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

NCT06162195 | Not Yet Recruiting

• 1 other identifier: 327954
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Osteoarthritis, Hip; Inflammatory Arthritis

Keywords

Hip; Resurfacing; Ceramic

Outcome Measures

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.

  24 months post-operatively

Secondary Outcomes (5)

• Physical Activity

  6 months, 12 months and 24 months post-operatively

• Physical Activity

  Pre-operatively, 6 months, 12 months and 24 months post-operatively

• Physical Activity

  Pre-operatively, 6 months, 12 months and 24 months post-operatively

• Physical Activity

  Pre-operatively, 6 months, 12 months and 24 months post-operatively

• Noise

  6 weeks, 6 months, 12 months and 24 months post-operatively

Study Arms (2)

The H1 Implant

EXPERIMENTAL

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

Device: The H1 Implant

Cementless total hip replacement

ACTIVE COMPARATOR

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

Device: Cementless total hip replacement

Interventions

The H1 Implant DEVICE

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

The H1 Implant

Cementless total hip replacement 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

Cementless total hip replacement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Embody Orthopaedic Limited: lead
• Imperial College London: collaborator
• National Institute for Health Research, United Kingdom: collaborator

MeSH Terms

Conditions

Osteoarthritis, Hip; Arthritis

Condition Hierarchy (Ancestors)

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Justin Cobb, Prof

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camilla Halewood, PhD

CONTACT

+442075943600; camilla.halewood@embody-ortho.com

Mariam Al-Laith, PhD

CONTACT

+442075943600; m.al-laith@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 8, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2035
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share