This is a single-center retrospective observational cohort study of consecutively operated patients who underwent total hip arthroplasty (THA) with a SYMBOL CUP DMR HA or a SYMBOL CUP DM CEM hemispherical dual mobility acetabular implant. The purpose of this study is to estimate the safety and efficacy of those two implants at two-year follow-up.
Description according to PICOS (Patient, Intervention, Comparator, Outcomes, Study design) framework: Patients: \- Adult men and women requiring a total hip arthroplasty Intervention: \- THA with SYMBOL CUP DMR HA or SYMBOL CUP DM CEM hemispherical dual mobility acetabular implants. 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 (mHHS) 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 followups. Study design: * single-center retrospective observational cohort study of consecutively operated patients who underwent total hip arthroplasty 2 years prior to study start. * Prospective 2-year follow-up letter and phone questionnaire.
Study Type
OBSERVATIONAL
Enrollment
20
Hôpital Privé Medipole de Savoie
Challes-les-Eaux, France
Implant Survival: Acetabular Cup Survival at 2-year Follow-up
This is a the ratio of the number of patient joints surviving with the acetabular prosthesis in position at a given follow-up time (numerator) over the initial number of those joints from the date they received the acetabular prosthesis (denominator). The cumulative ratio is recalculated at each event using the Kaplan-Meier method from the date of each joint 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 acetabular prosthesis in place. The longest duration between the index operation and the final assessment is 2 years.
Time frame: 2 years as of index operation
Number of Patients With One or Several Post-operative Adverse Events and Count of Each Serious Adverse Event and Aggregate Count of Adverse Events
All serious post-operative adverse events are taken into account including implant dislocation, infections, revision surgery.
Time frame: 2 years as of index operation
Harris Hip Score (HHS) at Baseline and 1-year Follow-up
Harris Hip Score (HHS) is measured at each assessment in each patient. HHS is a physician-completed instrument that consists of subscales for pain severity (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 0-4 points), and range of motion (2 items, 0-5 points). Scores range from 0 (worse disability) to 100 (less disability). The mean and confidence interval of the score is measured at each assessment as well as for the within-patient difference between assessments
Time frame: 1 year as of index operation
The Modified Harris Hip Score (Modified HHS) at Baseline, 1-year and 2-year Follow-up
The modified Harris Hip Score (modified HHS) is the sum of pain subscore and functional subscore of the Harris Hip Score. It consists of subscales for pain severity (1 item, 0-44 points), function (7 items, 0-47 points). Scores range from 0 (worse disability) to 91 (less disability)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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 2 years as of index operation