NCT06162195

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Embody Orthopaedic Limited · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	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.
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

Timeline

• Start date: 2024-09-01
• Primary completion: 2027-04-01
• Completion: 2035-04-01
• First posted: 2023-12-08
• Last updated: 2023-12-08