Prospective Multicenter Study Evaluating Trident II Cups in Total Hip Replacement for Adults Aged 30 to 75

What this Trial Is About

Researchers are conducting a prospective study to evaluate the survival and clinical outcomes of hip implants, specifically the Trident II cup, in patients undergoing total hip replacement. The study aims to follow a group of at least 500 patients from several high-volume centers in Sweden to assess implant performance and patient health over time. The focus is on comparing two types of non-cemented Trident II acetabular cups and determining if there is any evidence of inferiority according to orthopedic benchmarking standards. Participants will receive total hip arthroplasty using either the Trident II Hemispherical cup or the Trident II Tritanium cup. Clinical data such as the EQ-5D, Oxford Hip Score, and Forgotten Joint Score will be collected before surgery and at 1, 3, 6, and 10 years afterwards. Imaging assessments including conventional X-rays will be performed before surgery, immediately after, and at 3, 6, and 10 years post-operation. Additionally, a subgroup of patients will undergo detailed implant migration analysis using Computer Tomography Microanalysis CTMA at postoperative, 3 months, 6 months, and 2 years. Throughout the study, participants will undergo regular evaluations involving clinical questionnaires, X-rays, and CT scans for those in the sub-cohort. The main outcome measured is implant survival at 3 years, with additional monitoring extending to 10 years for survival, quality of life scores, radiographic findings, and adverse events from national and regional patient registries. The total participation period can last up to 10 years, with multiple follow-up visits planned to closely monitor implant performance and patient well-being.

A Register Based Prospective Study During Implementation of a New Cup