Total Hip ResurfacingNCT00758355
Data Collection on ReCap/Magnum in Total Hip Replacement and Resurfacing
An observational study of Total Hip Resurfacing, run by Zimmer Biomet at 6 sites in France.
Trial summary
Observational study on ReCap/Magnum in Total Hip Replacement and Resurfacing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Resurfacing
- How many people
- 150 participants
- Where
- 6 sitesFrance
- Study dates
- Mar 2008to Jun 2016
- 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: Consecutive series of patients received Total Hip Replacement or Resurfacing with ReCap/Magnum for Their Respective Indications for Use/Intended Uses
Who may be able to join
- Consecutive series of patients received Total Hip Replacement or Resurfacing with ReCap/Magnum for Its Respective Indications for Use/Intended Uses
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU Amiens
Amiens, 80000
CHU Pellegrin Tripode
Bordeaux
CHU Hôpital Sud
Grenoble
Polyclinique de Hénin Beaumont
Hénin-Beaumont
Polyclinique de Riaumont
Liévin
Clinique Saint Andre
Reims
About this study
Official title: A Prospective, Multicentre Study Evaluating the Clinical Performance of the ReCap/Magnum in Total Hip Replacement and Resurfacing
Observational study on ReCap/Magnum in Total Hip Replacement and Resurfacing.
Read the detailed description
This observational study intends to collect efficacy and safety data on ReCap/Magnum in Total Hip Replacement and Resurfacing.
- Conditions
- Total Hip Resurfacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| M2A magnum | Consecutive series of patients received Total Hip Resurfacing with ReCap/Magnum | |
| Recap Magnum | Consecutive series of patients received Total Hip Replacement with ReCap/Magnum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postel-Merle d'Aubigné (PMA), Harris Hip Score
Measured: 1yr and 2yr
Secondary outcomes (2)
Complication
Measured: Any time
Survival
Measured: 1yr and 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 startMar 2008
- Primary completionDec 2013
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ResurfacingStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomet France SARL
- Responsible party
- Sponsor
- Investigators
- Dominique Saragaglia, Pr, Principal investigator, Hopital Sud - Echirolles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758355
- Sponsor's protocol ID
- BMETEU.CR.FR04
- Status last verified
- Jan 2017
- First submitted
- 23 Sep 2008
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre Study Evaluating the Clinical Performance of the ReCap/Magnum in Total Hip Replacement and Resurfacing
- ClinicalTrials.gov ID
- NCT00758355
- Acronym / sponsor ID
- BMETEU.CR.FR04
- Conditions
- Total Hip Resurfacing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Biomet France SARL
- Study start
- Mar 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2016 (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.
Observational study on ReCap/Magnum in Total Hip Replacement and Resurfacing.
Detailed description
This observational study intends to collect efficacy and safety data on ReCap/Magnum in Total Hip Replacement and Resurfacing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M2A magnum | – | –Consecutive series of patients received Total Hip Resurfacing with ReCap/Magnum |
| Recap Magnum | – | –Consecutive series of patients received Total Hip Replacement with ReCap/Magnum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive series of patients received Total Hip Replacement or Resurfacing with ReCap/Magnum for Their Respective Indications for Use/Intended Uses
Key inclusion criteria (1 listed)
- Consecutive series of patients received Total Hip Replacement or Resurfacing with ReCap/Magnum for Its Respective Indications for Use/Intended Uses
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.
Primary outcome
Postel-Merle d'Aubigné (PMA), Harris Hip Score
Time frame: 1yr and 2yr
2 secondary outcomes
Complication
Time frame: Any time
Survival
Time frame: 1yr and 2yr
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 23 Feb 2017.
Related trials for Total Hip Resurfacing
Recruiting
MOVE-HIP: Ceramic Hip Resurfacing Versus Total Hip Arthroplasty Using Activity Monitoring
Hip Osteoarthritis
Recruiting
The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement
Osteoarthritis, Hip, Inflammatory Arthritis
Active, not recruiting
Evaluate the Safety and Effectiveness of the Polymotion Hip Resurfacing (PHR) System Compared to Total Hip Arthroplasty
Osteoarthritis of the Hip, Degenerative Joint Disease of Hip
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.
Dominique Saragaglia, Pr principal investigator
Hopital Sud - Echirolles
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Resurfacing, run by Zimmer Biomet at 6 sites in France.
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: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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 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?
Postel-Merle d'Aubigné (PMA), Harris Hip Score (time frame: 1yr and 2yr). 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 23 Feb 2017.