemispherical metal ball articulated with an acetabular cup. The concept of resurfacing was developed as early as the 1970s, but it was abandoned due to unsatisfactory results. The procedure started to spark new interest in the 1990s as the results improved due to improvements in the articulation surfaces and fixation techniques (Amstutz 1998), and it has become considerably more common in the 2000s. In Australia, for example, resurfacing procedures accounted for 9% of all hip replacement operations carried out as a consequence of primary osteoarthritis, and their use has increased 17-fold in the 2000s (Australian Orthopedic Association National Joint Replacement Registry). The partly assumed benefits of hip resurfacing include less bone resection in connection with the procedure, easiness of reoperation (a "conventional" replacement is carried out if reoperation is necessary), smaller risk of dislocation due to the larger head, and more physiological flexibility of the femur as the neck of the femur is not replaced with an inflexible metal stem. The short-term and mid-term results of modern resurfacing procedures presented in the reports of the developer clinics have been encouraging (Daniel 2004, Beaule 2004), but long-term results are lacking. Resurfacing procedures are technically more challenging and have given rise to complications that are not associated with conventional hip replacement, such as fractures of the femoral neck (Shimmin 2005). On the other hand, the socket and the diameter of the ball used in resurfacing procedures and conventional hip replacements are similar, and excellent results have been reached with modern conventional cementless stems (Eskelinen 2005). There are no published studies comparing modern resurfacing prostheses to solutions involving cementless stems with a large head and metal-on-metal articulation surfaces.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
Osteoarthritis, Hip, Artroplasty, Resurfacing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
71 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Arm Description
Total cementless hip arthroplasty with metal-on-metal bearings
Arm Title
1
Arm Type
Active Comparator
Arm Description
Hip resurfacing
Intervention Type
Procedure
Intervention Name(s)
Hip resurfacacing
Other Intervention Name(s)
BHR (Smith & Nephew, Memphis, TN, USA)
Intervention Description
Hip resurfacing with cementless acetabular cup and cemented femoral head
Intervention Type
Procedure
Intervention Name(s)
Cementless total hip arthroplasty with m-o-m bearings
Other Intervention Name(s)
BHR-cup and Synergy stem (Smith & Nephew. Memphis, TN, USA)
Intervention Description
Cementless monoblock acetabular cup and cementless femoral stem with modular large head and metal-on-metal bearings..
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
A difference of 15 points in WOMAC questionnaire
Time Frame
At 2, 5 and 10 years
Title
Difference in 20-metre walking test and 3-metre "up and go" test
Time Frame
At 2, 5 and 10 years
Title
Difference in the observed change in the quality of life
Time Frame
At 2, 5 and 10 years
Title
Difference in the observed cost-effectiveness
Time Frame
At 2, 5 and 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Neck-shaft angle 120 degrees or less Deformed femoral head making hip resurfacing impossible Head-neck ratio less than 1.2 Avascular necrosis of the femoral head
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ville M Remes, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
State/Province
Itä-Suomi
ZIP/Postal Code
70210
Country
Finland
Facility Name
Turku University Hospital
City
Turku
State/Province
Lounais-Suomi
ZIP/Postal Code
20520
Country
Finland
Facility Name
Helsinki University Hospital
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00029
Country
Finland

12. IPD Sharing Statement

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

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