The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement

Launched by EMBODY ORTHOPAEDIC LIMITED · Dec 6, 2023

Keywords

ClinConnect Summary

The ACTIVE Trial is a study designed to compare two types of hip replacement surgeries for patients suffering from hip arthritis. It aims to find out if a new procedure called hip resurfacing is just as effective as the traditional total hip replacement. In this trial, participants will receive either the new hip resurfacing or the conventional total hip replacement, and researchers will look at how well each method works, including how active and functional patients are after their surgery and any complications that may arise.

To be eligible for this trial, participants should need a hip replacement due to conditions like osteoarthritis or inflammatory arthritis and should be willing to stay in touch for up to 10 years after the surgery. However, individuals with a body mass index (BMI) over 40, certain bone issues, active infections, or those who have had other significant leg surgeries recently won’t qualify. If you or a loved one is considering participation, it’s essential to know that the study is not yet recruiting, but it offers a chance to contribute to important research that may help others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • Patient is willing to comply with study requirements.
• • Patient plans to be available through 10 years postoperative follow-up.
• Exclusion Criteria:
• • Patient has a BMI greater than 40 kg/m².
• • Patient has active infection or sepsis (treated or untreated).
• • 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 (t-score \< -2.5 as measured with BMD).
• • Patient is not skeletally mature.
• • Patient meets the contraindication criteria of the control device.
• • Patient already has another lower limb arthroplasty or arthrodesis or will require a further lower limb arthroplasty or arthrodesis within the subsequent 2 years.
• • Patient lacks capacity to consent.
• • Patient is unable to understand the native language of the country where their procedure is taking place