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

ConditionsDegenerative Hip Joint DiseasePost-traumatic OsteoarthritisHip ArthritisFemoral Neck FracturesAvascular Necrosis of the Femoral HeadFailure of Prosthetic Joint Implant
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDedienne Sante S.A.S.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

Patient requiring total hip arthroplasty

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Total hip arthroplasty (primary or revision)

    Device

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

Treatment groups

747 Participants
are divided into 1 treatment group
Group A: SYMBOL medical devices1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
10 years post-operative

Secondary outcomes

1

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.

Time frame
6 months, 18 months and 5 years post-operative
2

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.

Time frame
10 years post-operative
3

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.

Time frame
Through study completion, an average of 10 years
4

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.

Time frame
Through study completion, an average of 10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dedienne Sante S.A.S.

Lead sponsor

EVAMED

Collaborator

Source ClinicalTrials.gov
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