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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorEmbody Orthopaedic Limited

About this trial

The goal of this randomised controlled trial is to compare the success of two types of hip replacement in patients with hip arthritis. The main question it aims to answer is whether a new type of hip replacement (called a hip resurfacing) can be as successful as an existing hip replacement (called a total hip replacement). Patients will be given either the new hip resurfacing or the existing total hip replacement and researchers will compare their function, complication rate and physical activity.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • The H1 Implant
  • Cementless total hip replacement

Treatment groups

200 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Embody Orthopaedic Limited

Lead sponsor

Imperial College London

Collaborator

National Institute for Health Research, United Kingdom

Collaborator