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

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ClinicalTrials.gov Identifier: NCT00754520
Recruitment Status : Active, not recruiting
First Posted : September 18, 2008
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Ceramic On Metal Device: Metal on Metal Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2009
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ceramic On Metal
This arm utilizes the ceramic on metal articulation using the M2a-38™ mm cup.
Device: Ceramic On Metal
Ceramic on Metal articulation using M2a-38™ mm cup

Active Comparator: Metal on Metal
This arm utilizes the metal on metal articulation using M2a-38™ mm cup.
Device: Metal on Metal
Metal on Metal articulation using M2a-38™ mm cup




Primary Outcome Measures :
  1. Composite Clinical Success (CCS) Rate as defined in the protocol [ Time Frame: 6 weeks, 6 months, annually up to 10 years ]

Secondary Outcome Measures :
  1. Oxford Hip Score [ Time Frame: 6 weeks, 6 months, annually up to 10 years ]
  2. Womac Score [ Time Frame: 6 weeks, 6 months, annually up to 10 years ]
  3. Metal Ion concentrations in blood and urine [ Time Frame: 6 weeks, 6 months, annually up to 10 years ]
  4. Measurement of cellular markers in blood [ Time Frame: 6 weeks, 6 months, annually up to 10 years ]
  5. Complications [ Time Frame: Any Time ]
  6. Survivorship [ Time Frame: Any Time ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754520


Locations
Finland
Central Finland Central Hospital
Jyvaskyla, Finland
Kymenlaakso Central Hospital
Kotka, Finland
United Kingdom
North Hampshire Hospital
Basingstoke, United Kingdom, RG24 9NA
Sponsors and Collaborators
Zimmer Biomet
Investigators
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

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00754520     History of Changes
Other Study ID Numbers: BMETEU.CR.EU11
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases