The study is a multicenter, prospective, non-randomized, non-controlled consecutive cohort post-market clinical follow-up study.
The objectives of this study are to obtain survival and outcomes data on the Alloclassic® Variall® Cup in combination with the BIOLOX® delta Taper Liner and a BIOLOX® delta Femoral Head used in primary total hip arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Two sites are involved in this study, enrolling a total of 100 patients for the study. All subjects were required to participate in the Informed Consent Process.
Study Type
OBSERVATIONAL
Enrollment
100
Herz-Jesu Krankenhaus
Vienna, Austria
Orthopädisches Spital Speising GmbH
Vienna, Austria
Clinical Success Will be Based on the Harris Hip Scoring System
The Harris Hip Score (HHS) was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The score has a minimum of 0 points and a maximum of 100 points. Clinical success will be defined as a modified Harris Hip score of \> 80 that included a rating of 'mild', or 'no pain'; a failure will be defined as a modified Harris Hip score \< 80.
Time frame: 3 years
Percentage of Participants Who Survived According to the Survival Analysis With the Kaplan Meier (K-M) Estimate
Endpoint revision of any investigational device for any reason attributable to any investigational device
Time frame: 4 years
Oxford Hip Score
The purpose of the Oxford Hip Score (OHS) is to assess the outcome after total hip arthroplasty by measuring cases' perceptions in adjunction to surgery. The OHS assesses pain (6 items) and function (6 items) of the hip in relation to daily activities such as walking, dressing, sleeping, etc. The scoring is the following: 0-4 (worst to best) with overall scores ranging from 0-48 where 48 represents the best score
Time frame: 3 years
EQ-5D
The EQ-5D questionnaire comprises two parts. For the first part, respondents are asked to tick boxes to indicate the level of problem on each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). In total, there are three levels per dimension (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Responses are coded as single-digit numbers expressing the severity level selected in each dimension. The digits for the five dimensions are combined in a 5-digit code. The second part of the questionnaire is the EQ Visual Analogue Scale. This captures the respondent's overall assessment of their health from 0 (worst health imaginable) to 100 (best health imaginable). The results from both parts are indexed, weightened and pulled together. The final score lies between 1 for full health and 0 for death. Values less than 0 are possible considered to be worse than death.
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Time frame: 3 years