A Register Based Prospective Study During Implementation of a New Cup

Prospective Clinical Trial

Official title:

STEISURE - Trident II - A Registerbased Multicentric Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04350255
• Other study ID #: STEISURE - Trident II
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: August 1, 2030

Study information

• Verified date: October 2022
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Maziar Mohaddes, MD, PhD
• Phone: +46730701147
• Email: maziar.mohaddes[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 1, 2030
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prospective

Intervention

Device:
• Total hip arthroplasty
Total hip arthroplasty with a Trident II hemispherical cup
• Total hip arthroplasty
Total hip arthroplasty with a Trident II Tritanium cup

Locations

Country	Name	City	State
Sweden	Department of Orthopaedics	Molndal	Västra Götaland

Sponsors (2)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Stryker Nordic

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival at 3 years	Kaplan Meier survival data, cup revision and risk of revision used as endpoints	3 years
Secondary	Implant migration measured with Computer Tomography Microanalysis in a subcohort of patients motion Analysis (CTMA) in a sub-cohort of patients	Using Computer Tomography Micro-motion Analysis (CTMA) to measure implant migration in a sub-cohort of patients	CTMA will be done postoperatively, 3 month and 6 months and 2 years after total hip replacement
Secondary	Implant survival at 10 years	Kaplan Meier survival data, cup revision and risk of revision used as endpoints	10 years
Secondary	EQ-5D	Patient-reported generic health outcome measure	10 years
Secondary	Plain radiographs in a sub-cohort of patients	Using plain radiographs to evaluate signs of loosening and implant position	10 years
Secondary	Adverse events using the national patient register	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	10 years
Secondary	Adverse events using the regional VEGA database	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	10 years
Secondary	Oxford Hip Score	Patient-reported hip specific outcome measure	10 years
Secondary	Forgotten Joint Score	Patient-reported hip specific outcome measure	10 years