OsteoarthritisPhase 4RSANCT01618084
RSA Study Using Two Types of Uncemented Acetabular Components and the Uncemented HA Coated Symax Stem
A Phase 4 study testing Tritanium acetabular component in people with Osteoarthritis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The Trident Tritanium acetabular component of a total hip prosthesis is a new developed uncemented acetabular component. In this randomized controlled trial (RCT) the tritanium cup will be compared with the Trident HA acetabular component in two equal sized groups. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Tritanium acetabular component
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2011to Dec 2014
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a BMI < 35
- Patients requiring uncemented primary THA
- Primary diagnosis of osteoarthritis
Who cannot join
- patients with acetabular or femoral osteotomy
- Patients who had a THA on the contralateral side within last 6 months
- Female patients who are pregnant or planning pregnancy during the course of the study
- Patients with active or suspected infection
- patients with malignancy
- patients with a systemic disease that would effect the subject's welfare or overall outcome of the study
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- Patients with a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device
- Patients with systemic or metabolic disorders leading to progressive bone deterioration
- Patients with other illnesses which are likely to affect their outcome
- Patients with known sensitivity to device materials
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht UMC
Maastricht
Liesbeth Jutten, l.jutten@mumc.nl
About this study
Official title: A Prospective Randomised Rontgen Stereophotogrammatic Analysis (RSA) Study Using the Uncemented Trident Tritanium Acetabular Component and the Uncemented HA Coated Symax Hip Stem in a Single Centre: Assessment of Implant Migration, Bone Remodeling and Clinical Function
The Trident Tritanium acetabular component of a total hip prosthesis is a new developed uncemented acetabular component. In this randomized controlled trial (RCT) the tritanium cup will be compared with the Trident HA acetabular component in two equal sized groups. The Symax HA coated stem will be used as femoral component in both groups.
Study Objectives:
Read more
- The primary objective is to determine the prosthetic migration of the uncemented acetabular and femoral total hip components using model based RSA technique
- Secondary objectives are on one hand to assess clinical outcome on the other hand assessing patient satisfaction in both groups using Harris Hip Score, Oxford Hip Score, WOMAC, and EQ-5D questionnaires
- Tertiary objective is to assess bone remodeling of the uncemented acetabular components and the HA-coated Symax hip stem using QCT derived from usinf F18-fluoride PET in a cohort of 12 consecutive patients of this RCT
A total of 50 patients will be enrolled in this RCT divided into two equal groups. Patients have to fulfill the inclusion and exclusion criteria.
All evaluations will be done pre-operatively with 2 weeks before surgery, and after surgery at 4 weeks, 3 and 6 months and 1 and 2 years.
- Conditions
- Osteoarthritis
- Being tested
- Tritanium acetabular component
- Keywords
- hipreplacement, uncemented, migration, boneremodeling
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tritanium acetabular componentDevice
Total hip arthroplasty using a tritanium uncemented acetabular component
| Study group | Role | What they receive |
|---|---|---|
| Tritanium cup | Experimental | Not described Receives: Device: Tritanium acetabular component |
| Trident HA cup | Active comparator | Not described Receives: Device: Tritanium acetabular component |
What is being measured
The primary outcome is the main question the study is designed to answer.
prosthetic migration of the uncemented acetabular and femoral total hip components
determine the prosthetic migration of the uncemented acetabular and femoral total hip components using model based RSA technique
Measured: 2 years
Secondary outcomes (1)
clinical outcome and patient satisfaction
assess clinical outcome and patient satisfaction in both groups using Harris Hip Score, Oxford Hip Score, WOMAC, and EQ-5D questionnaires
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startNov 2011
- Primary completionNov 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Orthopaedics
- Responsible party
- Sponsor
- Investigators
- Lodewijk Van Rhijn, professor, Principal investigator, Maastricht University Medical centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618084
- Sponsor's protocol ID
- MEC10-1-068
- Other IDs
- NL 33832.068.10
- Acronym
- RSA
- Status last verified
- Jun 2012
- First submitted
- 22 May 2012
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Rontgen Stereophotogrammatic Analysis (RSA) Study Using the Uncemented Trident Tritanium Acetabular Component and the Uncemented HA Coated Symax Hip Stem in a Single Centre: Assessment of Implant Migration, Bone Remodeling and Clinical Function
- ClinicalTrials.gov ID
- NCT01618084
- Acronym / sponsor ID
- RSA / MEC10-1-068
- Conditions
- Osteoarthritis
- Keywords
- hipreplacement, uncemented, migration, boneremodeling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Stryker Orthopaedics
- Study start
- Nov 2011
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 13 Jun 2012 (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 Trident Tritanium acetabular component of a total hip prosthesis is a new developed uncemented acetabular component. In this randomized controlled trial (RCT) the tritanium cup will be compared with the Trident HA acetabular component in two equal sized groups. The Symax HA coated stem will be used as femoral component in both groups.
Study Objectives:
- The primary objective is to determine the prosthetic migration of the uncemented acetabular and femoral total hip components using model based RSA technique
- Secondary objectives are on one hand to assess clinical outcome on the other hand assessing patient satisfaction in both groups using Harris Hip Score, Oxford Hip Score, WOMAC, and EQ-5D questionnaires
- Tertiary objective is to assess bone remodeling of the uncemented acetabular components and the HA-coated Symax hip stem using QCT derived from usinf F18-fluoride PET in a cohort of 12 consecutive patients of this RCT
A total of 50 patients will be enrolled in this RCT divided into two equal groups. Patients have to fulfill the inclusion and exclusion criteria.
All evaluations will be done pre-operatively with 2 weeks before surgery, and after surgery at 4 weeks, 3 and 6 months and 1 and 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tritanium cup | Experimental | Device: Tritanium acetabular component |
| Trident HA cup | Active comparator | Device: Tritanium acetabular component |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a BMI < 35
- Patients requiring uncemented primary THA
- Primary diagnosis of osteoarthritis
Key exclusion criteria (10 listed)
- patients with acetabular or femoral osteotomy
- Patients who had a THA on the contralateral side within last 6 months
- Female patients who are pregnant or planning pregnancy during the course of the study
- Patients with active or suspected infection
- patients with malignancy
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 |
|---|---|---|
| Tritanium acetabular componentTotal hip arthroplasty using a tritanium uncemented acetabular component | Device | Trident HA cup, Tritanium cup |
Primary outcome
prosthetic migration of the uncemented acetabular and femoral total hip components
Time frame: 2 years
determine the prosthetic migration of the uncemented acetabular and femoral total hip components using model based RSA technique
1 secondary outcome
clinical outcome and patient satisfaction
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2012.
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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.
Lodewijk Van Rhijn, professor principal investigator
Maastricht University Medical centre
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 Tritanium acetabular component in people with Osteoarthritis, run by Maastricht University Medical Center at 1 site in Netherlands.
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: status not confirmed, as of the sponsor's last update on 13 Jun 2012. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rene ten Broeke, MD (+31 43 387 5038, r.ten.broeke@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prosthetic migration of the uncemented acetabular and femoral total hip components (time frame: 2 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 13 Jun 2012.