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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

747 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-21

Study Completion Date

2034-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Degenerative Hip Joint Disease Post-traumatic Osteoarthritis Hip Arthritis Femoral Neck Fractures Avascular Necrosis of the Femoral Head Failure of Prosthetic Joint Implant

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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SYMBOL medical devices

Patients undergoing total hip arthroplasty with at least one medical device from the SYMBOL range

Total hip arthroplasty (primary or revision)

Intervention Type DEVICE

Total hip arthroplasty with at least one medical device from the SYMBOL range

Interventions

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Total hip arthroplasty (primary or revision)

Total hip arthroplasty with at least one medical device from the SYMBOL range

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No