Hip ReplacementCERAMNCT02062437
Clinical and Radiological Results of Total Hip Arthroplasty Using a Ceramic Friction Pair
An observational study of Hip Replacement and Primary, Secondary or Post-traumatic Osteoarthrosis, run by Stryker Trauma and Extremities.
Trial summary
The aim of this study is to assess safety and general performance of total hip arthroplasty, composed of a Meije Duo® femoral stem associated with a Dynacup® cup, and using the friction pair Biolox® Delta Ceramic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Replacement, Primary, Secondary or Post-traumatic Osteoarthrosis, Femur Head Necrosis
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Jan 2014
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort of European patients with a primary total hip replacement using a ceramic friction pair including Meije Duo® stem associated with a Dynacup® cup.
Who may be able to join
- Male or female patient implanted with a primary total hip replacement using a ceramic friction pair including Meije Duo® stem associated with a Dynacup® cup.
- Aged of more than 18 years at the time of the surgery.
- Patient with a follow-up of at least 2 years after surgery based on a consecutive and exhaustive series of patients operated within the inclusion period.
- Able to understand information to participate to the study.
Who cannot join
- Patient having a tumoral pathology.
- Patient having expressed opposition to the study participation.
About this study
Official title: Multicentric Observational Study Evaluating Clinical and Radiological Results of a Total Hip Arthroplasty Using a Ceramic Friction Pair
The aim of this study is to assess safety and general performance of total hip arthroplasty, composed of a Meije Duo® femoral stem associated with a Dynacup® cup, and using the friction pair Biolox® Delta Ceramic.
- Conditions
- Hip Replacement, Primary, Secondary or Post-traumatic Osteoarthrosis, Femur Head Necrosis, Congenital Dislocations
- Keywords
- Arthroplasty, Hip Replacement, Ceramic, Acetabular cup, Femoral stem
- Medical subject headings
- Neoplasm Metastasis, Femur Head Necrosis
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 |
|---|---|---|
| Total hip replacement using a ceramic friction pair | Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
- Surgical incidents.
- Post-operative complications.
- Failure and revisions analysis.
Measured: 2-year follow-up visit
Secondary outcomes (2)
General Performance: Mobility
Mobility of the hip is assessed by the maximum value in the range of motions, expressed in degrees (°).
Normal values (usually observed range of motions) are:
extension (from 0 to 30°), flexion (from 0 to 120°), abduction (from 0 to 45°), adduction (from 0 to 30°), external rotation (from 0 to 45°) and internal rotation (from 0 to 45°).
Higher values are the best and a negative value indicates that the patient(s) can't reach the minimum normal range of motion.
Measured: Baseline
General Performance: Mobility
Mobility of the hip is assessed by the maximum value in the range of motions, expressed in degrees (°).
Normal values (usually observed range of motions) are:
extension (from 0 to 30°), flexion (from 0 to 120°), abduction (from 0 to 45°), adduction (from 0 to 30°), external rotation (from 0 to 45°) and internal rotation (from 0 to 45°).
Higher values are the best and a negative value indicates that the patient(s) can't reach the minimum normal range of motion.
Measured: 2-year Follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startSep 2013
- Primary completionNov 2013
- Study completionJan 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 Hip ReplacementStudies of the same condition, open and under way.
- More trials run by Stryker Trauma and ExtremitiesThe 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Piriou, MD, Prof., Principal investigator, Hôpital Universitaire Raymond Poincaré, Garches - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062437
- Sponsor's protocol ID
- 1301-T-CERAM-R
- Acronym
- CERAM
- Status last verified
- May 2016
- First submitted
- 12 Feb 2014
- Last updated
- 31 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Observational Study Evaluating Clinical and Radiological Results of a Total Hip Arthroplasty Using a Ceramic Friction Pair
- ClinicalTrials.gov ID
- NCT02062437
- Acronym / sponsor ID
- CERAM / 1301-T-CERAM-R
- Conditions
- Hip Replacement, Primary, Secondary or Post-traumatic Osteoarthrosis, Femur Head Necrosis, Congenital Dislocations
- Keywords
- Arthroplasty, Hip Replacement, Ceramic, Acetabular cup, Femoral stem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Posted 28 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess safety and general performance of total hip arthroplasty, composed of a Meije Duo® femoral stem associated with a Dynacup® cup, and using the friction pair Biolox® Delta Ceramic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total hip replacement using a ceramic friction pair | – | –Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of European patients with a primary total hip replacement using a ceramic friction pair including Meije Duo® stem associated with a Dynacup® cup.
Key inclusion criteria (4 listed)
- Male or female patient implanted with a primary total hip replacement using a ceramic friction pair including Meije Duo® stem associated with a Dynacup® cup.
- Aged of more than 18 years at the time of the surgery.
- Patient with a follow-up of at least 2 years after surgery based on a consecutive and exhaustive series of patients operated within the inclusion period.
- Able to understand information to participate to the study.
Key exclusion criteria (2 listed)
- Patient having a tumoral pathology.
- Patient having expressed opposition to the study participation.
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
Number of Participants With Adverse Events
Time frame: 2-year follow-up visit
* Surgical incidents. * Post-operative complications. * Failure and revisions analysis.
2 secondary outcomes
General Performance: Mobility
Time frame: Baseline
General Performance: Mobility
Time frame: 2-year Follow-up visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Preoperative Muscle Stiffness, Functional Reserve, and Postoperative Quality of Recovery in Lower Extremity Arthroplasty
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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.
Philippe Piriou, MD, Prof. principal investigator
Hôpital Universitaire Raymond Poincaré, Garches - France
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Replacement and Primary, Secondary or Post-traumatic Osteoarthrosis, run by Stryker Trauma and Extremities.
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 2 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 31 May 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?
Yes. Results are posted in the registry (first posted 28 Apr 2016). 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?
Number of Participants With Adverse Events (time frame: 2-year follow-up visit). 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 31 May 2017.