CoreHip - Post Market Clinical Follow-Up Study
- Conditions
- Rheumatic ArthritisDegenerative OsteoarthritisNecrosis, Femur HeadFractures, Hip
- Interventions
- Device: CoreHip Total Hip Arthroplasty
- Registration Number
- NCT03685110
- Lead Sponsor
- Aesculap AG
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 248
- Patient age ≥ 18 years
- Indication for THA with a CoreHip® stem
- Written informed consent
- Pregnancy
- Patient age < 18 years
- Patient not able to regularly participate at the follow-up examinations
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CoreHip CoreHip Total Hip Arthroplasty 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
- Primary Outcome Measures
Name Time Method Change of Hip Joint Function measured by Harris Hip Score over time (HHS) Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative 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).
- Secondary Outcome Measures
Name Time Method Restoration of preoperative leg length preoperative and 3 months postoperative Comparison of preoperative and postoperative leg length
Restoration of preoperative offset preoperative and 3 months postoperative Comparison of preoperative and postoperative Offset angle of the femoral neck
Change of Oxford Hip Score (OHS) over time Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative 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).
Survival Rate of the Hip Prosthesis up to five years Survival Analysis of stems in-situ throughout the follow-up period
Change of Quality of Life (EQ-5D-5L) over time Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative 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.
Development of Radiological results: radiolucent lines Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative Development of radiolucent lines ("Gruen" zones) in AP and lateral x-rays throughout the follow-up period
Adverse Events up to five years documentation of all product related adverse Events occuring with the Hip Prosthesis throughout the follow-up period
Change of Radiological results: implant position Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative Changes in implant Position throughout the follow-up period
Trial Locations
- Locations (6)
St. Josefs Krankenhaus Endoprothetik Zentrum
🇩🇪Salzkotten, Germany
MHH
🇩🇪Hannover, Niedersachsen, Germany
Orthopädische Chirurgie München
🇩🇪München, Bayern, Germany
Spital Brig
🇨🇭Brig, Switzerland
Luzerner Kantonsspital Sursee
🇨🇭Sursee, Switzerland
Ortrhopädische Klinik Markgröningen
🇩🇪Markgröningen, Baden-Württemberg, Germany