Degenerative Hip Joint DiseaseNCT05227924
Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
An observational study of Degenerative Hip Joint Disease and Post-traumatic Osteoarthritis, run by Dedienne Sante S.A.S. at 9 sites in France.
Trial summary
The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices. The study will evaluate the outcome of Total Hip Arthroplasty using medical devices from SYMBOL range over a period of 10 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis, Hip Arthritis
- What is being tested?
- Total hip arthroplasty (primary or revision)
- Type of treatment
- Medical device
- How many people
- 747 participants
- Where
- 9 sitesFrance
- Study dates
- 21 Sep 2021to Sep 2034
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient requiring total hip arthroplasty
Who may be able to join
- Patient age > 18 years at implantation.
- Patient who will undergo, during the study's period of inclusion, a total hip arthroplasty (primary or revision) with at least one SYMBOL medical device (DEDIENNE Santé).
- Patient informed of his/her participation and willing to participate in the study.
- Patient able to read, write and understand French.
Who cannot join
- Patient deprived of freedom, under guardianship/curatorship or placed under judicial protection
- Patient unable to follow study procedures.
- Patient who has already been included in the study for a total hip arthroplasty (primary or revision) with at least one SYMBOL medical device.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 8 recruiting
- Recruiting
Hôpital Privé de la Châtaigneraie
Beaumont, 63110
- Terminated
CH de Marmande - CHIC
Marmande, 47207
- Recruiting
Hôpital Privé du Grand Narbonne
Montredon-des-Corbières, 11100
- Recruiting
Polyclinique Grand Sud
Nîmes, 30932
- Recruiting
CH de Péronne
Péronne, 80200
- Recruiting
Clinique Mutualiste Catalane
Perpignan, 66140
- Recruiting
Clinique Mutualiste
Saint-Etienne, 83000
- Recruiting
Hôpital d'Instruction des Armées Saint-Anne
Toulon, 83000
- Recruiting
Hôpital Robert Schuman - UNEOS
Vantoux, 57070
About this study
The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices. The study will evaluate the outcome of Total Hip Arthroplasty using medical devices from SYMBOL range over a period of 10 years.
- Conditions
- Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis, Hip Arthritis, Femoral Neck Fractures, Avascular Necrosis of the Femoral Head, Failure of Prosthetic Joint Implant
- Being tested
- Total hip arthroplasty (primary or revision)
- Medical subject headings
- Osteoarthritis, Hip, Femoral Neck Fractures, Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplasty (primary or revision)Device
Total hip arthroplasty with at least one medical device from the SYMBOL range
| Study group | Role | What they receive |
|---|---|---|
| SYMBOL medical devices | Patients undergoing total hip arthroplasty with at least one medical device from the SYMBOL range Receives: Device: Total hip arthroplasty (primary or revision) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship of 13 individual SYMBOL orthopaedic components
The survival rate of an orthopaedic implant will be calculated on the basis of the first occurrence of implant revision from any cause.
Measured: 10 years post-operative
Secondary outcomes (13)
Survivorship of all individual SYMBOL orthopaedic components
The survival rate of an orthopaedic implant will be calculated on the basis of the first occurrence of implant revision from any cause.
Measured: 6 months, 18 months and 5 years post-operative
Survivorship of the SYMBOL STEM VARA CEM orthopaedic implant.
The survival rate of an orthopaedic implant will be calculated on the basis of the first occurrence of implant revision from any cause.
Measured: 10 years post-operative
Survivorship of the SYMBOL implants by component assembly (acetabular + femoral components)
The survival rate of a combinaison of implant (acetabular + femoral component) will be calculated on the basis of the first occurrence of implant revision from any cause.
Measured: Through study completion, an average of 10 years
Adverse Device Effects.
All adverse device effects occurring from the time of subject enrollment until study termination or study completion including intra-operative adverse events.
Note: This outcome will also be used for subgroup analyses by component association.
Measured: Through study completion, an average of 10 years
Radiographic assessment - Implant subsidence.
Stem subsidence will be classified based on the following:
- Stem subsidence < 3mm
- Stem subsidence between 3 and 5mm
- Stem subsidence > 5mm
Note: This outcome will also be used for subgroup analyses by component association.
Measured: 6 months, 18 months, 5 and 10 years post-operative
Radiographic assessment - Osteolysis (granuloma).
Assessment will consider:
- Presence or absence of osteolysis. If osteolysis is present, impacted areas will be determined according to DeLee and Charnley or Gruen classification.
Note: This outcome will also be used for subgroup analyses by component association.
Measured: 6 months, 18 months, 5 and 10 years post-operative
Radiographic assessment - Radiolucent lines.
Assessment will consider:
- Presence or absence of radiolucent lines.
If radiolucent line is present:
- Impacted areas will be determined according to DeLee and Charnley or Gruen classification.
- Type of radiolucent lines will be classified based on the following : < 2mm - regular or > 2mm - irregular.
Note: This outcome will also be used for subgroup analyses by component association.
Measured: 6 months, 18 months, 5 and 10 years post-operative
Radiographic assessment - Eterotopic ossifications.
Assessment will consider:
- Presence or absence of eterotopic ossifications. If eterotopic ossification, grade will be specified.
This outcome will also be measured for subgroup analyses by component association.
Measured: 6 months, 18 months, 5 and 10 years post-operative
Harris Hip Score (or modified Harris Hip Score) at each visit.
The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain, function, functional activities, absence of deformity, and hip range of motion.
Note: This outcome will also be used for subgroup analyses by component association.
