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NCT06632301
DEXA Bone Density Analysis of the CoreHip® Prosthesis System
Conditions: Primary Osteoarthritis, Cartilage Degeneration, Osteoarthritis, Hip, Inflammatory Arthritis, Osteonecrosis of Femoral Head, Traumatic Disorder
Sex: All
Ages: 35 Years – 85 Years
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Aesculap AG
Location: Medizinische Hochschule Hannover Hanover
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06632301). StuddyBuddy aggregates publicly available trial information.
