DEXA Bone Density Analysis of the CoreHip® Prosthesis System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Primary hip replacement with cementless stem.
- Who it may be relevant to
- Registry conditions: Primary Osteoarthritis, Cartilage Degeneration, Osteoarthritis, Hip, Inflammatory Arthritis. Basic parameters: 35 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
DEXA Bone Density Analysis to Analyze the Loading Concept of the CoreHip® Prosthesis
Overview
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
- Device Primary hip replacement with cementless stem
Total Hip Arthroplasty is today one of the most established surgical orthopaedic procedures worldwide.
Primary outcome measures
- Radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4) [Time frame: within 24 months postoperative]
Secondary outcome measures (5)
- Clinical Results: Joint Function (Harris Hip Score) [Time frame: preoperative, at discharge (1 week postop) and 12 months postoperative]
- Development of Quality of Life (EQ-5D-5L) [Time frame: preoperative, at discharge (1 week postop) and 12 months postoperative]
- Development of Forgotten Joint Score [Time frame: preoperative, at discharge (1 week postop) and 12 months postoperative]
- Development of Pain [Time frame: preoperative, at discharge (1 week postop) and 12 months postoperative]
- Development of Pain [Time frame: preoperative, at discharge (1 week postop) and 12 months postoperative]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Germany · 1 center
- Medizinische Hochschule Hannover — Hanover
Identifiers
NCT: NCT06632301 · AAG-G-H-23009