Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty

Dedienne Sante

Status

Enrolling

Conditions

Post-traumatic Osteoarthritis

Femoral Neck Fractures

Avascular Necrosis of the Femoral Head

Failure of Prosthetic Joint Implant

Hip Arthritis

Degenerative Hip Joint Disease

Treatments

Device: Total hip arthroplasty (primary or revision)

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05227924

PMCF_SYMBOL_01

Details and patient eligibility

About

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.

Enrollment

747 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.