Total Hip ReplacementNCT06628336
Post-Market Observational Study of the HARMONY® Evolution Implants and Instruments
An observational study of Total Hip Replacement, run by Symbios Orthopedie SA at 5 sites in France.
Trial summary
The purpose of this study is to evaluate the safety and performance of the HARMONY® Evolution implants in a series of operated subjects treated in THR. The objective is to demonstrate that the evaluated implants are compliant with the state of the art and the performance (PMA score > 15 points) \& safety claims (The… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Total Hip Replacement
- What is being tested?
- HARMONY EVOLUTION
- Type of treatment
- Medical device
- How many people
- 264 participants
- Where
- 5 sitesFrance
- Study dates
- 11 Oct 2023to 11 Mar 2035
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have provided consent for the collection of their data and met the protocol eligibility criteria will be enrolled into this study.
Who may be able to join
- Subjects of 18 years of age and older
- Each subject who is willing to give informed consent
- Clinically indicated for a Total Hip Replacement
- Women of childbearing age who are not pregnant and do not expect to become pregnant within 12 months. A pregnancy test should be performed for women of childbearing age
- Geographically stable and willing to return to the implanting site for all follow-up visits
Who cannot join
- Acute or chronic, local or systemic infection
- Muscular, neurological, psychological or vascular deficits
- Poor bone density and quality likely to affect implant stability (severe osteoporosis)
- Any concomitant condition likely to affect implant integration or function
- Allergy or hypersensitivity to any of the materials used
- Specific:
- The HARMONY® Evolution Standard stem size 8 shall not be implanted in subjects weighing more than 70 kg.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Polyclinique de Franche-Comté
Besançon
Antoine Serre, Dr., +33 (0)3 81 52 47 74, chirurgien.serre@gmail.com
- Recruiting
Clinique Belledonne
Grenoble, 38400
Christophe Besson, Dr., +33 (0)4 76 54 40 79, drbesson.christophe@gmail.com
- Recruiting
Clinique Juge
Marseille, 13008
Thomas Cucurrulo, Dr., +33 (0)4 91 22 02 03, tcucurulo@gmail.com
- Recruiting
Clinique Arago
Paris, 75014
Christophe Castelain, Dr., +33 (0)1 44 08 04 00, orthopediste@hotmail.com
- Recruiting
Médipôle Garonne
Toulouse, 31100
Nicolas Krantz, Dr., +33 (0)5 82 08 38 93, nicolas.krantz@gmail.com
About this study
The purpose of this study is to evaluate the safety and performance of the HARMONY® Evolution implants in a series of operated subjects treated in THR.
The objective is to demonstrate that the evaluated implants are compliant with the state of the art and the performance (PMA score > 15 points) \& safety claims (The expected acceptable revision rate (state of the art with a confidence interval of 95%) is 3% at 3 years, 5% at 5 years, 7% at 7 years and 10% at 10 years).
The endpoint of this study is to validate the expected performance of the HARMONY® Evolution implants with the PMA score at 10 years and to validate the safety claim with the expected acceptable revision rate at 10 years.
Read the detailed description
The study is prospective, multi-centric, observational, non-comparative, non-randomized and post market. About 264 subjects will be enrolled in this study to evaluate the safety and performance of the HARMONY® Evolution implants.
Patients will be included in the study during 12 months and followed-up during 10 years.
- Conditions
- Total Hip Replacement
- Being tested
- HARMONY EVOLUTION
- Keywords
- HARMONY, THR, Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HARMONY EVOLUTIONDevice
It is planned to include consecutive eligible subjects which will be treated with the HARMONY EVOLUTION devices.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety by means of measuring Adverse event recurrences
Proportion of patients requiring a revision.
