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

NCT ID: NCT06162195

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2035-04-30

Brief Summary

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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.

Detailed Description

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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

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Osteoarthritis, Hip Inflammatory Arthritis

Keywords

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Hip Resurfacing Ceramic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
The patients, clinical assessors and data analysts will be blinded to the intervention each patient has received for the 24 month post-operative period. The surgeon, operating theatre team, radiographic analysts and CRO cannot be blinded but will not be involved in the care of the patient after the intervention unless the patient requires revision surgery.

Study Groups

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The H1 Implant

Cementless, ceramic-on-ceramic hip resurfacing arthroplasty (HRA) device.

Group Type EXPERIMENTAL

The H1 Implant

Intervention Type DEVICE

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 replacement

Cementless ceramic-on-poly or ceramic-on-ceramic total hip replacement

Group Type ACTIVE_COMPARATOR

Cementless total hip replacement

Intervention Type 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

Interventions

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The H1 Implant

Patients allocated to The H1 Implant arm will be implanted with the H1 Implant which is a cementless, ceramic hip resurfacing device.

Intervention Type DEVICE

Cementless total hip replacement

Patients allocated to cementless total hip replacement arm will be implanted with a cementless ceramic-on-poly or ceramic-on-ceramic total hip replacement

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Embody Orthopaedic Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Justin Cobb, Prof

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Central Contacts

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Camilla Halewood, PhD

Role: CONTACT

Phone: +442075943600

Email: [email protected]

Mariam Al-Laith, PhD

Role: CONTACT

Phone: +442075943600

Email: [email protected]

Other Identifiers

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327954

Identifier Type: -

Identifier Source: org_study_id