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Clinical Trials/NCT04350255
NCT04350255RecruitingNot Applicable

STEISURE - Trident II - A Registerbased Multicentric Prospective Study

Sahlgrenska University Hospital, Sweden2 sites in 1 country500 target enrollmentStarted: August 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
500
Locations
2
Primary Endpoint
Implant survival at 3 years

Study Overview

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.

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
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
30 Years to 75 Years (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Implant survival at 3 years

Time Frame: 3 years

Kaplan Meier survival data, cup revision and risk of revision used as endpoints

Secondary Outcomes

  • EQ-5D(10 years)
  • Adverse events using the regional VEGA database(10 years)
  • 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)
  • Plain radiographs in a sub-cohort of patients(10 years)
  • Implant survival at 10 years(10 years)
  • Adverse events using the national patient register(10 years)
  • Oxford Hip Score(10 years)
  • Forgotten Joint Score(10 years)

Investigators

Sponsor
Sahlgrenska University Hospital, Sweden
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maziar Mohaddes Ardebili

Sahlgrenska University Hospital, Sweden

Sahlgrenska University Hospital, Sweden

Study Sites (2)

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