A Register Based Prospective Study During Implementation of a New Cup

Sponsor

Sahlgrenska University Hospital, Sweden (Other)

Overall Status

Recruiting

CT.gov ID

NCT04350255

Collaborator

Stryker Nordic (Industry)

500

Enrollment

Location

Arms

120

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prospective	Device: Total hip arthroplasty Device: Total hip arthroplasty	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

STEISURE - Trident II - A Registerbased Multicentric Prospective Study

Actual Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Trident II Hemispherical cup (Stryker Orthopaedics) Total hip arthroplasty using non cemented Trident II Hemispherical acetabular cup	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
Active Comparator: Trident II Tritanium cup (Stryker Orthopaedics) Total hip arthroplasty using non cemented Trident II Tritanium acetabular cup	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

Arm

Intervention/Treatment

Active Comparator: Trident II Hemispherical cup (Stryker Orthopaedics)

Total hip arthroplasty using non cemented Trident II Hemispherical acetabular cup

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

Active Comparator: Trident II Tritanium cup (Stryker Orthopaedics)

Total hip arthroplasty using non cemented Trident II Tritanium acetabular cup

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

Outcome Measures

Primary Outcome Measures

Implant survival at 3 years [3 years]
Kaplan Meier survival data, cup revision and risk of revision used as endpoints

Secondary Outcome Measures

Implant migration measured with Computer Tomography Microanalysis in a subcohort of patients motion Analysis (CTMA) in a sub-cohort of patients [CTMA will be done postoperatively, 3 month and 6 months and 2 years after total hip replacement]
Using Computer Tomography Micro-motion Analysis (CTMA) to measure implant migration in a sub-cohort of patients
Implant survival at 10 years [10 years]
Kaplan Meier survival data, cup revision and risk of revision used as endpoints
EQ-5D [10 years]
Patient-reported generic health outcome measure
Plain radiographs in a sub-cohort of patients [10 years]
Using plain radiographs to evaluate signs of loosening and implant position
Adverse events using the national patient register [10 years]
ICD codes för surgical and medical adverse events following primary total hip arthroplasty, as defined by the National Board of Health and Welfare will be merged with data in the SHAR (The Swedish Hip Arthroplasty Register). This database includes mainly secondary care visits
Adverse events using the regional VEGA database [10 years]
ICD (International Classification of Diseases) codes för surgical and medical adverse events following primary total hip arthroplasty, as defined by the National Board of Health and Welfare will be merged with data in the SHAR (The Swedish Hip Arthroplasty Register). This regional database includes all contacts (both within primary and secondary care) for patients living in the region of Western Sweden
Oxford Hip Score [10 years]
Patient-reported hip specific outcome measure
Forgotten Joint Score [10 years]
Patient-reported hip specific outcome measure

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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