Clinical trial NCT05227924: Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
Official title: Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Degenerative Hip Joint Disease
Post-traumatic Osteoarthritis
Hip Arthritis
Femoral Neck Fractures
Avascular Necrosis of the Femoral Head
Failure of Prosthetic Joint Implant
Lead sponsor: Dedienne Sante S.A.S.
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
First posted: 2022-02-08
Enrollment: 747
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient requiring total hip arthroplasty

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Survivorship of 13 individual SYMBOL orthopaedic components
timeFrame: 10 years post-operative
Secondary outcomes:
measure: Survivorship of all individual SYMBOL orthopaedic components
timeFrame: 6 months, 18 months and 5 years post-operative
measure: Survivorship of the SYMBOL STEM VARA CEM orthopaedic implant.
timeFrame: 10 years post-operative
measure: Survivorship of the SYMBOL implants by component assembly (acetabular + femoral components)
timeFrame: Through study completion, an average of 10 years
measure: Adverse Device Effects.
timeFrame: Through study completion, an average of 10 years
measure: Radiographic assessment - Implant subsidence.
timeFrame: 6 months, 18 months, 5 and 10 years post-operative
measure: Radiographic assessment - Osteolysis (granuloma).
timeFrame: 6 months, 18 months, 5 and 10 years post-operative
measure: Radiographic assessment - Radiolucent lines.
timeFrame: 6 months, 18 months, 5 and 10 years post-operative
measure: Radiographic assessment - Eterotopic ossifications.
timeFrame: 6 months, 18 months, 5 and 10 years post-operative
measure: Harris Hip Score (or modified Harris Hip Score) at each visit.
timeFrame: Pre-operative, 6 months, 18 months, 5 and 10 years post-operative
measure: Pain intensity (Numeric Rating Scale)
timeFrame: Pre-operative, 6 months, 18 months, 5 and 10 years post-operative
measure: EQ-5D-5L score
timeFrame: Pre-operative, 18 months, 5 and 10 years post-operative
measure: Global patient satisfaction
timeFrame: 18 months post-operative
measure: Hip joint patient satisfaction (Numeric Rating Scale)
timeFrame: 5 years and10 years post-operative
Other outcomes:
Locations:
city: Beaumont
country: France
facility: Hôpital Privé de la Châtaigneraie
city: Marmande
country: France
facility: CH de Marmande - CHIC
city: Montredon-des-Corbières
country: France
facility: Hôpital Privé du Grand Narbonne
city: Nîmes
country: France
facility: Polyclinique Grand Sud
city: Perpignan
country: France
facility: Clinique Mutualiste Catalane
city: Péronne
country: France
facility: CH de Péronne
city: Saint-Étienne
country: France
facility: Clinique Mutualiste
city: Toulon
country: France
facility: Hôpital d'Instruction des Armées Saint-Anne
city: Vantoux
country: France
facility: Hôpital Robert Schuman - UNEOS
Study officials:
affiliation: Clinique Mutualiste Catalane
name: Thomas Rousseau
role: PRINCIPAL_INVESTIGATOR
References: