Rheumatoid ArthritisPhase 4NCT00872066
A Study to Assess the Long-term Performance of SmartSet® HV and SmartSet® GHV Bone Cements in Primary Total Hip Replacement
A Phase 4 study testing SmartSet® HV bone cement and SmartSet® GHV bone cement in people with Rheumatoid Arthritis and Osteoarthritis, run by DePuy International at 1 site in Slovakia.
Trial summary
The purpose of this study is to monitor the performance of artificial hip joints implanted with two different bone cements, SmartSet® HV and SmartSet® GHV, in the treatment of patients with hip joint disease requiring a total hip replacement. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis
- What is being tested?
- SmartSet® HV bone cement and SmartSet® GHV bone cement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 1 siteSlovakia
- Study dates
- Mar 2006to Jul 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, aged between 18 and 75 years (inclusive).
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects requiring primary total hip arthroplasty and are considered suitable for a cemented femoral component.
Who cannot join
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
- Subjects who are currently involved in any injury litigation claims.
- Subjects with contraindications normally applicable to the use of conventional bone cement, in accordance with the manufacturer's Instructions For Use.
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
Orthopaedic-traumatology Clinic University Hospital Martin
Martin
About this study
Official title: A Prospective, Randomised, Uncontrolled, Single-Centre, Post-Market Surveillance Study To Evaluate The Performance Of SmartSet® HV and SmartSet® GHV Bone Cements In Primary Cemented Total Hip Arthroplasty(THA)
The purpose of this study is to monitor the performance of artificial hip joints implanted with two different bone cements, SmartSet® HV and SmartSet® GHV, in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to SmartSet® HV or SmartSet® GHV and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Traumatic Femoral Fractures
- Being tested
- SmartSet® HV bone cement, SmartSet® GHV bone cement
- Keywords
- Hip, Bone Cement
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis, Collagen Diseases, Osteonecrosis, Hip Dislocation, Congenital, Slipped Capital Femoral Epiphyses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartSet® HV bone cementDevice
A high viscosity bone cement for use in total hip replacement (without gentamicin)
SmartSet® GHV bone cementDevice
A high viscosity bone cement for use in total hip replacement (with gentamicin)
| Study group | Role | What they receive |
|---|---|---|
| 1) SmartSet® HV Bone Cement | Active comparator | A high viscosity bone cement for use in total hip replacement (without gentamicin) Receives: Device: SmartSet® HV bone cement |
| 2) SmartSet® GHV Bone Cement | Active comparator | A high viscosity bone cement for use in total hip replacement (with gentamicin) Receives: Device: SmartSet® GHV bone cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kaplan-Meier survivorship
Measured: Annually
Secondary outcomes (3)
Harris Hip Score
Measured: Annually
Oxford Hip Score
Measured: Annually
Radiological Analysis
Measured: Annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startMar 2006
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- None (open label)
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Libor Nečas, M.D., Principal investigator, Orthopaedic-truamatology Clinic, University Hospital Martin, Slovakia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872066
- Sponsor's protocol ID
- CT02/11
- Status last verified
- Mar 2017
- First submitted
- 19 Mar 2009
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Uncontrolled, Single-Centre, Post-Market Surveillance Study To Evaluate The Performance Of SmartSet® HV and SmartSet® GHV Bone Cements In Primary Cemented Total Hip Arthroplasty(THA)
- ClinicalTrials.gov ID
- NCT00872066
- Acronym / sponsor ID
- CT02/11
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Traumatic Femoral Fractures
- Keywords
- Hip, Bone Cement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 31 Mar 2009 (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 monitor the performance of artificial hip joints implanted with two different bone cements, SmartSet® HV and SmartSet® GHV, in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to SmartSet® HV or SmartSet® GHV and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1) SmartSet® HV Bone Cement | Active comparator | Device: SmartSet® HV bone cementA high viscosity bone cement for use in total hip replacement (without gentamicin) |
| 2) SmartSet® GHV Bone Cement | Active comparator | Device: SmartSet® GHV bone cementA high viscosity bone cement for use in total hip replacement (with gentamicin) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects, aged between 18 and 75 years (inclusive).
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects requiring primary total hip arthroplasty and are considered suitable for a cemented femoral component.
Key exclusion criteria (6 listed)
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
- Subjects who are currently involved in any injury litigation claims.
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 |
|---|---|---|
| SmartSet® HV bone cementA high viscosity bone cement for use in total hip replacement (without gentamicin) | Device | 1) SmartSet® HV Bone Cement |
| SmartSet® GHV bone cementA high viscosity bone cement for use in total hip replacement (with gentamicin) | Device | 2) SmartSet® GHV Bone Cement |
Primary outcome
Kaplan-Meier survivorship
Time frame: Annually
3 secondary outcomes
Harris Hip Score
Time frame: Annually
Oxford Hip Score
Time frame: Annually
Radiological Analysis
Time frame: Annually
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 3 Mar 2017.
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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.
Libor Nečas, M.D. principal investigator
Orthopaedic-truamatology Clinic, University Hospital Martin, Slovakia
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 SmartSet® HV bone cement and SmartSet® GHV bone cement in people with Rheumatoid Arthritis and Osteoarthritis, run by DePuy International at 1 site in Slovakia.
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 6 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 3 Mar 2017. 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 Slovakia. 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?
Kaplan-Meier survivorship (time frame: Annually). 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 3 Mar 2017.