OsteoarthritisNCT00755001
Clinical Study on BiHapro Total Hip System With Different Surface Coatings
An observational study of Osteoarthritis, run by Zimmer Biomet at 2 sites in Spain.
Trial summary
This post market study intends to evaluate the safety and the performance of BiHapro Total Hip System with two types of coatings. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- BiHapro hip stem with PPS Ti+Plasma HA and BiHapro hip stem with PPS Ti+BoneMaster HA
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 2 sitesSpain
- Study dates
- May 2007to May 2011
- Phase
- Observational
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Total Hip Arthroplasty
The patients who are selected for this study must fit the following criteria.
- Candidate for a Total Hip Arthroplasty
- Less than 80 years of age.
- A pre-operative level of pain and function the same as for conventional joint replacement.
- A likelihood of obtaining relief of pain and improved function.
- Full skeletal maturity.
- Ability to follow instructions.
- Good general health for age.
- Willing to return for follow-up evaluations.
- No bias to sex.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
University Hospital of Aviles
Avilés
University Central Hospital of Asturias
Oviedo
About this study
This post market study intends to evaluate the safety and the performance of BiHapro Total Hip System with two types of coatings.
Read the detailed description
The efficacy of the prosthesis will be evaluated comparing the pain, the function and the range of motion measured preoperatively and postoperatively using recognized clinical outcomes Harris Hip Score. The secondary efficacy measurement is based on X-rays to measure the mineral bony thickness in the areas of Gruen zones of the proximal femur.
- Conditions
- Osteoarthritis
- Being tested
- BiHapro hip stem with PPS Ti+Plasma HA, BiHapro hip stem with PPS Ti+BoneMaster HA
- Keywords
- Total Hip Replacement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiHapro hip stem with PPS Ti+Plasma HADevice
Also called BiHapro hip stem
BiHapro hip stem with PPS Ti+Plasma HA
BiHapro hip stem with PPS Ti+BoneMaster HADevice
Also called BiHapro hip stem
BiHapro hip stem with PPS Ti+BoneMaster HA
| Study group | Role | What they receive |
|---|---|---|
| with Plasma HA | BiHapro Hip stem with PPS Ti + Plasma HA Receives: Device: BiHapro hip stem with PPS Ti+Plasma HA | |
| with BoneMaster HA | BiHapro Hip stem with PPS Ti + BoneMaster HA Receives: Device: BiHapro hip stem with PPS Ti+BoneMaster HA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
Measured: annual at least to 5 yr
Secondary outcomes (1)
Radiographic Assessment
Measured: Annual; At least to 5 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startMay 2007
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: The site decided to stop the study
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomet Spain Orthopaedics S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755001
- Sponsor's protocol ID
- BMET EP 01
- Status last verified
- Jul 2017
- First submitted
- 16 Sep 2008
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on BiHapro Total Hip System With Different Surface Coatings
- ClinicalTrials.gov ID
- NCT00755001
- Acronym / sponsor ID
- BMET EP 01
- Conditions
- Osteoarthritis
- Keywords
- Total Hip Replacement
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The site decided to stop the study
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Biomet Spain Orthopaedics S.L.
- Study start
- May 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 18 Sep 2008 (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 post market study intends to evaluate the safety and the performance of BiHapro Total Hip System with two types of coatings.
Detailed description
The efficacy of the prosthesis will be evaluated comparing the pain, the function and the range of motion measured preoperatively and postoperatively using recognized clinical outcomes Harris Hip Score. The secondary efficacy measurement is based on X-rays to measure the mineral bony thickness in the areas of Gruen zones of the proximal femur.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with Plasma HA | – | Device: BiHapro hip stem with PPS Ti+Plasma HABiHapro Hip stem with PPS Ti + Plasma HA |
| with BoneMaster HA | – | Device: BiHapro hip stem with PPS Ti+BoneMaster HABiHapro Hip stem with PPS Ti + BoneMaster HA |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Total Hip Arthroplasty
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 |
|---|---|---|
| BiHapro hip stem with PPS Ti+Plasma HAAlso: BiHapro hip stemBiHapro hip stem with PPS Ti+Plasma HA | Device | with Plasma HA |
| BiHapro hip stem with PPS Ti+BoneMaster HAAlso: BiHapro hip stemBiHapro hip stem with PPS Ti+BoneMaster HA | Device | with BoneMaster HA |
Primary outcome
Harris Hip Score
Time frame: annual at least to 5 yr
1 secondary outcome
Radiographic Assessment
Time frame: Annual; At least to 5 yr
Results and safety
The study was stopped early (reason given: The site decided to stop the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Zimmer Biomet at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
The study was stopped early (reason given: The site decided to stop the study). 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?
Harris Hip Score (time frame: annual at least to 5 yr). 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 7 Jul 2017.