An interventional study of The H1 Implant and Cementless total hip replacement in Osteoarthritis, Hip and Inflammatory Arthritis, sponsored by Embody Orthopaedic Limited. Recruiting at 3 sites in United Kingdom. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Embody Orthopaedic Limited · Not applicable, Interventional, and Treatment
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.
The H1 Implant is a cementless, ceramic hip resurfacing arthroplasty (HRA) device. The intended purpose of the H1 Implant is to provide an artificial substitute for a disease-damaged hip joint to replace the articulating surfaces of the hip while preserving the underlying femoral head and natural femoral neck. This is standard for a resurfacing hip prosthesis. This study will randomise patients to receive either The H1 Implant or a primary cementless ceramic-on-poly or ceramic-on-ceramic total hip replacement (THR). Composite clinical success (CCS) scores, physical activity levels and patient reported outcome measures (PROMs) will be compared for the two groups. The primary objective of the study is to determine whether the H1 Implant is non-inferior to cementless THR in terms of CCS. The key secondary objective is to determine whether the H1 Implant is superior compared to cementless THR in terms of physical activity and PROMs. Other secondary objectives are to compare the H1 Implant and THR with respect to: safety, through collection of all device-related, operative site-related and systemic adverse events; and noise generation, through patient survey.
641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.
This study's planned enrollment of 200 is above the median of 90 across 457 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Embody Orthopaedic Limited is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cementless, ceramic-on-ceramic hip resurfacing arthroplasty (HRA) device.
Device: The H1 Implant
Cementless ceramic-on-poly or ceramic-on-ceramic total hip replacement
Device: Cementless total hip replacement
Patients allocated to The H1 Implant arm will be implanted with the H1 Implant which is a cementless, ceramic hip resurfacing device.
Patients allocated to cementless total hip replacement arm will be implanted with a cementless ceramic-on-poly or ceramic-on-ceramic total hip replacement
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-operatively
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-operatively
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-operatively
Physical Activity
Hip Outcome Score (HOS) Questionnaire
Time frame: Pre-operatively, 6 months, 12 months and 24 months post-operatively
Physical Activity
UCLA (University of California Los Angeles) Activity Score
Time frame: Pre-operatively, 6 months, 12 months and 24 months post-operatively
Noise
Noise questionnaire
Time frame: 6 weeks, 6 months, 12 months and 24 months post-operatively
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Dec 2028, 29 months after the start.
Of 226 interventional studies with no phase under Osteoarthritis, Hip, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 51. This study's planned 29 months is close to that.
How these figures are worked out, and which studies are left out of them.
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Embody Orthopaedic Limited