Measured: 2 months, 1, 3, 5 and 10 years follow-up
Evaluate performance by means of clinical and quality of life scores
Score PMA > 15 points
Measured: 2 months, 1, 3, 5 and 10 years follow-up
Secondary outcomes (1)
Evaluate performance by means of surgeon satisfaction questionnaire
Evaluate the success of the surgical procedure and evaluate surgeon satisfaction regarding the implant components and the use of instruments with the criteria: very satisfied - satisfied - unsatisfied - very unsatisfied for each surgical step.
Measured: 2 months, 1, 3, 5 and 10 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start11 Oct 2023
- Primary completion11 Oct 2034 (estimated)
- Study completion11 Mar 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total 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
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Symbios Orthopedie SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe Castelain, Dr., Principal investigator, Clinique Arago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628336
- Sponsor's protocol ID
- CLIN-H-035
- Status last verified
- Oct 2024
- First submitted
- 2 May 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Observational Study of the HARMONY® Evolution Implants and Instruments
- ClinicalTrials.gov ID
- NCT06628336
- Acronym / sponsor ID
- CLIN-H-035
- Conditions
- Total Hip Replacement
- Keywords
- HARMONY, THR, Prosthesis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Symbios Orthopedie SAIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 11 Oct 2034 (estimated)
- Study completion
- 11 Mar 2035 (estimated)
- First posted
- 4 Oct 2024 (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.
The purpose of this study is to evaluate the safety and performance of the HARMONY® Evolution implants in a series of operated subjects treated in THR.
The objective is to demonstrate that the evaluated implants are compliant with the state of the art and the performance (PMA score > 15 points) \& safety claims (The expected acceptable revision rate (state of the art with a confidence interval of 95%) is 3% at 3 years, 5% at 5 years, 7% at 7 years and 10% at 10 years).
The endpoint of this study is to validate the expected performance of the HARMONY® Evolution implants with the PMA score at 10 years and to validate the safety claim with the expected acceptable revision rate at 10 years.
Detailed description
The study is prospective, multi-centric, observational, non-comparative, non-randomized and post market. About 264 subjects will be enrolled in this study to evaluate the safety and performance of the HARMONY® Evolution implants.
Patients will be included in the study during 12 months and followed-up during 10 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have provided consent for the collection of their data and met the protocol eligibility criteria will be enrolled into this study.
Key inclusion criteria (5 listed)
- Subjects of 18 years of age and older
- Each subject who is willing to give informed consent
- Clinically indicated for a Total Hip Replacement
- Women of childbearing age who are not pregnant and do not expect to become pregnant within 12 months. A pregnancy test should be performed for women of childbearing age
- Geographically stable and willing to return to the implanting site for all follow-up visits
Key exclusion criteria (7 listed)
- Acute or chronic, local or systemic infection
- Muscular, neurological, psychological or vascular deficits
- Poor bone density and quality likely to affect implant stability (severe osteoporosis)
- Any concomitant condition likely to affect implant integration or function
- Allergy or hypersensitivity to any of the materials used
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 |
|---|---|---|
| HARMONY EVOLUTIONIt is planned to include consecutive eligible subjects which will be treated with the HARMONY EVOLUTION devices. | Device | – |
Primary outcome
Evaluate safety by means of measuring Adverse event recurrences
Time frame: 2 months, 1, 3, 5 and 10 years follow-up
Proportion of patients requiring a revision.
Evaluate performance by means of clinical and quality of life scores
Time frame: 2 months, 1, 3, 5 and 10 years follow-up
Score PMA > 15 points
1 secondary outcome
Evaluate performance by means of surgeon satisfaction questionnaire
Time frame: 2 months, 1, 3, 5 and 10 years follow-up
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 4 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Christophe Castelain, Dr. principal investigator
Clinique Arago
5 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 Replacement, run by Symbios Orthopedie SA at 5 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 5 inclusion and 7 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 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 Bojana Gannevat (+41 24 424 26 26, bojana.gannevat@symbios.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate safety by means of measuring Adverse event recurrences (time frame: 2 months, 1, 3, 5 and 10 years follow-up). The study lists 2 primary outcomes in all. 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 4 Oct 2024.