Osteoarthritis of the HipNCT00758329
Retrospective Data Review of ReCap Total Hip Resurfacing
An observational study of Osteoarthritis of the Hip, run by Zimmer Biomet.
Trial summary
Retrospective Data Review on clinical outcomes and 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
- Osteoarthritis of the Hip
- What is being tested?
- ReCap Total Hip Resurfacing
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Apr 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 who received ReCap Total Hip Resurfacing
Who may be able to join
- Patients received ReCap total hip resurfacing
Who cannot join
None listed.
About this study
Retrospective Data Review on clinical outcomes and survivorship of ReCap Total Hip Resurfacing
- Conditions
- Osteoarthritis of the Hip
- Being tested
- ReCap Total Hip Resurfacing
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReCap Total Hip ResurfacingDevice
ReCap Total Hip Resurfacing
| Study group | Role | What they receive |
|---|---|---|
| 1 | 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: 2 yr
Secondary outcomes (1)
Harris Hip Score
Measured: 2yr
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 startApr 2004
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: No further contact with the site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomet U.K. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758329
- Sponsor's protocol ID
- BMET UK 09
- 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
- Retrospective Data Review of ReCap Total Hip Resurfacing
- ClinicalTrials.gov ID
- NCT00758329
- Acronym / sponsor ID
- BMET UK 09
- Conditions
- Osteoarthritis of the Hip
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No further contact with the site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Biomet U.K. Ltd.
- Study start
- Apr 2004
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 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.
Retrospective Data Review on clinical outcomes and survivorship of ReCap Total Hip Resurfacing
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | 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 who received ReCap Total Hip Resurfacing
Key inclusion criteria (1 listed)
- Patients received ReCap total hip resurfacing
Key exclusion criteria (0 listed)
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 ResurfacingReCap Total Hip Resurfacing | Device | 1 |
Primary outcome
Survival rate
Time frame: 2 yr
1 secondary outcome
Harris Hip Score
Time frame: 2yr
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis of the Hip, run by Zimmer Biomet.
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 0 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: withdrawn, 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.
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 withdrawn before enrolling participants, so there are no results.
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: 2 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.