CoreHip - Post Market Clinical Follow-Up Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective, Non-Interventional, Multicenter, Post-Market Clinical Follow-up Study CoreHip®

Conditions
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Degenerative Osteoarthritis, Rheumatic Arthritis, Fractures, Hip, Necrosis, Femur Head

Intervention / Treatment
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* Device: CoreHip Total Hip Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age ≥ 18 years Indication for THA with a CoreHip® stem Written informed consent Exclusion Criteria: Pregnancy Patient age < 18 years Patient not able to regularly participate at the follow-up examinations

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CoreHip<br>Clinical and Radiological Data of 300 patients of a Standard Patient Population, who are treated with CoreHip Total Hip Arthroplasty for Indications according to the Instructions for Use (IfU) with a five year follow Up | Device: CoreHip Total Hip Arthroplasty<br>* Replacement of the Hip Joint<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration of preoperative leg length | Comparison of preoperative and postoperative leg length | preoperative and 3 months postoperative | 
| Restoration of preoperative offset | Comparison of preoperative and postoperative Offset angle of the femoral neck | 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). | Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative | 
| 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. | 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 | 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 | 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 | up to five years | 
| Survival Rate of the Hip Prosthesis | Survival Analysis of stems in-situ throughout the follow-up period | up to five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip Arthroplasty, Hip Prosthesis