ArthritisNCT00758472
ReCap Total Hip Resurfacing Prospective Data Collection
An observational study of Arthritis, run by Zimmer Biomet at 2 sites in United Kingdom.
Trial summary
Prospective data collection on survivorship of ReCap Total Hip Resurfacing Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis
- What is being tested?
- ReCap Total Hip Resurfacing
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Mar 2005to Mar 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suitable for Total Hip Resurfacing
Who may be able to join
- Clinical diagnosis of hip joint arthritis
Who cannot join
- less than 18 years of age
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Southmead Hospital
Bristol
Robert Jones & Agnes Hunt Orthopaedic & District Hospital NHS Trust
Oswestry
About this study
Prospective data collection on survivorship of ReCap Total Hip Resurfacing
Read the detailed description
Detailed protocol not available
- Conditions
- Arthritis
- Being tested
- ReCap Total Hip Resurfacing
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReCap Total Hip ResurfacingDevice
Also called RECAP
ReCap Total Hip Resurfacing
| Study group | Role | What they receive |
|---|---|---|
| Hip Resurfacing | Not described Receives: Device: ReCap Total Hip Resurfacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
Measured: 10 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startMar 2005
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomet U.K. Ltd.
- Responsible party
- Sponsor
- Investigators
- Evert Smith, MD, Principal investigator, North Bristol NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758472
- Sponsor's protocol ID
- BMET UK 08
- Status last verified
- Jun 2017
- First submitted
- 23 Sep 2008
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReCap Total Hip Resurfacing Prospective Data Collection
- ClinicalTrials.gov ID
- NCT00758472
- Acronym / sponsor ID
- BMET UK 08
- Conditions
- Arthritis
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Biomet U.K. Ltd.
- Study start
- Mar 2005
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 25 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.
Prospective data collection on survivorship of ReCap Total Hip Resurfacing
Detailed description
Detailed protocol not available
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hip Resurfacing | – | Device: ReCap Total Hip Resurfacing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suitable for Total Hip Resurfacing
Key inclusion criteria (1 listed)
- Clinical diagnosis of hip joint arthritis
Key exclusion criteria (1 listed)
- less than 18 years of age
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 |
|---|---|---|
| ReCap Total Hip ResurfacingAlso: RECAPReCap Total Hip Resurfacing | Device | Hip Resurfacing |
Primary outcome
survival rate
Time frame: 10 yr
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 19 Jun 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.
Evert Smith, MD principal investigator
North Bristol NHS Trust
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 Arthritis, run by Zimmer Biomet at 2 sites 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 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: stopped early, as of the sponsor's last update on 19 Jun 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 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?
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?
survival rate (time frame: 10 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 19 Jun 2017.