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 the study, usi
Sponsors
Korea University Anam Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria Individuals who have received an explanation of the study overview and have voluntarily signed the informed consent form. Adult men and women aged 60 years or older. Patients requiring primary total hip arthroplasty due to hip disease.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1.Individuals with sepsis, active infection, or osteomyelitis in the joint lesion. 2.Individuals with osteoporosis or poor bone quality such that fixation of an uncemented acetabular cup is not feasible, as judged by the investigator. 3.Individuals with metabolic disorders that may impair bone formation. 4.Individuals with osteomalacia. 5.Individuals with a focus of infection at another site that could spread to the prosthetic joint. 6.Individuals with acute joint destruction, significant bone loss, or bone resorption observed on preoperative radiographs. 7.Individuals with vascular insufficiency or muscle atrophy at the implant site, or with neuromuscular disorders that may compromise surgical outcomes. 8.Individuals with comorbidities that may interfere with prosthesis function or the success of arthroplasty. 9.Individuals with hypersensitivity or allergy to any of the implant materials, including chromium, cobalt, or ceramic components. 10.Individuals unable to understand the study procedures or provide voluntary informed consent due to cognitive impairment or other reasons. 11.Individuals who have participated in another clinical trial within 1 month prior to screening. 12.Individuals deemed ineligible for participation by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of Harris Hip Score (HHS) at 12 months postoperatively versus baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of concomitant pharmacologic therapy for pain at 6 weeks and 3, 6, and 12 months postoperatively relative to baseline.;Comparison of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at 12 months after surgery compared with baseline.;Date of first ambulation after surgery;Comparison of radiographic outcomes( Periprosthetic fracture, osteolysis, vertical subsidence, varus/valgus migration, prosthesis loosening, and findings of local tissue reaction)relative to baseline | — |
Countries
Korea, Republic of
Contacts
Public ContactEunJu Choi
Korea University Anam Hospital
Outcome results
None listed