OsteoarthritisPhase 4NCT00208403
A Randomised Single Centre Study to Compare the Long-term Performance of Acryloc™ and Palacos® R Bone Cements in Primary Total Hip Replacement
A Phase 4 study testing Acryloc™ GHV and Palacos R in people with Osteoarthritis and Post-traumatic Arthritis, run by DePuy International at 1 site in Norway.
Trial summary
The purpose of this study is to monitor the stability of a total hip replacement within the thigh bone when used in artificial hip joints implanted with two different bone cements, Acryloc™ and Palacos® R, in the treatment of patients with hip joint disease requiring a total hip replacement. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Osteoarthritis, Post-traumatic Arthritis, Avascular Necrosis
- What is being tested?
- Acryloc™ GHV and Palacos R
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2002to Oct 2005
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, aged 60 to 75 years (inclusive), and with a weight of less than 100kg.
- 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 with non-inflammatory arthritis of the hip.
- Subjects who require a primary total hip arthroplasty and are treated at the arthroplasty section of the orthopaedics department at the Investigational Centre.
- Subjects who are considered suitable for a cemented femoral stem and cemented acetabular component.
Who cannot join
- Subjects who, in the opinion of the Investigator, have an existing condition such as malignancy, severe osteoporosis, disabling musculo-skeletal problems (other than in the hips) or any other 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 undergoing corticosteroid treatment.
- Subjects with any condition for whom the use of conventional bone cement is contra-indicated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Prospective, RSA, PMS Study Comparing Acryloc™ & Palacos R in Primary Total Hip Arthroplasty
The purpose of this study is to monitor the stability of a total hip replacement within the thigh bone when used in artificial hip joints implanted with two different bone cements, Acryloc™ and Palacos® R, in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to Acryloc™ or Palacos® R and will be evaluated at regular intervals following hip surgery using patient, clinical, x-ray assessments and special x-rays which allow the stability of the hip implant to be determined
- Conditions
- Osteoarthritis, Post-traumatic Arthritis, Avascular Necrosis
- Being tested
- Acryloc™ GHV, Palacos R
- Keywords
- Hip, Cement
- Medical subject headings
- Osteoarthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acryloc™ GHVDevice
A high viscosity bone cement for use in total hip replacement
Palacos RDevice
A high viscosity bone cement for use in total hip replacement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Acryloc™ GHV Receives: Device: Acryloc™ GHV |
| 2 | Active comparator | Palacos R Receives: Device: Palacos R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distal migration of the femoral prosthesis from the time of implantation to the 2 year follow-up assessment
Measured: 2 Year
Secondary outcomes (4)
Annual posterior (AP) and medio-lateral (ML) RSA translations
Measured: Annually
Merle D'Aubigne score
Measured: Annually
Radiographic analysis
Measured: Annually
Kaplan-Meier Survivorship - Revision of any component for any reason
Measured: Throughout Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2002
- Primary completionOct 2005
- Study completionOct 2005
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
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208403
- Sponsor's protocol ID
- CT02/08
- Status last verified
- Mar 2017
- First submitted
- 13 Sep 2005
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Prospective, RSA, PMS Study Comparing Acryloc™ & Palacos R in Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00208403
- Acronym / sponsor ID
- CT02/08
- Conditions
- Osteoarthritis, Post-traumatic Arthritis, Avascular Necrosis
- Keywords
- Hip, Cement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 36 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 21 Sep 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 monitor the stability of a total hip replacement within the thigh bone when used in artificial hip joints implanted with two different bone cements, Acryloc™ and Palacos® R, in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to Acryloc™ or Palacos® R and will be evaluated at regular intervals following hip surgery using patient, clinical, x-ray assessments and special x-rays which allow the stability of the hip implant to be determined
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Acryloc™ GHVAcryloc™ GHV |
| 2 | Active comparator | Device: Palacos RPalacos R |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects, aged 60 to 75 years (inclusive), and with a weight of less than 100kg.
- 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 with non-inflammatory arthritis of the hip.
- Subjects who require a primary total hip arthroplasty and are treated at the arthroplasty section of the orthopaedics department at the Investigational Centre.
Key exclusion criteria (7 listed)
- Subjects who, in the opinion of the Investigator, have an existing condition such as malignancy, severe osteoporosis, disabling musculo-skeletal problems (other than in the hips) or any other 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 |
|---|---|---|
| Acryloc™ GHVA high viscosity bone cement for use in total hip replacement | Device | 1 |
| Palacos RA high viscosity bone cement for use in total hip replacement | Device | 2 |
Primary outcome
Distal migration of the femoral prosthesis from the time of implantation to the 2 year follow-up assessment
Time frame: 2 Year
4 secondary outcomes
Annual posterior (AP) and medio-lateral (ML) RSA translations
Time frame: Annually
Merle D'Aubigne score
Time frame: Annually
Radiographic analysis
Time frame: Annually
Kaplan-Meier Survivorship - Revision of any component for any reason
Time frame: Throughout Study
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acryloc™ GHV and Palacos R in people with Osteoarthritis and Post-traumatic Arthritis, run by DePuy International at 1 site in Norway.
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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 28 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 Norway. 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 was stopped early. Results are not available in the source record.
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?
Distal migration of the femoral prosthesis from the time of implantation to the 2 year follow-up assessment (time frame: 2 Year). 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 28 Mar 2017; AzTrials last refreshed its copy on 27 Oct 2026.