This study is aimed to provide a clinical and radiographic evaluation of 120 suitable subjects who underwent a total hip arthroplasty with MINIMA stem coupled with Delta TT or Delta ST-C cup.
This is a post-market, interventional, prospective, randomized, not comparative, open label study designed to reflect real life clinical practice as closely as possible.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
120
Patients are allocated in 2 different group (one with ST-C Cup and another one with TT Cup)
The Orthopedic Clinic University Hospital Martin
Martin, Slovakia
Harris Hip Score (HHS)
Functional changes in Harris Hip Score (HHS) from preoperative (baseline) to 3 years after surgery. The Harris Hip Score is composed of ten items covering foru domains: pain, fuction, absence of deformity and range of motion. The maximum score is 100 points. Pain domain contributes 44 points, function 47, Range of Motion 5 and absence of deformity 4 points. Results can be interpreted as follows: less than 60 points corresponds to a failed result, from 60 to 69 to a poor result, from 70 to 79 points to a fair outcome, from 80 to 90 to a good result ad from 90 to 100 to an excellent outcome. Overall, the outcome is considered satisfactory for values over 80 points.
Time frame: Pre-operative, 3 months, 6 months, 1 year and 3 years
Harris Hip Score (HHS)
Functional changes in Harris Hip Score (HHS) from preoperative (baseline) to 5 years after surgery. The Harris Hip Score is composed of ten items covering foru domains: pain, fuction, absence of deformity and range of motion. The maximum score is 100 points. Pain domain contributes 44 points, function 47, Range of Motion 5 and absence of deformity 4 points. Results can be interpreted as follows: less than 60 points corresponds to a failed result, from 60 to 69 to a poor result, from 70 to 79 points to a fair outcome, from 80 to 90 to a good result ad from 90 to 100 to an excellent outcome. Overall, the outcome is considered satisfactory for values over 80 points.
Time frame: 5 years
Implant stability
Radiographic implant evaluation and stability assessment at 6 months, 1 year, 3 years, 5 years after surgery
Time frame: 6 months, 1 year, 3 years, 5 years after surgery
Oxford Hip Score (OHS)
Functional changes in Oxford Hip Score (OHS) from preoperative (baseline) to 5 years after surgery. The Oxford Hip Score is composed of two domains (pain and function) with six items or questions in each that are scored as follows: each question can be scored from 0 to 4, with 4 being the best outcome, producing overall scores running from 0 to 48, with 48 being the best outcome. The calculation of the total score is based on the above-mentioned scoring system, with a score reported as excellent for more than 41 points, good from 34 to 41, fair from 27 to 33 and poor for less than 27 points.
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Time frame: Pre-operative, 3 months, 6 months, 1 year, 3 years, and 5 years
Forgotten Joint Score (FJS)
Changes in Forgotten Joint Score (FJS) from 3 months (baseline) to 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery. The Forgotten Joint Score is a 12 item questionnaire that integrates variables such as pain, stiffness, function on activities of daily living, ptients' expectations and activity levels and finally psychosocial factors. It consist of 12 questions scored using a 5-point Likert response format (never-almost never-seldom-sometimes-mostly) with raw scores transformed onto a 0-100 point scale. High scores indicate good outcome, that is, a high degree of "forgetting" the joint.
Time frame: 3 months (baseline) to 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery
Survival Rate
Survival rate expressed with Kaplan-Meier estimator at 5 years after surgery
Time frame: 5 years
Safety assessment
Incidence, type, and severity of all the Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) occurred at each follow-up.
Time frame: Intra operative, 3 months, 6 months, 1 year, 3 years, 5 years