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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00754520
First Posted: September 18, 2008
Last Update Posted: March 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zimmer Biomet
September 16, 2008
September 18, 2008
March 8, 2017
May 2009
June 2021   (Final data collection date for primary outcome measure)
Composite Clinical Success (CCS) Rate as defined in the protocol [ Time Frame: 6 weeks, 6 months, annually up to 10 years ]
Same as current
Complete list of historical versions of study NCT00754520 on ClinicalTrials.gov Archive Site
  • Oxford Hip Score [ Time Frame: 6 weeks, 6 months, annually up to 10 years ]
  • Womac Score [ Time Frame: 6 weeks, 6 months, annually up to 10 years ]
  • Metal Ion concentrations in blood and urine [ Time Frame: 6 weeks, 6 months, annually up to 10 years ]
  • Measurement of cellular markers in blood [ Time Frame: 6 weeks, 6 months, annually up to 10 years ]
  • Complications [ Time Frame: Any Time ]
  • Survivorship [ Time Frame: Any Time ]
Same as current
Not Provided
Not Provided
 
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
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Osteoarthritis
  • Device: Ceramic On Metal
    Ceramic on Metal articulation using M2a-38™ mm cup
  • Device: Metal on Metal
    Metal on Metal articulation using M2a-38™ mm cup
  • Experimental: Ceramic On Metal
    This arm utilizes the ceramic on metal articulation using the M2a-38™ mm cup.
    Intervention: Device: Ceramic On Metal
  • Active Comparator: Metal on Metal
    This arm utilizes the metal on metal articulation using M2a-38™ mm cup.
    Intervention: Device: Metal on Metal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
212
June 2021
June 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Finland,   United Kingdom
 
 
NCT00754520
BMETEU.CR.EU11
No
Not Provided
Plan to Share IPD: Undecided
Zimmer Biomet
Zimmer Biomet
Not Provided
Principal Investigator: G. Stranks, FRCS North Hampshire Hospital
Principal Investigator: M Pesola Central Finland Central Hospital
Principal Investigator: M Manninen Kymenlaakso Central Hospital Kotka Finland
Zimmer Biomet
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP