Arthropathy of HipNCT00859976
Study Comparing BoneMaster Hydroxyapatite Coating With Plasma-sprayed Hydroxyapatite Coating on Acetabular Cups
A study testing BoneMaster coated acetabular shell. and Plasma Coated Acetabular Shell in people with Arthropathy of Hip, run by Zimmer Biomet at 1 site in United Kingdom.
Trial summary
The randomised controlled trial will be carried out on patients that require a total hip replacement (THR) to reduce pain and restore their function. One way of fixing the hip joint to the bone is by coating the implant to encourage the body to grow bone onto the replacement hip. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthropathy of Hip
- What is being tested?
- BoneMaster coated acetabular shell. and Plasma Coated Acetabular Shell
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2009to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients suitable for THR surgery with a diagnosis of Osteoarthritis
- Patients aged 40 -85 years old.
- Patients with limited co-morbidity - ASA I - III (low risk for surgery)
- Patients must be able to understand instructions and be willing to return for follow up
Who cannot join
- Rheumatoid arthritis
- Patients requiring supplemental screw fixation
- Previous hip surgery to the affected hip
- Patients with significant co-morbidity - ASA IV - V (high risk for surgery)
- Dementia
- Neurological conditions affecting everyday functional ability and hip movement
Show all 10Show fewer
- The patient is unable to give informed consent
- Patients who have suffered from cancer
- The patient is currently part of another research study
- Patients who need to take Non Steroidal Anti-inflammatory Drugs (NSAIDs) in the first 6 weeks after surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomised Control Trial to Compare the Effect Upon Bone Density and Clinical Outcomes When Using BoneMaster HA Coated Acetabular Cups Compared With Plasma Sprayed HA Coated Cups in Patients With Total Hip Replacements
The randomised controlled trial will be carried out on patients that require a total hip replacement (THR) to reduce pain and restore their function. One way of fixing the hip joint to the bone is by coating the implant to encourage the body to grow bone onto the replacement hip. This study is aiming to find out whether the new (Bonemaster) coating allows increased bony growth onto the cup when compared to the usual (plasma-sprayed) coating. This may reduce the incidence of early failures due to poor bony attachment, which is a well known complication for early failure of total hip replacements.
The study will compare two different types of coating (BoneMaster and Plasma-sprayed) on the cup of the replacement hip. Density of the bone immediately surrounding the cup will be observed to see if there are differences between the two groups. The density of bone will be measured using standard x-ray assessment and in a smaller sample of 14 patients, using a special scan called Dual Energy X-ray Absorptiometry (DEXA Scan). Functional comparisons will be assessed through clinical scores.
Read the detailed description
The patients will be identified by the orthopaedic surgeon in the orthopaedic clinic and deemed suitable for the study if all inclusion and exclusion criteria are met. 210 patients will be recruited to the study and each patient will be randomised into either of the groups allowing 105 patients into each group. Patients will be followed up at 6 months, 1 year and 2 years after the surgery. All patients will have radiographic assessments at these follow-up intervals, as well as Harris Hip, Oxford Hip and Womac scores. This will allow comparison of the two groups.
The BoneMaster coating has been extensively tested in cell and animal studies and has been evaluated in one previous clinical study and showed favorable results. Further investigation is required to ensure the new coating may enhance bony growth allowing better fixation of the hips in the early period after the operation and also over a longer period of time. The growth needs to be measured using a more sensitive scan than radiographic assessment alone, called DEXA which was also used in the previous study.
- Conditions
- Arthropathy of Hip
- Being tested
- BoneMaster coated acetabular shell., Plasma Coated Acetabular Shell
- Keywords
- BoneMaster, Total Hip Replacement, Bone Density, Patients suitable for Total Hip Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoneMaster coated acetabular shell.Device
Also called Bonemaster coated Exceed Acetabular Shell
Bonemaster coated Exceed Acetabular Shell
Plasma Coated Acetabular ShellDevice
Also called Plasma Hydroxyapatite coated Exceed Acetabular Shell
Plasma HA coated Exceed Acetabular Shell
| Study group | Role | What they receive |
|---|---|---|
| Plasma-sprayed shell | Active comparator | Exceed ABT plasma-sprayed hydroxyapatite coated acetabular cup. Receives: Device: Plasma Coated Acetabular Shell |
| BoneMaster coated shell | Experimental | Exceed ABT BoneMaster hydroxyapatite coated acetabular cup. Receives: Device: BoneMaster coated acetabular shell. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Record and Measure Bone Density Using DEXA Scans at 24 Months.
DEXA scan cohort - DEXA scan was used to measure bone density. Below is the calculated net average bone mineral density (BMD) percentage change from baseline at 2 years.
Measured: 2 years.
Radiography to Determine Radiolucency in All Three DeLee & Charnley Zones of the Acetabulum.
34 patient cases without duplicated data were the basis for the radiographic analysis that was conducted: Bonemaster group, n = 12; Plasma-Sprayed group, n = 22. The degree of osseous-fixation was determined by grading: 1-2 mm radiolucencies, classed as not fixated; >2mm radiolucencies, classed as unstable.
Measured: 2 years.
Secondary outcomes (3)
Secondary Outcomes Are Functional Assessment Using Harris Hip Score
Modified Harris Hip Score, total score 0-100. A score of <70 is poor, 70-79 is fair, 80-89 is good, 90-100 is excellent.
Measured: 2 years
Secondary Outcomes Are Clinical Assessment Using Oxford Hip Score
Oxford Hip Score, scored 12-60. The Oxford hip score - this score was based on the original publication where each answer gives a score of 1-5. A score of 1 for each question, represented best outcome/least symptoms. Therefore a total score of 12 was the best overall outcome.
Measured: 2 years.
Secondary Outcomes Are Clinical Assessment Using WOMAC Hip Score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Hip Score, Each question is scored on a scale of 0 (best health state) to 4 (worst health state); total WOMAC hip score, 0 being the best and 96 being the worst.
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 posted11 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2012
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthropathy of HipStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helmut ZAHN, Principal investigator, William Harvey Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859976
- Sponsor's protocol ID
- BMETEU.CR.EU27
- Other IDs
- UK REC Ref: 08/H0724/24
- Status last verified
- Feb 2019
- First submitted
- 6 Mar 2009
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Control Trial to Compare the Effect Upon Bone Density and Clinical Outcomes When Using BoneMaster HA Coated Acetabular Cups Compared With Plasma Sprayed HA Coated Cups in Patients With Total Hip Replacements
- ClinicalTrials.gov ID
- NCT00859976
- Acronym / sponsor ID
- BMETEU.CR.EU27
- Conditions
- Arthropathy of Hip
- Keywords
- BoneMaster, Total Hip Replacement, Bone Density, Patients suitable for Total Hip Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 11 Mar 2009 (estimated)
- Results
- Posted 8 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The randomised controlled trial will be carried out on patients that require a total hip replacement (THR) to reduce pain and restore their function. One way of fixing the hip joint to the bone is by coating the implant to encourage the body to grow bone onto the replacement hip. This study is aiming to find out whether the new (Bonemaster) coating allows increased bony growth onto the cup when compared to the usual (plasma-sprayed) coating. This may reduce the incidence of early failures due to poor bony attachment, which is a well known complication for early failure of total hip replacements.
The study will compare two different types of coating (BoneMaster and Plasma-sprayed) on the cup of the replacement hip. Density of the bone immediately surrounding the cup will be observed to see if there are differences between the two groups. The density of bone will be measured using standard x-ray assessment and in a smaller sample of 14 patients, using a special scan called Dual Energy X-ray Absorptiometry (DEXA Scan). Functional comparisons will be assessed through clinical scores.
Detailed description
The patients will be identified by the orthopaedic surgeon in the orthopaedic clinic and deemed suitable for the study if all inclusion and exclusion criteria are met. 210 patients will be recruited to the study and each patient will be randomised into either of the groups allowing 105 patients into each group. Patients will be followed up at 6 months, 1 year and 2 years after the surgery. All patients will have radiographic assessments at these follow-up intervals, as well as Harris Hip, Oxford Hip and Womac scores. This will allow comparison of the two groups.
The BoneMaster coating has been extensively tested in cell and animal studies and has been evaluated in one previous clinical study and showed favorable results. Further investigation is required to ensure the new coating may enhance bony growth allowing better fixation of the hips in the early period after the operation and also over a longer period of time. The growth needs to be measured using a more sensitive scan than radiographic assessment alone, called DEXA which was also used in the previous study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasma-sprayed shell | Active comparator | Device: Plasma Coated Acetabular ShellExceed ABT plasma-sprayed hydroxyapatite coated acetabular cup. |
| BoneMaster coated shell | Experimental | Device: BoneMaster coated acetabular shell.Exceed ABT BoneMaster hydroxyapatite coated acetabular cup. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients suitable for THR surgery with a diagnosis of Osteoarthritis
- Patients aged 40 -85 years old.
- Patients with limited co-morbidity - ASA I - III (low risk for surgery)
- Patients must be able to understand instructions and be willing to return for follow up
Key exclusion criteria (10 listed)
- Rheumatoid arthritis
- Patients requiring supplemental screw fixation
- Previous hip surgery to the affected hip
- Patients with significant co-morbidity - ASA IV - V (high risk for surgery)
- Dementia
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 |
|---|---|---|
| BoneMaster coated acetabular shell.Also: Bonemaster coated Exceed Acetabular ShellBonemaster coated Exceed Acetabular Shell | Device | BoneMaster coated shell |
| Plasma Coated Acetabular ShellAlso: Plasma Hydroxyapatite coated Exceed Acetabular ShellPlasma HA coated Exceed Acetabular Shell | Device | Plasma-sprayed shell |
Primary outcome
Record and Measure Bone Density Using DEXA Scans at 24 Months.
Time frame: 2 years.
DEXA scan cohort - DEXA scan was used to measure bone density. Below is the calculated net average bone mineral density (BMD) percentage change from baseline at 2 years.
Radiography to Determine Radiolucency in All Three DeLee & Charnley Zones of the Acetabulum.
Time frame: 2 years.
34 patient cases without duplicated data were the basis for the radiographic analysis that was conducted: Bonemaster group, n = 12; Plasma-Sprayed group, n = 22. The degree of osseous-fixation was determined by grading: 1-2 mm radiolucencies, classed as not fixated; >2mm radiolucencies, classed as unstable.
3 secondary outcomes
Secondary Outcomes Are Functional Assessment Using Harris Hip Score
Time frame: 2 years
Secondary Outcomes Are Clinical Assessment Using Oxford Hip Score
Time frame: 2 years.
Secondary Outcomes Are Clinical Assessment Using WOMAC Hip Score
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Helmut ZAHN principal investigator
William Harvey Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BoneMaster coated acetabular shell. and Plasma Coated Acetabular Shell in people with Arthropathy of Hip, run by Zimmer Biomet at 1 site in United Kingdom.
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 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 Mar 2019. 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 United Kingdom. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Record and Measure Bone Density Using DEXA Scans at 24 Months. (time frame: 2 years.). The study lists 2 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 Mar 2019; AzTrials last refreshed its copy on 27 Oct 2026.