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Completed

NCT Number: NCT04209374

Retrospective Observational Cohort Study of SYMBOL CUP DM 1

This is a single-center retrospective observational cohort study of consecutively operated patients who underwent primary total hip arthroplasty with a SYMBOL CUP DM HA hemispherical dual mobility acetabular implant. The purpose of this study is to estimate the safety and efficacy of that implant at two-year follow-up.

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Key information

Conditions

Primary Total Hip Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lyon Ortho Clinic - Clinique de la Sauvegarde

Lyon, 69009, France

About this study

Description according to PICOS framework:

Patients:

  • Adult men and women requiring a primary total hip arthroplasty

Intervention:

  • Primary THA with SYMBOL CUP DM HA hemispherical dual mobility acetabular implant.

Comparator: None

Outcomes:

  • Safety 1: Implant survival over 2-year follow-up.
  • Safety 2: All adverse events, with focus on implant dislocation, infections, revision surgery
  • Efficacy 1: Harris Hip Score (HHS) at baseline and 1-year follow-up.
  • Efficacy 2: Modified HHS consisting of pain + functional subscores at baseline, 1-year and 2-year follow-ups.
  • Efficacy 2: Devane score at baseline, 1-year and 2-year follow-ups.
  • Efficacy 3: Charnley classification at baseline, 1-year and 2-year follow-ups.

Study design:

  • single-center retrospective observational cohort study of consecutively operated patients who underwent primary total hip arthroplasty 2 years prior to study start.
  • Prospective 2-year follow-up letter and phone questionnaire.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients with total hip implant using hemispheric dual-mobility SYMBOL CUP DM HA
  • Operation performed by the primary investigator
  • Delay between index operation and March 1 2018 has reached 2 years

Exclusion criteria

  • patient refusal to participate in the study
  • minors (age < 18 years)
  • patients under guardianship

Treatment and study plan

THA with SYMBOL CUP DM HA

Device

Primary outcomes

  1. Implant survival: Ratio of the number of participants alive with the complete index hip prosthesis in position at 2-year follow-up, over their initial numberprosthesis in position at 2-year follow-up, over their initial number.

    Time frame: 2 years as of index operation

    This is the ratio of the number of participants who are alive with the complete index hip prosthesis in position at a given follow-up time (numerator) over the initial number of those participants from the date they received the index hip prosthesis (denominator). The cumulative ratio is recalculated at each event using the Kaplan-Meier method from the date of each participant index operation through the date of each participant's death or prosthetic removal surgery or loss-to-follow-up or last assessment alive with the hip prosthesis in place. The longest duration between the index operation and the final assessment is 2 years.

Secondary outcomes

  1. Number of patients with one or several post-operative adverse events and count of each Serious adverse event and aggregate count of adverse events

    Time frame: 2 years as of index operation

    All serious post-operative adverse events are taken into account including implant dislocation, infections, revision surgery

  2. Harris Hip Score (HHS) at baseline and 1-year follow-up

    Time frame: 1 year as of index operation

    The score is measured at each assessment in each patient. The mean and confidence interval of the score is measured at each assessment as well as for the within-patient difference between assessments

  3. The modified Harris Hip Score (modified HHS) at baseline, 1-year and 2-year follow-up

    Time frame: 2 years as of index operation

    The modified Harris Hip Score (modified HHS) is the sum of pain subscore and functional subscore of the Harris Hip Score. The score is measured at each assessment in each patient. The mean and confidence interval of the score is measured at each assessment as well as for the within-patient difference between assessments

  4. Devane classification at baseline, 1-year and 2-year follow-up.

    Time frame: 2 years as of index operation

    The class is measured at each assessment in each patient. The mean and confidence interval of the score is measured at each assessment as well as for the within-patient difference between assessments

  5. Charnley classification at baseline, 1-year and 2-year follow-up.

    Time frame: 2 years as of index operation

    The class is measured at each assessment in each patient. The mean and confidence interval of the score is measured at each assessment as well as for the within-patient difference between assessments

Sponsors and collaborators

Lead sponsor

Dedienne Sante S.A.S.

Industry

Registry information

Official study title

Etude de Cohorte Observationnelle Rétrospective SYMBOL CUP 1

Acronym: SYMCOR-1

Important dates

Study start
2014
Primary completion
2015
Study completion
2018
First posted
Dec 24, 2019
Registry last updated
Dec 30, 2019

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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