Arthropathy of HipNCT01684631
Evaluation of Implant Survival in Patients With a Pinnacle Ultamet Device in Conventional Total Hip Joint Replacement
An observational study of Arthropathy of Hip, run by DePuy International at 6 sites in France.
Trial summary
The objective is to evaluate the implant survival rate for patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease and true femoral cervical fracture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthropathy of Hip
- What is being tested?
- Total Hip arthroplasty
- Type of treatment
- Medical device
- How many people
- 107 participants
- Where
- 6 sitesFrance
- Study dates
- Jan 2009to Dec 2015
- 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 susceptible to receive a PINNACLE® ULTAMET™ implant
Who may be able to join
- Patients susceptible to receive a PINNACLE® ULTAMET™ implant as per routine practice
Who cannot join
- Patient refusal to participate to the data collection
- Pregnant woman
- Patients age is less than 18 years old
- The planned intervention is a revision of a previous intervention on the studied hip joint
- Previous metal implant, except for pure titanium or titanium alloys
- Exposure to cobalt and chromium that could influence serum metal ions levels
Show all 9Show fewer
- Planned bilateral intervention
- Patient residing outside France
- Patient not implanted with a Pinnacle(R) ULTAMET(TM)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Clinique Herbert
Aix-les-Bains, 73100
Clinique Bonnefon
Alès, 30104
Centre Hospitalier Georges Renon
Niort, 79021
Clinique Saint Hilaire
Rouen, 76000
Clinique Pasteur
Royan, 17200
Clinique Mutualiste Saint Etienne
Saint-Etienne, 42013
About this study
Official title: Prospective, Multicentric, Observational Cohort Study for the Evaluation of Implant Survival in Patients With a Metal-on-Metal Pinnacle(R) Ultamet(TM) Device in Conventional Total Hip Joint Replacement.
The objective is to evaluate the implant survival rate for patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease and true femoral cervical fracture.
- Conditions
- Arthropathy of Hip
- Being tested
- Total Hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip arthroplastyDevice
| Study group | Role | What they receive |
|---|---|---|
| Hip arthroplasty | Patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease or true femoral cervical fracture. Receives: Device: Total Hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survival Rate
Implant Survival Rate as the duration of PINNACLE® ULTAMET™ implantation for the follow-up duration, free of revision surgery, whatever the cause.
Measured: up to 5 years
Secondary outcomes (1)
Harris Hip Score
Measure of hip function using the Harris Hip Score
Measured: pre-operative, 1, 2, 3, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startJan 2009
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthropathy of HipStudies of the same condition, open and under way.
- 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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Marie Toupin, MD, Principal investigator, Clinique Saint Hilaire Rouen, France 76000
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684631
- Sponsor's protocol ID
- 27062008
- Status last verified
- Sep 2016
- First submitted
- 11 Sep 2012
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am. 1969 Jun;51(4):737-55. No abstract available.
PubMed 5783851
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentric, Observational Cohort Study for the Evaluation of Implant Survival in Patients With a Metal-on-Metal Pinnacle(R) Ultamet(TM) Device in Conventional Total Hip Joint Replacement.
- ClinicalTrials.gov ID
- NCT01684631
- Acronym / sponsor ID
- 27062008
- Conditions
- Arthropathy of Hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Sep 2012 (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.
The objective is to evaluate the implant survival rate for patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease and true femoral cervical fracture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hip arthroplasty | – | Device: Total Hip arthroplastyPatients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease or true femoral cervical fracture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients susceptible to receive a PINNACLE® ULTAMET™ implant
Key inclusion criteria (1 listed)
- Patients susceptible to receive a PINNACLE® ULTAMET™ implant as per routine practice
Key exclusion criteria (9 listed)
- Patient refusal to participate to the data collection
- Pregnant woman
- Patients age is less than 18 years old
- The planned intervention is a revision of a previous intervention on the studied hip joint
- Previous metal implant, except for pure titanium or titanium alloys
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 |
|---|---|---|
| Total Hip arthroplasty | Device | Hip arthroplasty |
Primary outcome
Implant Survival Rate
Time frame: up to 5 years
Implant Survival Rate as the duration of PINNACLE® ULTAMET™ implantation for the follow-up duration, free of revision surgery, whatever the cause.
1 secondary outcome
Harris Hip Score
Time frame: pre-operative, 1, 2, 3, 5 years
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 26 Sep 2016.
- Background: PubMed 5783851Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am. 1969 Jun;51(4):737-55. No abstract available.
Related trials for Arthropathy of Hip
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
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.
Jean-Marie Toupin, MD principal investigator
Clinique Saint Hilaire Rouen, France 76000
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 Arthropathy of Hip, run by DePuy International 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 9 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 26 Sep 2016. 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?
Implant Survival Rate (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01684631, which also lists 1 linked publication.
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 26 Sep 2016.