search
Back to results

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

Primary Purpose

Osteoarthritis

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ceramic On Metal
Metal on Metal
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central Finland Central Hospital
  • Kymenlaakso Central Hospital
  • North Hampshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ceramic On Metal

Metal on Metal

Arm Description

This arm utilizes the ceramic on metal articulation using the M2a-38™ mm cup.

This arm utilizes the metal on metal articulation using M2a-38™ mm cup.

Outcomes

Primary Outcome Measures

Composite Clinical Success (CCS) Rate as defined in the protocol

Secondary Outcome Measures

Oxford Hip Score
Womac Score
Metal Ion concentrations in blood and urine
Measurement of cellular markers in blood
Complications
Survivorship

Full Information

First Posted
September 16, 2008
Last Updated
February 3, 2022
Sponsor
Zimmer Biomet
search

1. Study Identification

Unique Protocol Identification Number
NCT00754520
Brief Title
A Study Comparing Ceramic-on-metal Articulation to Metal-on-metal Articulation in Cementless Primary Hip Arthroplasty
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2009 (undefined)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ceramic On Metal
Arm Type
Experimental
Arm Description
This arm utilizes the ceramic on metal articulation using the M2a-38™ mm cup.
Arm Title
Metal on Metal
Arm Type
Active Comparator
Arm Description
This arm utilizes the metal on metal articulation using M2a-38™ mm cup.
Intervention Type
Device
Intervention Name(s)
Ceramic On Metal
Intervention Description
Ceramic on Metal articulation using M2a-38™ mm cup
Intervention Type
Device
Intervention Name(s)
Metal on Metal
Intervention Description
Metal on Metal articulation using M2a-38™ mm cup
Primary Outcome Measure Information:
Title
Composite Clinical Success (CCS) Rate as defined in the protocol
Time Frame
6 weeks, 6 months, annually up to 10 years
Secondary Outcome Measure Information:
Title
Oxford Hip Score
Time Frame
6 weeks, 6 months, annually up to 10 years
Title
Womac Score
Time Frame
6 weeks, 6 months, annually up to 10 years
Title
Metal Ion concentrations in blood and urine
Time Frame
6 weeks, 6 months, annually up to 10 years
Title
Measurement of cellular markers in blood
Time Frame
6 weeks, 6 months, annually up to 10 years
Title
Complications
Time Frame
Any Time
Title
Survivorship
Time Frame
Any Time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G. Stranks, FRCS
Organizational Affiliation
North Hampshire Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
M Pesola
Organizational Affiliation
Central Finland Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
H Kauppinen
Organizational Affiliation
Kymenlaakso Central Hospital Kotka Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Finland Central Hospital
City
Jyvaskyla
Country
Finland
Facility Name
Kymenlaakso Central Hospital
City
Kotka
Country
Finland
Facility Name
North Hampshire Hospital
City
Basingstoke
ZIP/Postal Code
RG24 9NA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31540737
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs