The ACTIVE trial: a prospective randomised control trial of the H1 implant versus total hip replacement

Embody Orthopaedic0 sites200 target enrollmentJanuary 4, 2024

Overview

No summary available.

Registry

who.int

Start Date

January 4, 2024

End Date

April 1, 2035

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Embody Orthopaedic

•1\. Patient requires unilateral primary hip arthroplasty due to primary osteoarthritis, osteoarthritis secondary to e.g. trauma, avascular necrosis or developmental hip dysplasia, or inflammatory arthritis
•2\. Patient is willing to comply with study requirements
•3\. Patient plans to be available through 24 months postoperative follow\-up

•1\. Patient has a BMI greater than 40 kg/m²
•2\. Patient has active infection or sepsis (treated or untreated)
•3\. Patient has insufficient bone stock at the hip (\>1/3 necrosis of the femoral head or large and multiple cysts) or in general as in severe osteopenia or osteoporosis (Tscore \< \-2\.5 as measured with BMD)
•4\. Patient is not skeletally mature
•5\. Patient meets the contraindication criteria of the control device
•6\. Patient already has another lower limb arthroplasty or arthrodesis or will require a further lower limb arthroplasty or arthrodesis within the subsequent 2 years
•7\. Patient lacks capacity to consent
•8\. Patient is unable to understand the native language of the country where their procedure is taking place