Hip OsteoarthritisPhase 4NCT00570167
Comparison of Hip Resurfacing and Cementless Metal-on-metal Total Hip Arthroplasty
A Phase 4 study testing Hip resurfacacing and Cementless total hip arthroplasty with m-o-m bearings in people with Hip Osteoarthritis, run by University of Helsinki at 3 sites in Finland.
Trial summary
To compare clinical, functional and radiological outcome after hip resurfacing and cementless metal-on-metal total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Hip resurfacacing and Cementless total hip arthroplasty with m-o-m bearings
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 3 sitesFinland
- Study dates
- Nov 2006to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Helsinki University Hospital
Helsinki, Uusimaa, 00029
Kuopio University Hospital
Kuopio, Itä-Suomi, 70210
Turku University Hospital
Turku, Lounais-Suomi, 20520
About this study
Official title: Comparison of Hip Resurfacing and Cementless Metal-on-metal Total Hip Arthroplasty - Prospective Randomized Clinival Trial
To compare clinical, functional and radiological outcome after hip resurfacing and cementless metal-on-metal total hip arthroplasty.
Read the 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.
- Conditions
- Hip Osteoarthritis
- Being tested
- Hip resurfacacing, Cementless total hip arthroplasty with m-o-m bearings
- Keywords
- Osteoarthritis, Hip, Artroplasty, Resurfacing
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip resurfacacingProcedure or surgery
Also called BHR (Smith & Nephew, Memphis, TN, USA)
Hip resurfacing with cementless acetabular cup and cemented femoral head
Cementless total hip arthroplasty with m-o-m bearingsProcedure or surgery
Also called BHR-cup and Synergy stem (Smith & Nephew. Memphis, TN, USA)
Cementless monoblock acetabular cup and cementless femoral stem with modular large head and metal-on-metal bearings..
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Total cementless hip arthroplasty with metal-on-metal bearings Receives: Procedure: Cementless total hip arthroplasty with m-o-m bearings |
| 1 | Active comparator | Hip resurfacing Receives: Procedure: Hip resurfacacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and discomfort on Visual Analogue Score (VAS) scale and in 7-point Likert-scale.
Measured: At 2, 5 and 10 years
Secondary outcomes (4)
A difference of 15 points in WOMAC questionnaire
Measured: At 2, 5 and 10 years
Difference in 20-metre walking test and 3-metre "up and go" test
Measured: At 2, 5 and 10 years
Difference in the observed change in the quality of life
Measured: At 2, 5 and 10 years
Difference in the observed cost-effectiveness
Measured: At 2, 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2007 (estimated)
- Study startNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Kuopio University Hospital, University of Turku
- Investigators
- Ville M Remes, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570167
- Sponsor's protocol ID
- TYH7306
- Other IDs
- ISRCTN60907614
- Status last verified
- Aug 2009
- First submitted
- 5 Dec 2007
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hip Resurfacing and Cementless Metal-on-metal Total Hip Arthroplasty - Prospective Randomized Clinival Trial
- ClinicalTrials.gov ID
- NCT00570167
- Acronym / sponsor ID
- TYH7306
- Conditions
- Hip Osteoarthritis
- Keywords
- Osteoarthritis, Hip, Artroplasty, Resurfacing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Kuopio University Hospital, University of Turku
- Study start
- Nov 2006
- First posted
- 10 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Procedure: Cementless total hip arthroplasty with m-o-m bearingsTotal cementless hip arthroplasty with metal-on-metal bearings |
| 1 | Active comparator | Procedure: Hip resurfacacingHip resurfacing |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip resurfacacingAlso: BHR (Smith & Nephew, Memphis, TN, USA)Hip resurfacing with cementless acetabular cup and cemented femoral head | Procedure or surgery | 1 |
| Cementless total hip arthroplasty with m-o-m bearingsAlso: BHR-cup and Synergy stem (Smith & Nephew. Memphis, TN, USA)Cementless monoblock acetabular cup and cementless femoral stem with modular large head and metal-on-metal bearings.. | Procedure or surgery | 2 |
Primary outcome
Pain and discomfort on Visual Analogue Score (VAS) scale and in 7-point Likert-scale.
Time frame: At 2, 5 and 10 years
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ville M Remes, MD, PhD principal investigator
Helsinki University Central Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hip resurfacacing and Cementless total hip arthroplasty with m-o-m bearings in people with Hip Osteoarthritis, run by University of Helsinki at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain and discomfort on Visual Analogue Score (VAS) scale and in 7-point Likert-scale. (time frame: At 2, 5 and 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2009.