Health TrialsbyHealthPanel

A Register Based Prospective Study During Implementation of a New Cup

ConditionProspective
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-75
SponsorSahlgrenska University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Total hip arthroplasty

    Device

    Total hip arthroplasty with a Trident II hemispherical cup

  • Total hip arthroplasty

    Device

    Total hip arthroplasty with a Trident II Tritanium cup

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Trident II Hemispherical cup (Stryker Orthopaedics)Active comparator 1 intervention
Group B: Trident II Tritanium cup (Stryker Orthopaedics)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Implant survival at 3 years

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

Time frame
3 years

Secondary outcomes

1

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

Time frame
CTMA will be done postoperatively, 3 month and 6 months and 2 years after total hip replacement
2

Implant survival at 10 years

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

Time frame
10 years
3

EQ-5D

Patient-reported generic health outcome measure

Time frame
10 years
4

Plain radiographs in a sub-cohort of patients

Using plain radiographs to evaluate signs of loosening and implant position

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sahlgrenska University Hospital

Lead sponsor

Stryker Nordic

Collaborator

Source ClinicalTrials.gov
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