A Register Based Prospective Study During Implementation of a New Cup

Sahlgrenska University Hospital

Status: Enrolling

Conditions: Prospective

Treatments: Device: Total hip arthroplasty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04350255

STEISURE - Trident II

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Primary hip replacement
• Eligible for uncemented fixation of the acetabular component
• Suitable for one of the stem designs from Stryker Orthopaedics
• Accepts follow-up according to the study protocol

Exclusion criteria

• Difficulties to understand written information due to language problems or other reasons
• Use of augments needed
• Acute hip fracture
• Tumor in the hip joint

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Trident II Hemispherical cup (Stryker Orthopaedics)

Active Comparator group

Description:

Total hip arthroplasty using non cemented Trident II Hemispherical acetabular cup

Treatment:

Device: Total hip arthroplasty

Device: Total hip arthroplasty

Trident II Tritanium cup (Stryker Orthopaedics)

Active Comparator group

Description:

Total hip arthroplasty using non cemented Trident II Tritanium acetabular cup

Treatment:

Device: Total hip arthroplasty

Device: Total hip arthroplasty