None listed
Conditions
Interventions
Medical Device : This clinical study is designed as a single-blinded trial. Randomization will be performed by an independent statistician who is not directly involved in the conduct of this study, us
Sponsors
Korea University Anam Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Individuals who have received an explanation of the overview of this clinical study and have voluntarily signed the informed consent form. Adult men and women aged 60 years or older. Patients requiring total hip arthroplasty due to hip disease.
Exclusion criteria
Exclusion criteria: Individuals with sepsis, active infection, or osteomyelitis in the joint lesion. Individuals with poor or insufficient bone quality such that fixation of an uncemented acetabular cup is not feasible, as judged by the investigator. Individuals with metabolic disorders that may impair bone formation. Individuals with osteomalacia. Individuals with a focus of infection at another site that could spread to the prosthetic joint. Individuals with acute joint destruction, significant bone loss, or bone resorption observed on preoperative radiographs. Individuals with vascular insufficiency or muscle atrophy at the implant site, or with neuromuscular disorders that may compromise surgical outcomes. Individuals with comorbidities that may interfere with the function of the prosthesis or the success of the arthroplasty. Individuals with hypersensitivity or allergy to any of the implant materials, including chromium, cobalt, or ceramic components. Individuals unable to understand the details of the clinical study or provide voluntary informed consent due to cognitive impairment or other reasons. Individuals who have participated in another clinical trial within 1 month prior to screening. Individuals deemed ineligible for participation by the principal investigator. Individuals undergoing revision total hip arthroplasty. Individuals who have a prosthetic joint at another site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum cobalt and chromium levels at 12 months after surgery relative to screening | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the incidence of dislocation up to 12 months post-surgery relative to screening;Comparison of the Harris Hip Score (HHS) at 12 months relative to screening;Comparison of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months post-surgery relative to screening;Comparison of the Koval ambulation score at 12 months relative to screening;Incidence of liner malposition on postoperative CT;Acetabular cup anteversion angle and inclination measured on postoperative CT;Comparison of radiographic outcomes compared with screening (periprosthetic fracture, osteolysis, prosthetic loosening, and local tissue reactions) | — |
Countries
Korea, Republic of
Contacts
Public ContactEunJu Choi
Korea University Anam Hospital
Outcome results
None listed