A Register Based Prospective Study During Implementation of a New Cup

STEISURE - Trident II - A Registerbased Multicentric Prospective Study

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.

Study Overview

• Status: Recruiting
• Conditions: Prospective
• Intervention / Treatment: Device: Total hip arthroplasty; Device: Total hip arthroplasty

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 Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maziar Mohaddes, MD, PhD; Phone Number: +46730701147; Email: maziar.mohaddes@gmail.com
• Study Contact Backup: Name: Adam Rosenbaum, MD; Phone Number: +46705330149; Email: adamrosenbaum81@gmail.com

Study Locations

• Sweden
  • Västra Götaland
    • Molndal, Västra Götaland, Sweden, S-43180
      • Recruiting
      • Department of Orthopaedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival at 3 years	Kaplan Meier survival data, cup revision and risk of revision used as endpoints	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Implant survival at 10 years	Kaplan Meier survival data, cup revision and risk of revision used as endpoints	10 years
EQ-5D	Patient-reported generic health outcome measure	10 years
Plain radiographs in a sub-cohort of patients	Using plain radiographs to evaluate signs of loosening and implant position	10 years
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
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
Oxford Hip Score	Patient-reported hip specific outcome measure	10 years
Forgotten Joint Score	Patient-reported hip specific outcome measure	10 years

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Collaborators: Stryker Nordic

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2024
• Study Completion (ANTICIPATED): August 1, 2030

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (ACTUAL): April 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Patient reported outcomes; Hip arthroplasty; Clinical outcome; X-ray; Implant survival; Implant Migration
• Other Study ID Numbers: STEISURE - Trident II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to regulations associated with national registers in Sweden alla data will be presented on an aggregated level, individual patient data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No