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Not yet recruiting NCT06162195

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

No phase Interventional Osteoarthritis, Hip Inflammatory Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The H1 Implant, Cementless total hip replacement.
Who it may be relevant to
Registry conditions: Osteoarthritis, Hip, Inflammatory Arthritis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Composite clinical success (CCS) [Time frame: 24 months post-operatively]
Secondary outcome measures (5)
  • Physical Activity [Time frame: 6 months, 12 months and 24 months post-operatively]
  • Physical Activity [Time frame: Pre-operatively, 6 months, 12 months and 24 months post-operatively]
  • Physical Activity [Time frame: Pre-operatively, 6 months, 12 months and 24 months post-operatively]
  • Physical Activity [Time frame: Pre-operatively, 6 months, 12 months and 24 months post-operatively]
  • Noise [Time frame: 6 weeks, 6 months, 12 months and 24 months post-operatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06162195 · 327954

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