Measured: Pre-operative, 6 months, 18 months, 5 and 10 years post-operative
Pain intensity (Numeric Rating Scale)
Numeric Rating scale for pain intensity assessment:
- Minimum value: 0 (=no pain)
- Maximum value: 10 (= worst possible pain). (Higher scores mean worst outcome).
Note: This outcome will also be used for subgroup analyses by component association.
Measured: Pre-operative, 6 months, 18 months, 5 and 10 years post-operative
EQ-5D-5L score
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale. The descriptive system is used to describe the subject's health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
The visual analogue scale records the subject's self-rated health on a vertical visual analogue scale.
Note: This outcome will also be used for subgroup analyses by component association.
Measured: Pre-operative, 18 months, 5 and 10 years post-operative
Global patient satisfaction
Ordinal scale for global patient satisfaction assessment:
- Possible values are: not satisfied/quite satisfied/satisfied/very satisfied ("Very satisfied" is the best possible outcome).
Measured: 18 months post-operative
Hip joint patient satisfaction (Numeric Rating Scale)
Numeric rating scale : Percentage Scale for Hip Joint Patient Satisfaction Assessment.
Range of values: from 0 to 100. (100 is the best possible outcome and is equivalent to a normal hip).
Note: This outcome will also be used for subgroup analyses by component association.
Measured: 5 years and10 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start21 Sep 2021
- Primary completionSep 2034 (estimated)
- Study completionSep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Hip Joint DiseaseStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 747 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dedienne Sante S.A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
- Investigators
- Thomas Rousseau, Principal investigator, Clinique Mutualiste Catalane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227924
- Sponsor's protocol ID
- PMCF_SYMBOL_01
- Status last verified
- Aug 2024
- First submitted
- 2 Dec 2021
- Last updated
- 27 Aug 2024
- 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 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05227924
- Acronym / sponsor ID
- PMCF_SYMBOL_01
- Conditions
- Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis, Hip Arthritis, Femoral Neck Fractures, Avascular Necrosis of the Femoral Head, Failure of Prosthetic Joint Implant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 747 participants (estimated)
- Lead sponsor
- Dedienne Sante S.A.S.Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- Sep 2034 (estimated)
- Study completion
- Sep 2034 (estimated)
- First posted
- 8 Feb 2022 (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 post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices. The study will evaluate the outcome of Total Hip Arthroplasty using medical devices from SYMBOL range over a period of 10 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SYMBOL medical devices | – | Device: Total hip arthroplasty (primary or revision)Patients undergoing total hip arthroplasty with at least one medical device from the SYMBOL range |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient requiring total hip arthroplasty
Key inclusion criteria (4 listed)
- Patient age > 18 years at implantation.
- Patient who will undergo, during the study's period of inclusion, a total hip arthroplasty (primary or revision) with at least one SYMBOL medical device (DEDIENNE Santé).
- Patient informed of his/her participation and willing to participate in the study.
- Patient able to read, write and understand French.
Key exclusion criteria (3 listed)
- Patient deprived of freedom, under guardianship/curatorship or placed under judicial protection
- Patient unable to follow study procedures.
- Patient who has already been included in the study for a total hip arthroplasty (primary or revision) with at least one SYMBOL medical device.
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 (primary or revision)Total hip arthroplasty with at least one medical device from the SYMBOL range | Device | SYMBOL medical devices |
Primary outcome
Survivorship of 13 individual SYMBOL orthopaedic components
Time frame: 10 years post-operative
The survival rate of an orthopaedic implant will be calculated on the basis of the first occurrence of implant revision from any cause.
13 secondary outcomes
Survivorship of all individual SYMBOL orthopaedic components
Time frame: 6 months, 18 months and 5 years post-operative
Survivorship of the SYMBOL STEM VARA CEM orthopaedic implant.
Time frame: 10 years post-operative
Survivorship of the SYMBOL implants by component assembly (acetabular + femoral components)
Time frame: Through study completion, an average of 10 years
Adverse Device Effects.
Time frame: Through study completion, an average of 10 years
Radiographic assessment - Implant subsidence.
Time frame: 6 months, 18 months, 5 and 10 years post-operative
Radiographic assessment - Osteolysis (granuloma).
Time frame: 6 months, 18 months, 5 and 10 years post-operative
Radiographic assessment - Radiolucent lines.
Time frame: 6 months, 18 months, 5 and 10 years post-operative
Radiographic assessment - Eterotopic ossifications.
Time frame: 6 months, 18 months, 5 and 10 years post-operative
Harris Hip Score (or modified Harris Hip Score) at each visit.
Time frame: Pre-operative, 6 months, 18 months, 5 and 10 years post-operative
Pain intensity (Numeric Rating Scale)
Time frame: Pre-operative, 6 months, 18 months, 5 and 10 years post-operative
EQ-5D-5L score
Time frame: Pre-operative, 18 months, 5 and 10 years post-operative
Global patient satisfaction
Time frame: 18 months post-operative
Hip joint patient satisfaction (Numeric Rating Scale)
Time frame: 5 years and10 years post-operative
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 27 Aug 2024.
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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.
Thomas Rousseau principal investigator
Clinique Mutualiste Catalane
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Hip Joint Disease and Post-traumatic Osteoarthritis, run by Dedienne Sante S.A.S. at 9 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 4 inclusion and 3 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 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 Marion Burland (+33 (0)4 66 28 06 85, reg.aff@dedienne-sante.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivorship of 13 individual SYMBOL orthopaedic components (time frame: 10 years post-operative). 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 27 Aug 2024.