Osteoarthritis, HipACTIVENCT06162195
The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement
A study testing The H1 Implant and Cementless total hip replacement in people with Osteoarthritis, Hip and Inflammatory Arthritis, run by Embody Orthopaedic Limited at 3 sites in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Hip, Inflammatory Arthritis
- What is being tested?
- The H1 Implant and Cementless total hip replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 21 Jul 2026to 31 Dec 2036
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom3 sites, 3 recruiting
- Recruiting
University Hospitals Dorset NHS Foundation Trust
Bournemouth
- Recruiting
University Hospitals Coventry & Warwickshire
Coventry
- Recruiting
Royal Cornwall Hospitals NHS Trust
Truro
About this study
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.
Read the detailed description
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.
- Conditions
- Osteoarthritis, Hip, Inflammatory Arthritis
- Being tested
- The H1 Implant, Cementless total hip replacement
- Keywords
- Hip, Resurfacing, Ceramic
- Medical subject headings
- Osteoarthritis, Hip, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The H1 ImplantDevice
Patients allocated to The H1 Implant arm will be implanted with the H1 Implant which is a cementless, ceramic hip resurfacing device.
Cementless total hip replacementDevice
Patients allocated to cementless total hip replacement arm will be implanted with a cementless ceramic-on-poly or ceramic-on-ceramic total hip replacement
| Study group | Role | What they receive |
|---|---|---|
| The H1 Implant | Experimental | Cementless, ceramic-on-ceramic hip resurfacing arthroplasty (HRA) device. Receives: Device: The H1 Implant |
| Cementless total hip replacement | Active comparator | Cementless ceramic-on-poly or ceramic-on-ceramic total hip replacement Receives: Device: Cementless total hip replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months post-operatively
Secondary outcomes (5)
Physical Activity
Average daily minutes of activity and mean bouted daily moderate-vigorous physical activity (MVPA), minutes
Measured: 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
Measured: Pre-operatively, 6 months, 12 months and 24 months post-operatively
Physical Activity
Hip Outcome Score (HOS) Questionnaire
Measured: Pre-operatively, 6 months, 12 months and 24 months post-operatively
Physical Activity
UCLA (University of California Los Angeles) Activity Score
Measured: Pre-operatively, 6 months, 12 months and 24 months post-operatively
Noise
Noise questionnaire
Measured: 6 weeks, 6 months, 12 months and 24 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start21 Jul 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomisation will be performed using variable block randomisation with block sizes of 4, 6 and 8, with a 1:1 allocation to the 2 groups, with stratification across sites. This will ensure approximately equal numbers across groups and approximately the same number per group at each site (to control for differences in the trial population because of environmental, social and demographic factors), while allowing different total numbers at each site. It will also ensure that at any given time, the numbers in each group will be approximately equal, allowing the interim analyses to take place. The randomisation will be managed by the contract research organisation (CRO) via an electronic data capture (EDC) system, which uses a validated randomisation algorithm. Once a patient has been consented, they will be assigned to a treatment group according to the pre-determined order inside the block. Stratification by site is recommended for multi-centre studies.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Embody Orthopaedic Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Imperial College London, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Justin Cobb, Prof, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162195
- Sponsor's protocol ID
- 327954
- Acronym
- ACTIVE
- Status last verified
- Aug 2026
- First submitted
- 29 Nov 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No