Trial Outcomes & Findings for Allofit® IT With HXPE in Total Hip Arthroplasty (NCT NCT03672929)

Enrollment for this study was initiated in 2011 and was completed in 2017. Medizinische Universitat Wien, Universitatsklinik fur Orthopadie, Austria enrolled 41 patients, CHU de Nantes - Site Nord, France enrolled 36 patients, Kliniken Dr. Erler GmbH, Germany enrolled 50 patients, Orthopadie El Masry, Germany enrolled 40 patients and HUA Santiago enrolled 30 patients

Enrollment for this study was initiated in 2011 and was completed in 2017 with 197 patients enrolled in five participating study centers. One site which enrolled 30 patients is inactive since a long time an only has data up to 1-year Post-OP.

Unit of analysis: implants

The gender for 2 participants is not available

The objective of this study is implant survival at 10 years which is assessed by revision of the the study device. Survivorship at 10 years was defined as cases that had the implant still in place at 10 years.

Safety of the system will be assessed by monitoring the frequency and incidence of adverse events.

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

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 composed of two parts: a questionnaire and a visual analogue scale (VAS). 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. Higher scores mean a better outcome.

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 composed of two parts: a questionnaire and a visual analogue scale (VAS). The VAS is a vertical scale ranging from 100 ('The best health you can imagine') to 0 ('The worst health you can imagine') where the patient reports his/her current state of health. Higher scores mean a better outcome.

The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: \> 41; Good: 34 - 41; Fair: 27 - 33; Poor: \< 27. Higher scores mean a better outcome.

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). Higher scores mean a better outcome

X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence,heterotopic ossification, etc

X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence,heterotopic ossification, etc