The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
The H1 Implant
DevicePatients allocated to The H1 Implant arm will be implanted with the H1 Implant which is a cementless, ceramic hip resurfacing device.
Cementless total hip replacement
DevicePatients allocated to cementless total hip replacement arm will be implanted with a cementless ceramic-on-poly or ceramic-on-ceramic total hip replacement
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: The H1 ImplantExperimental treatment 1 intervention
Group B: Cementless total hip replacementActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite clinical success (CCS)
The primary outcome is "composite clinical success". This is a binary outcome measure. Patients are deemed to have achieved CCS if they meet all of the following criteria at the 24 month timepoint: * Modified Harris Hip Score ≥80. * No revision or pending revision. * Acetabular radiolucencies: not in all zones. * Femoral radiolucencies: not in all zones. * Absence of subsidence/migration of the acetabular or femoral component \>5mm with clinical findings. * Absence of specific adverse device effects (ADEs) that are pre-cursors to revision of the device, namely: * Bone breakage around the implanted component(s) (periprosthetic fracture). * Breakage of the device component. * Device movement/migration of clinical consequence as defined by associated clinical findings as: a limp; leg length discrepancy; and restricted range of motion. * Dislocation of the hip joint.
Time frame
24 months post-operativelySecondary outcomes
1
Physical Activity
Average daily minutes of activity and mean bouted daily moderate-vigorous physical activity (MVPA), minutes
Time frame
6 months, 12 months and 24 months post-operatively2
Physical Activity
Physical performance assessment: number of chair stands in 30 seconds and time taken to perform stair climb test
Time frame
Pre-operatively, 6 months, 12 months and 24 months post-operatively3
Physical Activity
Hip Outcome Score (HOS) Questionnaire
Time frame
Pre-operatively, 6 months, 12 months and 24 months post-operatively4
Physical Activity
UCLA (University of California Los Angeles) Activity Score
Time frame
Pre-operatively, 6 months, 12 months and 24 months post-operativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Embody Orthopaedic Limited
Lead sponsor
Imperial College London
Collaborator
National Institute for Health Research, United Kingdom
Collaborator
Source ClinicalTrials.gov