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NCT Number: NCT05227924

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

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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Key information

Conditions

Degenerative Hip Joint Disease Arthritis Avascular Necrosis of the Femoral Head Bone Diseases Failure of Prosthetic Joint Implant Femoral Fractures Femoral Neck Fractures Femur Head Necrosis Fractures, Bone Hip Arthritis Hip Fractures Hip Injuries Joint Diseases Leg Injuries Musculoskeletal Diseases Necrosis Osteoarthritis Osteoarthritis, Hip Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Post-traumatic Osteoarthritis Rheumatic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Privé de la Châtaigneraie, Beaumont, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total hip arthroplasty (primary or revision)

Device

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

Primary outcomes

  1. Survivorship of 13 individual SYMBOL orthopaedic components

    Time frame: 10 years post-operative

    The survival rate of an orthopaedic implant will be calculated on the basis of the first occurrence of implant revision from any cause.

Secondary outcomes

  1. Survivorship of all individual SYMBOL orthopaedic components

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

    The survival rate of an orthopaedic implant will be calculated on the basis of the first occurrence of implant revision from any cause.

  2. Survivorship of the SYMBOL STEM VARA CEM orthopaedic implant.

    Time frame: 10 years post-operative

    The survival rate of an orthopaedic implant will be calculated on the basis of the first occurrence of implant revision from any cause.

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

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

    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.

  4. Adverse Device Effects.

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

    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.

  5. Radiographic assessment - Implant subsidence.

    Time frame: 6 months, 18 months, 5 and 10 years post-operative

    Stem subsidence will be classified based on the following:

    • Stem subsidence < 3mm
    • Stem subsidence between 3 and 5mm
    • Stem subsidence > 5mm

    Note: This outcome will also be used for subgroup analyses by component association.

  6. Radiographic assessment - Osteolysis (granuloma).

    Time frame: 6 months, 18 months, 5 and 10 years post-operative

    Assessment will consider:

    • Presence or absence of osteolysis. If osteolysis is present, impacted areas will be determined according to DeLee and Charnley or Gruen classification.

    Note: This outcome will also be used for subgroup analyses by component association.

  7. Radiographic assessment - Radiolucent lines.

    Time frame: 6 months, 18 months, 5 and 10 years post-operative

    Assessment will consider:

    • Presence or absence of radiolucent lines.

    If radiolucent line is present:

    • Impacted areas will be determined according to DeLee and Charnley or Gruen classification.
    • Type of radiolucent lines will be classified based on the following : < 2mm - regular or > 2mm - irregular.

    Note: This outcome will also be used for subgroup analyses by component association.

  8. Radiographic assessment - Eterotopic ossifications.

    Time frame: 6 months, 18 months, 5 and 10 years post-operative

    Assessment will consider:

    • Presence or absence of eterotopic ossifications. If eterotopic ossification, grade will be specified.

    This outcome will also be measured for subgroup analyses by component association.

  9. Harris Hip Score (or modified Harris Hip Score) at each visit.

    Time frame: Pre-operative, 6 months, 18 months, 5 and 10 years post-operative

    The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain, function, functional activities, absence of deformity, and hip range of motion.

    Note: This outcome will also be used for subgroup analyses by component association.

  10. Pain intensity (Numeric Rating Scale)

    Time frame: Pre-operative, 6 months, 18 months, 5 and 10 years post-operative

    Numeric Rating scale for pain intensity assessment:

    • Minimum value: 0 (=no pain)
    • Maximum value: 10 (= worst possible pain). (Higher scores mean worst outcome).

    Note: This outcome will also be used for subgroup analyses by component association.

  11. EQ-5D-5L score

    Time frame: Pre-operative, 18 months, 5 and 10 years post-operative

    The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale. The descriptive system is used to describe the subject's health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

    The visual analogue scale records the subject's self-rated health on a vertical visual analogue scale.

    Note: This outcome will also be used for subgroup analyses by component association.

  12. Global patient satisfaction

    Time frame: 18 months post-operative

    Ordinal scale for global patient satisfaction assessment:

    • Possible values are: not satisfied/quite satisfied/satisfied/very satisfied ("Very satisfied" is the best possible outcome).

  13. Hip joint patient satisfaction (Numeric Rating Scale)

    Time frame: 5 years and10 years post-operative

    Numeric rating scale : Percentage Scale for Hip Joint Patient Satisfaction Assessment.

    Range of values: from 0 to 100. (100 is the best possible outcome and is equivalent to a normal hip).

    Note: This outcome will also be used for subgroup analyses by component association.

Study contacts

Contact information is provided by the study sponsor or research team.

Marion Burland

CONTACT

[email protected]

+33 (0)4 66 28 06 85

Sponsors and collaborators

Lead sponsor

Dedienne Sante S.A.S.

Industry

Collaborators

  • EVAMED

Registry information

Important dates

Study start
2021
Primary completion
2034
Study completion
2034
First posted
Feb 8, 2022
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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