OsteoarthrosisPhase 4NCT00116948
A Comparison of Two Total Hip Replacements: Hip Resurfacing System Versus Mallory-Head/Exeter
A Phase 4 study testing ReCap, Hip resurfacing system, Biomet in people with Osteoarthrosis, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to compare two total hip replacement systems: Hip Resurfacing System (ReCap) versus Mallory-Head/Exeter. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Osteoarthrosis
- What is being tested?
- ReCap, Hip resurfacing system, Biomet
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2005to Jan 2012
- 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with primary hip osteoarthrosis (OA).
- Informed patient consent in writing.
- Sufficient bone density to allow uncemented implantation of an acetabular component.
Who cannot join
- Presence of other metal implants.
- Working exposure of chrome, cobalt or molybdenum.
- Ingestion of multivitamin or medication containing chrome, cobalt or molybdenum.
- Kidney disease
- Hip joint dysplasia
- Patients with neuromuscular or vascular disease in the affected leg.
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- Patients who regularly take non-steroid anti-inflammatory drugs (NSAID) and cannot interrupt intake for the postoperative phase of the study.
- Patients with fracture sequelae.
- Female patients of childbearing capacity.
- Sequelae to previous hip joint disorder in childhood
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Orthopaedic Center, Aarhus University Hospital
Aarhus, Jylland, 8000
About this study
The purpose of this study is to compare two total hip replacement systems: Hip Resurfacing System (ReCap) versus Mallory-Head/Exeter.
Read the detailed description
In Denmark approximately 7000 primary hip replacements are implanted yearly, and the incidence is rising with the increasingly aging population. For older patients, the incidence of later revisions of hip implantation is low. Unfortunately, this is not true for younger patients. Approximately 20% of patients under 55 years of age at the time of surgery must have the hip implant renewed within 10 years.
This is primarily because of the wear generated by polyethylene debris. The polyethylene is associated with osteolysis in the proximity of the prosthesis leading to failure of the prosthesis.
This unsatisfactory result has led to the development of an alternative hip prosthesis especially to benefit younger and physically active people. The new prosthesis should produce less inflammatory debris and less osteolysis induced failure.
To avoid the polyethylene particles, a new type of prosthesis has been made articulating metal on metal. The Hip Resurfacing System consists of an alloy of chrome - cobalt - molybdenum. Another point of interest for this prosthesis is also the size of the articulating surfaces which are bigger than usual. This will theoretically participate in the generation of metal ions.
Study objectives:
- This randomised prospective study will investigate the emission of Co-, Cr- and Mb-ions from Hip Resurfacing System and Mallory-Head/Exeter implants, respectively. The emission is measured as the ion concentration in the urine and is correlated to the inflammatory response in fasting plasma before and after the operation.
- To assess the walking pattern postoperatively using a 3D gait analysis, Vicon Polygon.
- To assess the postoperative recovery using the Harris hip score and visual analogue scale.
- The migration of acetabular components will be evaluated by RSA, performing radiostereometric analyses at the Orthopaedic Center, Aarhus University Hospital. The follow-up RSA will be scheduled for week 1, as well as 3 months, 12 months, 24 months, and 5 years after surgery. Bone mineral density around the implanted femoral component will be examined by DEXA scan at week 1, as well as 1 year and 2 years after surgery.
- Conditions
- Osteoarthrosis
- Being tested
- ReCap, Hip resurfacing system, Biomet
- Keywords
- Osteoarthrosis, RSA, DEXA, Hip arthroplasty, Metal ion, Inflammatory response, Gait analysis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReCap, Hip resurfacing system, BiometDevice
ReCap total hip arthroplasty inserted according to manufactures manual.
What is being measured
The primary outcome is the main question the study is designed to answer.
