Arthroplasty, Hip, ReplacementNCT05044767
Study to Evaluate the Performance and Safety of ATF Implants and Lapé Médical Devices Implanted During Hip Arthroplasty
An observational study of Arthroplasty, Hip, Replacement, run by ATF Implants at 13 sites in France.
Trial summary
Observational and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty, Hip, Replacement
- What is being tested?
- total hip arthroplasty
- Type of treatment
- Medical device
- How many people
- 4,500 participants
- Where
- 13 sitesFrance
- Study dates
- 7 Jun 2021to 31 Dec 2032
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male or female indicated for hip replacement surgery with hip prosthesis manufactured by ATF Implants and/or Lapé médical.
Who may be able to join
- Male or female indicated for hip replacement surgery with hip prosthesis manufactured by ATF Implants and/or Lapé médical;
- There are different indications for hip replacement surgery. The main ones are listed below:
- Dysplasia
- Primary Coxarthrosis
- Secondary Coxarthrosis
- Perthes disease
Show all 17Show fewer
- Epiphysiolysis
- Ankylosing spondylitis
- Trochanteric bursitis
- Arthritis
- Degenerative arthritis
- Post-traumatic arthritis
- Rheumatoid arthritis
- Femoral neck fracture
- Osteonecrosis
- Revision
- Depending on the specificities of the devices (size, absence/presence of a coating, material), indications may vary. This information can be found in the instruction for use. It is the surgeon's responsibility to select the most appropriate prosthesis for a given patient according to the patient's medical records and the instruction for use in force at the time of the procedure accompanying the medical device.
Who cannot join
- There are various contraindications for hip arthroplasty. The main ones are listed below:
- An acute or chronic, local or systemic infection
- Severe muscular, neurological or vascular deficiency compromising the affected extremity
- A bone defect or insufficient bone quality that may compromise the stability of the implant
- Any concomitant disease (dysplastic coxarthrosis with extreme coxa valga, short neck and severe varus) that may affect the function of the implant
- Sensitivity to the material (allergy) Depending on the specificities of the devices (size, absence/presence of a coating, material), contraindications may vary. This information can be found in the instruction for use of the devices.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
France13 sites, 13 recruiting
- Not yet recruiting
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, 33076
Vincent Souillac, 556795544 ext. +33, vincent.souillac@chu-bordeaux.fr
Vincent Souillac, Dr
- Not yet recruiting
Clinique des Cèdres
Cornebarrieu, 31700
Jonathan Hourtal, 562133131 ext. +33, jonathanhourtal@gmail.com
Jonathan Hourtal, Dr
- Recruiting
Centre Ostéo-Articulaire des Cèdres
Échirolles, 38130
Jean-Claude Panisset, 476481485 ext. +33, dr.panisset@gmail.com
Jean-Claude Panisset, Dr
- Not yet recruiting
Hôpital privé Drôme Ardèche
Guilherand-Granges, 07500
Richard Philippe, 475823180 ext. +33, rphilippe@orange.fr
Richard Philippe, Dr
- Recruiting
Clinique du Croisé Laroche
Marcq-en-Barœul, 59700
Philippe Laffargue, 891650494 ext. +33, plaffargue@yahoo.fr
Philippe Laffargue, Prof
- Not yet recruiting
Polyclinique Saint George
Nice, 06100
Hervé Ovadia, 493817150 ext. +33, docteur@ovadia.fr
Hervé Ovadia, Dr
- Recruiting
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, 75020
Simon Marmor, 144641600 ext. +33, smarmor@hopital-dcss.org
Simon Marmor, Dr
- Recruiting
CHU de Poitiers
Poitiers, 86000
Pierre Bouget, 549444492 ext. +33, pbouget@hotmail.fr
Pierre Bouget, Dr
- Not yet recruiting
Clinique de l'Atlantique
Puilboreau, 17138
Cédric Bouquet, 536288500 ext. +33, docteurbouquet@gmail.com
Cédric Bouquet, Dr
- Not yet recruiting
CHU St Etienne, Hôpital Nord
Saint-Etienne, 42055
Frédéric Farizon, 477120372 ext. +33, frederic.farizon@chu-st-etienne.fr
Frédéric Farizon, Dr
- Recruiting
Polyclinique Sainte Thérèse
Sète, 34200
François Lozach, 467536286 ext. +33, francois.lozach@gmail.com
François Lozach, Dr
- Recruiting
Clinique de l'Orangerie
Strasbourg, 67000
David Dagrenat, 388360088 ext. +33, dagrenat.ortho@gmail.com
David Dagrenat, Dr
- Not yet recruiting
Hôpital privé du Vert Galant
Tremblay-en-France, 93290
Faouzi Madi, 826309393 ext. +33, faouzimadi2@gmail.com
Faouzi Madi, Dr
About this study
Official title: Observational and Prospective Multicenter Study to Evaluate the Long-term (10 Years) Performance and Safety (10 Years) of ATF Implants and Lapé Médical Devices Implanted During Total Hip Arthroplasty or Hemiarthroplasty.
