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

NCT05227924 | Recruiting

• 1 other identifier: PMCF_SYMBOL_01
• Study Type: observational
• Target: 747
• Locations: 1 country
• Sites: 9

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.

Conditions

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

Outcome Measures

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.

  10 years post-operative

Secondary Outcomes (13)

• Survivorship of all individual SYMBOL orthopaedic components

  6 months, 18 months and 5 years post-operative

• Survivorship of the SYMBOL STEM VARA CEM orthopaedic implant.

  10 years post-operative

• Survivorship of the SYMBOL implants by component assembly (acetabular + femoral components)

  Through study completion, an average of 10 years

• Adverse Device Effects.

  Through study completion, an average of 10 years

• Radiographic assessment - Implant subsidence.

  6 months, 18 months, 5 and 10 years post-operative

Study Arms (1)

SYMBOL medical devices

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

Device: Total hip arthroplasty (primary or revision)

Interventions

Total hip arthroplasty (primary or revision) DEVICE

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

SYMBOL medical devices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient requiring total hip arthroplasty

You may qualify if:

• Patient age \> 18 years at implantation.
• Patient informed of his/her participation and willing to participate in the study.
• Patient able to read, write and understand French.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dedienne Sante S.A.S.: lead
• EVAMED: collaborator

Study Sites (9)

Hôpital Privé de la Châtaigneraie

Beaumont, 63110, France

RECRUITING

CH de Marmande - CHIC

Marmande, 47207, France

TERMINATED

Hôpital Privé du Grand Narbonne

Montredon-des-Corbières, 11100, France

RECRUITING

Polyclinique Grand Sud

Nîmes, 30932, France

RECRUITING

Clinique Mutualiste Catalane

Perpignan, 66140, France

RECRUITING

CH de Péronne

Péronne, 80200, France

RECRUITING

Clinique Mutualiste

Saint-Etienne, 83000, France

RECRUITING

Hôpital d'Instruction des Armées Saint-Anne

Toulon, 83000, France

RECRUITING

Hôpital Robert Schuman - UNEOS

Vantoux, 57070, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Femoral Neck Fractures; Femur Head Necrosis

Interventions

Arthroplasty, Replacement, Hip; Second-Look Surgery

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Osteonecrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Thomas Rousseau

  Clinique Mutualiste Catalane

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion Burland

CONTACT

+33 (0)4 66 28 06 85; reg.aff@dedienne-sante.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: February 8, 2022
• Study Start: September 21, 2021
• Primary Completion (Estimated): September 1, 2034
• Study Completion (Estimated): September 1, 2034
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

FR (9)