A Study Comparing Ceramic-on-metal Articulation to Metal-on-metal Articulation in Cementless Primary Hip Arthroplasty

Zimmer Biomet213 enrolled

Overview

The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup.

The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup in regards to the composite clinical success (CCS) rate, as defined in the protocol, at 2 year postoperative.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

213

Conditions

Osteoarthritis

Interventions

Ceramic On MetalDEVICE

Ceramic on Metal articulation using M2a-38™ mm cup

Metal on MetalDEVICE

Metal on Metal articulation using M2a-38™ mm cup

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients presenting with osteoarthritis and suitable for primary Total Hip Replacement * Patients preoperative Harris Hip Score \<= 70 points * Patients aged over 18 and under 75 * Patients with limited co-morbidity - ASA I-III * Patients with normal urea and electrolyte levels and creatinine levels * Patients must be able to understand instructions and be willing to return for follow-up * Patients willing to provide blood and urine samples for metal ion analysis at follow up Exclusion Criteria: * Patients preoperative Harris Hip Score \> 70 points * Previous prosthetic hip surgery * Patients with significant co-morbidity - ASA IV - V * Dementia and inability to understand and follow instructions * Neurological conditions affecting movement * Existing metal implant or fixation device * Pregnancy * Presence of symptomatic arthritis in other lower limb joints

Locations (3)

Central Finland Central Hospital

Jyväskylä, Finland

Kymenlaakso Central Hospital

Kotka, Finland

North Hampshire Hospital

Basingstoke, United Kingdom

Outcomes

Primary Outcomes

Composite Clinical Success (CCS) Rate as Defined in the Protocol

CCS is defined as: a. Total Harris Hip Score \> 80 points, and b. No acetabular or femoral revision or removal, and c. No pending acetabular or femoral revision or removal as defined in radiographic evaluation by: i. An acetabular radiographic assessment with all of the following: 1. Migration \< 4 mm, and 2. Change in angle of inclination \< 4o, and 3. Absence of osteolysis, and ii. A femoral radiographic assessment with all of the following: 1\. Subsidence \< 5 mm, and 2. Absence of osteolysis. The HHS including a series of questions answered by the patient and physical examinations recorded by a qualified health care professional covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \< 70

Time frame: 2 years post-operatively

Secondary Outcomes

Oxford Hip Score

The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: \> 41; Good: 34 - 41; Fair: 27 - 33; Poor: \< 27.

Time frame: pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively

Womac Score

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC score) is a standardised patient reported outcome measure consisting of 24 items divided into 3 sub-sections: Pain (5 items), stiffness (2 items) and physical function or "Activities of Daily Living; ADL" (17 items). A higher score indicates a worse clinical outcome. The maximum score for each subsection is Pain: 20 - 0; Stiffness: 8 - 0; ADL: 68 - 0.

Data from ClinicalTrials.gov

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