Metal ion release evaluated in urine
Measured: three years
Gait pattern evaluated with 3D gait analysis, Vicon Polygon
Measured: two years
Bone mineral density (BMD) in surrounding bone of the prosthesis
Measured: three years
Prostheses migration evaluated by radiostereometric analysis (RSA)
Measured: three years
Proinflammatory- and bone degradation measures in blood samples
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2005 (estimated)
- Study startJan 2005
- Primary completionSep 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthrosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Biomet Merck Aps,Horsens, Denmark, Gigtforeningen, Sahva A/S, Borgervænget 5-7, København Ø, Denmark, Danske Fysioterapeuter, Regionshospitalet Silkeborg, Finnish Institute of Occupational Health, Regionshospitalet Hammel Neurocenter
- Responsible party
- Sponsor
- Investigators
- Kjeld Søballe, MD., Prof., Principal investigator, Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116948
- Sponsor's protocol ID
- 20030289
- Status last verified
- Dec 2014
- First submitted
- 30 Jun 2005
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Total Hip Replacements: Hip Resurfacing System Versus Mallory-Head/Exeter
- ClinicalTrials.gov ID
- NCT00116948
- Acronym / sponsor ID
- 20030289
- Conditions
- Osteoarthrosis
- Keywords
- Osteoarthrosis, RSA, DEXA, Hip arthroplasty, Metal ion, Inflammatory response, Gait analysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Biomet Merck Aps,Horsens, Denmark, Gigtforeningen, Sahva A/S, Borgervænget 5-7, København Ø, Denmark, Danske Fysioterapeuter, Regionshospitalet Silkeborg, Finnish Institute of Occupational Health, Regionshospitalet Hammel Neurocenter
- Study start
- Jan 2005
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 1 Jul 2005 (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.
The purpose of this study is to compare two total hip replacement systems: Hip Resurfacing System (ReCap) versus Mallory-Head/Exeter.
Detailed description
In Denmark approximately 7000 primary hip replacements are implanted yearly, and the incidence is rising with the increasingly aging population. For older patients, the incidence of later revisions of hip implantation is low. Unfortunately, this is not true for younger patients. Approximately 20% of patients under 55 years of age at the time of surgery must have the hip implant renewed within 10 years.
This is primarily because of the wear generated by polyethylene debris. The polyethylene is associated with osteolysis in the proximity of the prosthesis leading to failure of the prosthesis.
This unsatisfactory result has led to the development of an alternative hip prosthesis especially to benefit younger and physically active people. The new prosthesis should produce less inflammatory debris and less osteolysis induced failure.
To avoid the polyethylene particles, a new type of prosthesis has been made articulating metal on metal. The Hip Resurfacing System consists of an alloy of chrome - cobalt - molybdenum. Another point of interest for this prosthesis is also the size of the articulating surfaces which are bigger than usual. This will theoretically participate in the generation of metal ions.
Study objectives:
- This randomised prospective study will investigate the emission of Co-, Cr- and Mb-ions from Hip Resurfacing System and Mallory-Head/Exeter implants, respectively. The emission is measured as the ion concentration in the urine and is correlated to the inflammatory response in fasting plasma before and after the operation.
- To assess the walking pattern postoperatively using a 3D gait analysis, Vicon Polygon.
- To assess the postoperative recovery using the Harris hip score and visual analogue scale.
- The migration of acetabular components will be evaluated by RSA, performing radiostereometric analyses at the Orthopaedic Center, Aarhus University Hospital. The follow-up RSA will be scheduled for week 1, as well as 3 months, 12 months, 24 months, and 5 years after surgery. Bone mineral density around the implanted femoral component will be examined by DEXA scan at week 1, as well as 1 year and 2 years after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with primary hip osteoarthrosis (OA).
- Informed patient consent in writing.
- Sufficient bone density to allow uncemented implantation of an acetabular component.
Key exclusion criteria (10 listed)
- Presence of other metal implants.
- Working exposure of chrome, cobalt or molybdenum.
- Ingestion of multivitamin or medication containing chrome, cobalt or molybdenum.
- Kidney disease
- Hip joint dysplasia
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 |
|---|---|---|
| ReCap, Hip resurfacing system, BiometReCap total hip arthroplasty inserted according to manufactures manual. | Device | – |
Primary outcome
Metal ion release evaluated in urine
Time frame: three years
Gait pattern evaluated with 3D gait analysis, Vicon Polygon
Time frame: two years
Bone mineral density (BMD) in surrounding bone of the prosthesis
Time frame: three years
Prostheses migration evaluated by radiostereometric analysis (RSA)
Time frame: three years
Proinflammatory- and bone degradation measures in blood samples
Time frame: three 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 5 Dec 2014.
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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.
Kjeld Søballe, MD., Prof. principal investigator
Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ReCap, Hip resurfacing system, Biomet in people with Osteoarthrosis, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 10 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 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Metal ion release evaluated in urine (time frame: three years). The study lists 5 primary outcomes in all. 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 5 Dec 2014.