This is a multi-center, prospective, non-controlled post market surveillance study. The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty.
The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility and survivorship, and to confirm the safety and performance of the Allofit IT Ceramic Bearing System. A total of 200 patients are planned to be enrolled in this study which will last 12 years (2 year enrollment plus 10 years follow-up) with the follow-up visits at 6 months, 1, 2, 3, 5, 7, and 10 years post-operatively.
Study Type
OBSERVATIONAL
Enrollment
185
Sana Kliniken Sommerfeld
Kremmen, Germany
Universitätsklinikum Magdeburg A.ö.R.
Magdeburg, Germany
LVR-Klinik für Orthopädie
Viersen, Germany
Skåne University Hospital
Lund, Sweden
Survivorship
The objective of this study is implant survival at 10 years which is assessed by revision of the the study device calculated using the Kaplan-Meier Survival Estimation. The survivorship with Kaplan-Meier (K-M) was calculated at 10 year for endpoint revision of any component.
Time frame: 10 years post-surgery
Safety of the Implant
Will be evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) b) Efficacy:
Time frame: Up to 10 years postoperative
Harris Hip Score
The Harris Hip Score (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \< 70
Time frame: pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
EQ-5D
The EQ-5D-3L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life. The questionnaire includes five dimensions referring to mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each question can be answered in three ways/levels indicating no problems, some problems, and extreme problems. In the derived EQ-5D-3L score, the highest score is 1 and the lowest score is -0.594; negative numbers correspond to a self-assessed health state worse than being dead.
Time frame: pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
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SF-12 Physical and Mental Functional Scores
The SF-12 is a multipurpose short-form (SF) generic measure of health status. It consists of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). Scores ranges from 0 to 100, with higher scores indicating better physical and mental health functioning and lower scores indicating worse physical and mental health functioning.
Time frame: pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
UCLA Activity Score
The case administered University of California at Los Angeles (UCLA) score allows assessment of the case's activity level at each time point with scores from 1 (Wholly inactive: dependent on others; cannot leave residence) to 10 (Regularly participates in impact sports)
Time frame: pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Radiographic Evaluations
Radiographic evaluation was done to assess (radiolucency, osteolysis, subsidence, cup migration, change in cup angle and change in femoral shaft angle) of study subjects who received the Allofit IT Acetabular System
Time frame: 10 Years post-surgery