Status:
UNKNOWN
Metal Ion Levels in Total Hip Arthroplasty (THA) With Modular Dual Mobility Cup Compared to Conventional THA
Lead Sponsor:
Korea University Guro Hospital
Collaborating Sponsors:
Stryker Korea Co., Ltd.
Conditions:
Femur Neck Fracture
Arthroplasty Complications
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
After total hip arthroplasty using an 'Modular Dual Mobility' acetabular cup, which is effective in reducing the risk of dislocation, one of the serious complications occurring after total hip arthrop...
Detailed Description
Dislocation after total hip arthroplasty is a very serious complication not only for the patient but also for the operator, and is the second most common complication after joint dissociation. The inc...
Eligibility Criteria
Inclusion
- Over 60 years of age. Femoral neck fracture or hip joint disease. Garden stage III, IV
- Comorbidities: American Society of Anesthesiology (ASA) grade III or less, Charlson comorbidity 6 points or less
- Daily activity: UCLA score 4 or higher, Koval score 4 or lower
- Including patients with neuromuscular disorder and cognitive impairment
Exclusion
- Revision arthroplasty
- In case of factors other than fretting corrosion of the index arthroplasty that can cause an increase in serum metal ion level - In case of undergoing surgery using metal on other joints before this operation, vitamin B user
- Patients with abnormal kidney function in which Blood urea nitrogen (BUN) and Cr are out of normal values
- Pathologic fracture
- If you have metabolic bone disorder, exclude osteoporosis (ex. Paraneoplastic syndrome, renal osteodystrophy, Vit D disorder, hormonal disorder)
Key Trial Info
Start Date :
September 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT05181566
Start Date
September 5 2019
End Date
December 31 2025
Last Update
January 6 2022
Active Locations (1)
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1
KoreaUGuroH
Seoul, South Korea, 08308