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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:
Information provided by (Responsible Party):
Zimmer Biomet
ClinicalTrials.gov Identifier:
NCT00754520
First received: September 16, 2008
Last updated: March 6, 2017
Last verified: April 2016
  Purpose
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 Intervention
Osteoarthritis
Device: Ceramic On Metal
Device: Metal on Metal

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Further study details as provided by Zimmer Biomet:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 212
Study Start Date: May 2009
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00754520     History of Changes
Other Study ID Numbers: BMETEU.CR.EU11
Study First Received: September 16, 2008
Last Updated: March 6, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

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

ClinicalTrials.gov processed this record on May 25, 2017