Degenerative Osteoarthritis, Fractures, Hip, Necrosis, Femur Head, Rheumatic Arthritis
Conditions
Keywords
Hip Arthroplasty, Hip Prosthesis
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.
Interventions
DEVICECoreHip Total Hip Arthroplasty
Replacement of the Hip Joint
Sponsors
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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 |
| 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 |
| Survival Rate of the Hip Prosthesis | up to five years | Survival Analysis of stems in-situ throughout the follow-up period |
Countries
Germany, Switzerland
Contacts
PRINCIPAL_INVESTIGATORHenning Windhagen, Prof. Dr. med.
Orthopädische Kliniken im Annastift, Medizinische Hochschule Hannover
Outcome results
None listed