CoxarthrosisPhase 4NCT00159497
Bone Remodeling Around HA-coated Acetabular Cups.
A Phase 4 study testing porous coated Trilogy® and Trilogy Calcicoat® in people with Coxarthrosis, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
This study was designed to investigate the influence of HA-coating on bone remodeling around the cup in cementless THA. 100 patients gave informed consent to participate in a controlled randomized study between porous coated Trilogy® versus Trilogy Calcicoat®. The cup was inserted in press-fit fixation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coxarthrosis
- What is being tested?
- porous coated Trilogy® and Trilogy Calcicoat®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 1998to Jan 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for cementless THA
Who cannot join
- Medical conditions interfering with bone metabolism
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Northern Orthopaedic Division, Klinik Farsoe, Aalborg University Hospital
Farsø, Northern Jutland
About this study
This study was designed to investigate the influence of HA-coating on bone remodeling around the cup in cementless THA.
100 patients gave informed consent to participate in a controlled randomized study between porous coated Trilogy® versus Trilogy Calcicoat®. The cup was inserted in press-fit fixation. The femoral component was a cementless porous coated titanium alloy stem (Bi-Metric®), with a modular 28 mm CrCo head. Effect parameters were Harris Hip Score (HHS) and Bone Mineral Density (BMD) determined by DEXA scanning.
Measurements revealed no difference between the two groups after 3 years, neither in clinical outcome nor in terms of periprosthetic bone density. Patients with Body Mass Index above normal regained more bone mineral than patients with normal weight. This finding supports the assumption that load is beneficial to bone remodeling. Advantages of better sealing of the bone-prosthesis interface, preventing polyethylene induced osteolysis, may still be anticipated for the 7 or 12 year follow-up examinations
Read the detailed description
This study was designed to investigate the influence of HA-coating on bone remodeling around the cup in cementless THA.
100 patients gave informed consent to participate in a controlled randomized study between porous coated Trilogy® versus Trilogy Calcicoat®. The cup was inserted in press-fit fixation. The femoral component was a cementless porous coated titanium alloy stem (Bi-Metric®), with a modular 28 mm CrCo head. Effect parameters were Harris Hip Score (HHS) and Bone Mineral Density (BMD) determined by DEXA scanning.
Measurements revealed no difference between the two groups after 3 years, neither in clinical outcome nor in terms of periprosthetic bone density. Patients with Body Mass Index above normal regained more bone mineral than patients with normal weight. This finding supports the assumption that load is beneficial to bone remodeling. Advantages of better sealing of the bone-prosthesis interface, preventing polyethylene induced osteolysis, may still be anticipated for the 7 or 12 year follow-up examinations
- Conditions
- Coxarthrosis
- Being tested
- porous coated Trilogy®, Trilogy Calcicoat®
- Keywords
- THA
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
porous coated Trilogy®Device
Also called Zimmer
THA
Trilogy Calcicoat®Device
Also called Zimmer
THA
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Standard porouscoated Trilogy Cup Receives: Device: porous coated Trilogy® |
| 2 | Experimental | HA coated Trilogy cup Receives: Device: Trilogy Calcicoat® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bone mineral density around the hip prosthesis, measured by DEXA scanning
Measured: 8-12 years
Secondary outcomes (1)
Changes in hip performance, measured by Harris Hip Score
Measured: 8-12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startOct 1998
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoxarthrosisStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mogens B Laursen, MD, Principal investigator, Northern Orthopaedic Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159497
- Sponsor's protocol ID
- ON-04-001-MBL
- Status last verified
- Mar 2014
- First submitted
- 9 Sep 2005
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Remodeling Around HA-coated Acetabular Cups.
- ClinicalTrials.gov ID
- NCT00159497
- Acronym / sponsor ID
- ON-04-001-MBL
- Conditions
- Coxarthrosis
- Keywords
- THA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Oct 1998
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 12 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.
This study was designed to investigate the influence of HA-coating on bone remodeling around the cup in cementless THA.
100 patients gave informed consent to participate in a controlled randomized study between porous coated Trilogy® versus Trilogy Calcicoat®. The cup was inserted in press-fit fixation. The femoral component was a cementless porous coated titanium alloy stem (Bi-Metric®), with a modular 28 mm CrCo head. Effect parameters were Harris Hip Score (HHS) and Bone Mineral Density (BMD) determined by DEXA scanning.
Measurements revealed no difference between the two groups after 3 years, neither in clinical outcome nor in terms of periprosthetic bone density. Patients with Body Mass Index above normal regained more bone mineral than patients with normal weight. This finding supports the assumption that load is beneficial to bone remodeling. Advantages of better sealing of the bone-prosthesis interface, preventing polyethylene induced osteolysis, may still be anticipated for the 7 or 12 year follow-up examinations
Detailed description
This study was designed to investigate the influence of HA-coating on bone remodeling around the cup in cementless THA.
100 patients gave informed consent to participate in a controlled randomized study between porous coated Trilogy® versus Trilogy Calcicoat®. The cup was inserted in press-fit fixation. The femoral component was a cementless porous coated titanium alloy stem (Bi-Metric®), with a modular 28 mm CrCo head. Effect parameters were Harris Hip Score (HHS) and Bone Mineral Density (BMD) determined by DEXA scanning.
Measurements revealed no difference between the two groups after 3 years, neither in clinical outcome nor in terms of periprosthetic bone density. Patients with Body Mass Index above normal regained more bone mineral than patients with normal weight. This finding supports the assumption that load is beneficial to bone remodeling. Advantages of better sealing of the bone-prosthesis interface, preventing polyethylene induced osteolysis, may still be anticipated for the 7 or 12 year follow-up examinations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: porous coated Trilogy®Standard porouscoated Trilogy Cup |
| 2 | Experimental | Device: Trilogy Calcicoat®HA coated Trilogy cup |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients eligible for cementless THA
Key exclusion criteria (1 listed)
- Medical conditions interfering with bone metabolism
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 |
|---|---|---|
| porous coated Trilogy®Also: ZimmerTHA | Device | 1 |
| Trilogy Calcicoat®Also: ZimmerTHA | Device | 2 |
Primary outcome
Changes in bone mineral density around the hip prosthesis, measured by DEXA scanning
Time frame: 8-12 years
1 secondary outcome
Changes in hip performance, measured by Harris Hip Score
Time frame: 8-12 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 31 Mar 2014.
- The final paper from this trial.Link provided by the sponsor.
Related trials for Coxarthrosis
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Post-Market Clinical Follow-up of Intra-Articular Hyaluronic Acid in Hip Osteoarthritis
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Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
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Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Not yet recruiting
DEXA Bone Density Analysis of the CoreHip® Prosthesis System
Primary Osteoarthritis, Cartilage Degeneration
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.
Mogens B Laursen, MD principal investigator
Northern Orthopaedic Division
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 porous coated Trilogy® and Trilogy Calcicoat® in people with Coxarthrosis, run by Northern Orthopaedic Division, Denmark 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 1 inclusion and 1 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 31 Mar 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?
Changes in bone mineral density around the hip prosthesis, measured by DEXA scanning (time frame: 8-12 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 31 Mar 2014.