The study is designed as a prospective, non-interventional multicentre cohort study. The product under Investigation will be used in Routine clinical practice and according to the authorized Instructions for Use (IfU). Aim of this observational study is to collect clinical and radiological results of the CoreHip® endoprosthesis system in a Standard Patient Population and when used in Routine clinical practice.
The CoreHip® System has a range of different stem designs to address most of the indications and anatomical conditions met in Primary THA patients within one implant and Instrument System.
Study Type
OBSERVATIONAL
Enrollment
248
Replacement of the Hip Joint
Ortrhopädische Klinik Markgröningen
Markgröningen, Baden-Wurttemberg, Germany
Orthopädische Chirurgie München
München, Bavaria, Germany
MHH
Hanover, Lower Saxony, Germany
St. Josefs Krankenhaus Endoprothetik Zentrum
Salzkotten, Germany
Change of Hip Joint Function measured by Harris Hip Score over time (HHS)
The Harris Hip Score (HHS) assesses the results of hip surgery, evaluates various hip disabilities and methods of treatment in an adult population. The HHS is a clinician-based outcome measure. The domains covered are pain (pain severity and its effect on activities and need for pain medication), function (daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance)), absence of deformity, and range of Motion (hip flexion, adduction, internal rotation, and extremity length discrepancy). There are 10 items. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).
Time frame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative
Restoration of preoperative leg length
Comparison of preoperative and postoperative leg length
Time frame: preoperative and 3 months postoperative
Restoration of preoperative offset
Comparison of preoperative and postoperative Offset angle of the femoral neck
Time frame: preoperative and 3 months postoperative
Change of Oxford Hip Score (OHS) over time
A patient-reported outcome instrument which contains 12 questions on activities of daily living that assess function and residual pain in patients undergoing total hip replacement (THR) surgery. The score has a maximum of 48 points (best possible outcome), each question has five answers, ranging from 4 Points (best possible) to 0 Points (worst possible).
Time frame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative
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Spital Brig
Brig, Switzerland
Luzerner Kantonsspital Sursee
Sursee, Switzerland
Change of Quality of Life (EQ-5D-5L) over time
EuroQol five-dimension scale. A standardised instrument created by the EuroQol Group as a measure of health outcome. EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which can take one of five Levels reflecting severity (no problems, slight problems, moderate problems, severe problems and extreme Problems). Each answer results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time frame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative
Change of Radiological results: implant position
Changes in implant Position throughout the follow-up period
Time frame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative
Development of Radiological results: radiolucent lines
Development of radiolucent lines ("Gruen" zones) in AP and lateral x-rays throughout the follow-up period
Time frame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative
Adverse Events
documentation of all product related adverse Events occuring with the Hip Prosthesis throughout the follow-up period
Time frame: up to five years
Survival Rate of the Hip Prosthesis
Survival Analysis of stems in-situ throughout the follow-up period
Time frame: up to five years