NCT04350255

A Register Based Prospective Study During Implementation of a New Cup

STEISURE - Trident II - A Registerbased Multicentric Prospective Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Sahlgrenska University Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Accepted

Summary

In a prospective register-based study, we aim to evaluate the implant survival, clinical outcomes and X-ray findings by following a cohort of patients operated with the Trident II cup.

Detailed description

Data will be collected from a cohort consisting of minimum 500 total hip arthroplasties. The patients will be recruited from multiple high volume centers in Sweden. To determine if there is evidence of inferiority as per benchmarking recommendations by The Orthopaedic Data Evaluation Panel the following parameters will be studied: Clinical parameters such as EQ-5D, Oxford Hip Score and Forgotten Joint Score, preoperative and after 1, 3, 6 and 10 years. Conventional radiography will be done preoperatively, postoperatively, 3, 6 and 10 years after total hip replacement. CTMA will be done postoperatively, 3 and 6 month and 2 years after total hip replacement.

Conditions

• Prospective

Interventions

Type	Name	Description
DEVICE	Total hip arthroplasty	Total hip arthroplasty with a Trident II hemispherical cup
DEVICE	Total hip arthroplasty	Total hip arthroplasty with a Trident II Tritanium cup

Timeline

• Start date: 2020-08-01
• Primary completion: 2024-12-01
• Completion: 2030-08-01
• First posted: 2020-04-17
• Last updated: 2022-10-04

Locations

1 site across 1 country: Sweden