A Study Comparing Ceramic-on-metal Articulation to Metal-on-metal Articulation in Cementless Primary Hip Arthroplasty
A Multi-center Prospective Randomized Control Trial to Compare Two Articulating Bearing Surfaces, Ceramic-on-metal and Metal-on-metal as Used in Cementless Primary Hip Arthroplasty
1 other identifier
interventional
213
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2009
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2008
CompletedFirst Posted
Study publicly available on registry
September 18, 2008
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedResults Posted
Study results publicly available
October 2, 2024
CompletedOctober 2, 2024
July 1, 2024
12.6 years
September 16, 2008
December 1, 2023
July 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
2 years post-operatively
Secondary Outcomes (4)
Oxford Hip Score
pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively
Womac Score
pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively
Metal Ion Concentrations in Blood
6 months post-operatively, 1, 2, 3 and 5 years post-operatively
Survivorship
10 years post-op
Study Arms (2)
Ceramic On Metal
EXPERIMENTALThis arm utilizes the ceramic on metal articulation using the M2a-38™ mm cup.
Metal on Metal
ACTIVE COMPARATORThis arm utilizes the metal on metal articulation using M2a-38™ mm cup.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (3)
Central Finland Central Hospital
Jyväskylä, Finland
Kymenlaakso Central Hospital
Kotka, Finland
North Hampshire Hospital
Basingstoke, RG24 9NA, United Kingdom
Related Publications (1)
Higgins JE, Conn KS, Britton JM, Pesola M, Manninen M, Stranks GJ. Early Results of Our International, Multicenter, Multisurgeon, Double-Blinded, Prospective, Randomized, Controlled Trial Comparing Metal-on-Metal With Ceramic-on-Metal in Total Hip Arthroplasty. J Arthroplasty. 2020 Jan;35(1):193-197.e2. doi: 10.1016/j.arth.2019.08.002. Epub 2019 Aug 22.
PMID: 31540737DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Project Lead
- Organization
- Zimmer Biomet
Study Officials
- PRINCIPAL INVESTIGATOR
G. Stranks, FRCS
North Hampshire Hospital
- PRINCIPAL INVESTIGATOR
M Pesola
Central Finland Central Hospital
- PRINCIPAL INVESTIGATOR
H Kauppinen
Kymenlaakso Central Hospital Kotka Finland
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2008
First Posted
September 18, 2008
Study Start
May 1, 2009
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
October 2, 2024
Results First Posted
October 2, 2024
Record last verified: 2024-07