Cartilage Degeneration, Inflammatory Arthritis, Osteoarthritis, Hip, Osteonecrosis of Femoral Head, Primary Osteoarthritis, Traumatic Disorder
Conditions
Keywords
Total Hip Arthroplasty, DEXA Bone Density Analysis
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPrimary hip replacement with cementless stem
Total Hip Arthroplasty is today one of the most established surgical orthopaedic procedures worldwide.
Sponsors
Aesculap AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Unilateral hip osteoarthritis * Indication for CoreHip Standard hip stem according to preoperative planning * Written Informed Consent * Age 35-85 years * According to the assessment of the study doctor, the patient is therapy compliant and able to attend the follow-up visits
Exclusion criteria
* Femoral neck fractures * Pregnancy * BMI \> 35 * History of femoral fracture or previous surgery on the same hip * Metabolic bone disease, use of steroids or other drugs affecting bone metabolism * Intraoperative bone cracks * Severe osteoarthritis of the contralateral hip * THA of the contralateral side or other event leading to restricted weight bearing during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4) | within 24 months postoperative | Changes in bone mineral density (BMD) according to Gruen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Results: Joint Function (Harris Hip Score) | preoperative, at discharge (1 week postop) and 12 months postoperative | The functional results of the operated hip will be assessed with the Harris Hip Score (HHS) and evaluated over time. |
| Development of Quality of Life (EQ-5D-5L) | preoperative, at discharge (1 week postop) and 12 months postoperative | The EQ-5D-5L score is a generic score used to document the well-being of the patient. |
| Development of Forgotten Joint Score | preoperative, at discharge (1 week postop) and 12 months postoperative | The EQ-5D-5L score is a generic score used to document the well-being of the patient. |
| Development of Pain | preoperative, at discharge (1 week postop) and 12 months postoperative | 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 \[on 100-mm scale\]. |
Countries
Germany
Contacts
CONTACTKerstin Bergmann
CONTACTStefan Maenz
PRINCIPAL_INVESTIGATORHenning Windhagen, Prof. Dr.
Orthopädische Kliniken im Annastift, MHH
Outcome results
None listed