Observational and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty.
Read the detailed description
Observational and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty.
The post-market clinical follow-up study to be conducted by ATF Implants following this plan aims to collect data from the follow-up of patients before and after hip replacement surgery with implants manufactured by ATF Implants and Lapé médical. In current practice, the surgeon-investigator evaluates the patient pre- and post-operatively according to predefined criteria used in orthopedic surgery and more particularly in hp replacement surgery. Complications and adverse effects observed are also recorded.
The main objective is to gather clinical evidence to evaluate the survival rate of ATP Implants and Lapé médical hip prostheses over the long-term, namely 10 years.
The secondary objectives are to evaluate the performance and safety of the prostheses over the same period (i.e. 10 years), as well as to obtain feedback on the performance /intended use and safety of the surgical instruments required for implant placement.
- Conditions
- Arthroplasty, Hip, Replacement
- 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
Also called hemiarthroplasty
hip replacement surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term survival rate
Long-term survival rate of the prostheses (10 years) with failure defined as revision surgery when considering all causes using Kaplan-Meier method.
Measured: 10 years
Secondary outcomes (1)
hip joint function
The evolution of hip joint function, and in this case the degree of physical disability before and after an intervention with Merle d'Aubigné score (PMA score) or Harris Hip Score (HHS score) or Parker score
Measured: before and after surgery (6 month, 2 years, 5 years, 7 years, 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start7 Jun 2021
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Hip, ReplacementStudies 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
- 4,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- ATF Implants
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Laffargue, Pr, Principal investigator, Clinique du Croisé Laroche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044767
- Sponsor's protocol ID
- PEPS
- Status last verified
- Jan 2023
- First submitted
- 6 Sep 2021
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational and Prospective Multicenter Study to Evaluate the Long-term (10 Years) Performance and Safety (10 Years) of ATF Implants and Lapé Médical Devices Implanted During Total Hip Arthroplasty or Hemiarthroplasty.
- ClinicalTrials.gov ID
- NCT05044767
- Acronym / sponsor ID
- PEPS
- Conditions
- Arthroplasty, Hip, Replacement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- ATF ImplantsIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 16 Sep 2021 (actual)
- 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 and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty.
Detailed description
Observational and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty.
The post-market clinical follow-up study to be conducted by ATF Implants following this plan aims to collect data from the follow-up of patients before and after hip replacement surgery with implants manufactured by ATF Implants and Lapé médical. In current practice, the surgeon-investigator evaluates the patient pre- and post-operatively according to predefined criteria used in orthopedic surgery and more particularly in hp replacement surgery. Complications and adverse effects observed are also recorded.
The main objective is to gather clinical evidence to evaluate the survival rate of ATP Implants and Lapé médical hip prostheses over the long-term, namely 10 years.
The secondary objectives are to evaluate the performance and safety of the prostheses over the same period (i.e. 10 years), as well as to obtain feedback on the performance /intended use and safety of the surgical instruments required for implant placement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male or female indicated for hip replacement surgery with hip prosthesis manufactured by ATF Implants and/or Lapé médical.
Key inclusion criteria (17 listed)
- Male or female indicated for hip replacement surgery with hip prosthesis manufactured by ATF Implants and/or Lapé médical;
- There are different indications for hip replacement surgery. The main ones are listed below:
- Dysplasia
- Primary Coxarthrosis
- Secondary Coxarthrosis
Key exclusion criteria (6 listed)
- There are various contraindications for hip arthroplasty. The main ones are listed below:
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 arthroplastyAlso: hemiarthroplastyhip replacement surgery | Device | – |
Primary outcome
Long-term survival rate
Time frame: 10 years
Long-term survival rate of the prostheses (10 years) with failure defined as revision surgery when considering all causes using Kaplan-Meier method.
1 secondary outcome
hip joint function
Time frame: before and after surgery (6 month, 2 years, 5 years, 7 years, 10 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
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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.
Philippe Laffargue, Pr principal investigator
Clinique du Croisé Laroche
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Hip, Replacement, run by ATF Implants at 13 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 17 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe Laffargue, Pr (891650494 ext. +33, plaffargue@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term survival rate (time frame: 10 years). 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 1 Feb 2023.