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

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Device: Ceramic On Metal; Device: Metal on Metal

• Registration Number: NCT00754520
• Lead Sponsor: Zimmer Biomet

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2008-09-16
• Study First Submitted QC: 2008-09-16
• Study First Posted: 2008-09-18
• Study Start: 2009-05
• Primary Completion: 2021-12
• Study Completion: 2021-12
• Results First Submitted: 2023-12-01
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-01
• Last Update Submitted: 2024-07-01
• Results First Posted: 2024-10-02
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ceramic On Metal	Ceramic On Metal	This arm utilizes the ceramic on metal articulation using the M2a-38™ mm cup.
Metal on Metal	Metal on Metal	This arm utilizes the metal on metal articulation using M2a-38™ mm cup.

Primary Outcome Measures

Name	Time	Method
Composite Clinical Success (CCS) Rate as Defined in the Protocol	2 years post-operatively	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

Secondary Outcome Measures

Name	Time	Method
Oxford Hip Score	pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively	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.
Womac Score	pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively	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.
Metal Ion Concentrations in Blood	6 months post-operatively, 1, 2, 3 and 5 years post-operatively	Chromium and Cobalt concentrations in blood are measured in measurement unit nmol/L. The change from baseline analysis is presented.
Survivorship	10 years post-op	Survival of the implant based on the removal or intended removal of the device. The percentage of patients that still have the implant 10 years post-operative is presented here.

Trial Locations

Locations (3)

Central Finland Central Hospital; 🇫🇮 Jyvaskyla, Finland

Kymenlaakso Central Hospital; 🇫🇮 Kotka, Finland

North Hampshire Hospital; 🇬🇧 Basingstoke, United Kingdom