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The goal of this interventional post-market follow-up study is to evaluate radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4) within 24 months postoperative in patients treated with CoreHip® primary cementless stem. The DEXA bone density analysis is used.
Additional diagnostic examination: DEXA-Analysis. A DEXA scan is an imaging test that measures bone density (strength). The results can provide helpful details about risk for osteoporosis (bone loss) and fractures. Furthermore we would like to find out more about stress shielding processes around our prosthesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEXA | Experimental | DEXA bone density analysis to analyze the loading concept of the CoreHip® Prosthesis System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary hip replacement with cementless stem | Device | Total Hip Arthroplasty is today one of the most established surgical orthopaedic procedures worldwide. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4) | Changes in bone mineral density (BMD) according to Gruen. | within 24 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Results: Joint Function (Harris Hip Score) | The functional results of the operated hip will be assessed with the Harris Hip Score (HHS) and evaluated over time. | preoperative, at discharge (1 week postop) and 12 months postoperative |
| Development of Quality of Life (EQ-5D-5L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kerstin Bergmann | Contact | +49746195 | 0 | info@aesculap.de |
| Stefan Maenz | Contact | 0746195 | 0 | info@aesculap.de |
| Name | Affiliation | Role |
|---|---|---|
| Henning Windhagen, Prof. Dr. | Orthopädische Kliniken im Annastift, MHH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D001168 | Arthritis |
| D005271 | Femur Head Necrosis |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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The EQ-5D-5L score is a generic score used to document the well-being of the patient. |
| preoperative, at discharge (1 week postop) and 12 months postoperative |
| Development of Forgotten Joint Score | The EQ-5D-5L score is a generic score used to document the well-being of the patient. | preoperative, at discharge (1 week postop) and 12 months postoperative |
| Development of Pain | The development of pain is measured with the Visual analog scale [VAS] a measure of pain intensity. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale]. | preoperative, at discharge (1 week postop) and 12 months postoperative |
| Development of Pain | Radiological changes in the diaphyseal bone density (DEXA BMD progression over time in all Gruen Zones (Zone 1-7) | preoperative, at discharge (1 week postop) and 12 months postoperative |
| D010020 |
| Osteonecrosis |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |