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Metal on Metal Versus Metal on Highly Crossed Linked Polyethylene Sytem (MOM)

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.
ClinicalTrials.gov Identifier: NCT01422564
Recruitment Status : Terminated (Components were recalled by Depuy)
First Posted : August 24, 2011
Last Update Posted : May 15, 2015
Information provided by (Responsible Party):

August 12, 2011
August 24, 2011
May 15, 2015
January 2007
December 2010   (Final data collection date for primary outcome measure)
Revision Rate [ Time Frame: 4 years ]
Same as current
Complete list of historical versions of study NCT01422564 on ClinicalTrials.gov Archive Site
  • Wear and osteolysis [ Time Frame: 5-15 years ]
  • Harris Hip Score [ Time Frame: immediate post-op, 6 months, 1 year, 2 years, 4 years ]
  • Dislocation Rate [ Time Frame: 4 years ]
  • Complication Rate [ Time Frame: 4 years ]
    All complications
  • Gait Analysis [ Time Frame: 6 months and 1 year post-op ]
    Using the Walkabout portable gait monitor
  • Metal Ions [ Time Frame: 4 years ]
Same as current
Not Provided
Not Provided
Metal on Metal Versus Metal on Highly Crossed Linked Polyethylene Sytem
A Randomized Multicentre Clinical Trial Comparing The Metal on Metal Hip System Versus The Metal on Highly Crossed Linked Polyethylene System
This trial will evaluate the 36mm or greater metal head on metal hip system and compare it to the 32mm or 28mm metal head on polyethylene (liner) hip system in patients receiving a primary cementless total hip replacement.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Osteoarthritis
  • Avascular Necrosis
  • Rheumatoid Arthritis
  • Congenital Dysplasia of the Hip
  • Ankylosing Spondylitis
  • Post-traumatic; Arthrosis
  • Injury of Hip and Thigh
  • Device: Metal on Metal Hip System
    Total hip arthroplasty with a metal on metal component system
    Other Name: Depuy ASR
  • Device: Highly Cross Linked Polyethylene cup System
    Total hip arthroplasty with Highly Cross Linked Polyethylene cup System
    Other Name: Depuy Pinnacle Cup and Marathon liner
  • Active Comparator: Metal on Metal
    Metal on Metal articulation system
    Intervention: Device: Metal on Metal Hip System
  • Active Comparator: HCLPC
    THA using Highly Cross Linked Polyethylene cup System
    Intervention: Device: Highly Cross Linked Polyethylene cup System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2010
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and non-pregnant female subjects 65 years of age or older
  • Subjects undergoing cementless hip arthroplasty. If a press fit metal articulation acetabulum is not possible; the modular cup system will be utilized with screw fixation and a metal head of the greatest diameter deemed appropriate and safe for the patient will be utilized.(At the discretion of the surgeon). The cup in this situation may have a metal or poly articulation. The patient will be followed as an intent to treat (the patient will be evaluated and included in the group as randomized)
  • Subjects with, but not limited to, original diagnoses of osteoarthritis, avascular necrosis, rheumatoid arthritis, congenital dysplasia of the hip, ankylosing spondylitis, posttraumatic arthritis, and traumatic injury to the hip joint.
  • Subjects who are able and willing to understand the conditions of informed consent, to participate in the study according to the protocol for the length of the expected term of follow-up, and to follow their physician's directions.

Exclusion Criteria:

  • Subjects undergoing hip arthroplasty using a cemented femoral component and/or a bipolar prosthesis.
  • Subjects with gross obesity, >45% over ideal body weight for age and height. Refer to Appendix A, Obesity Table.
  • Subjects with active infections.
  • Subjects with malignancy in the area of the involved hip joint.
  • Subjects with a neuromuscular deficit that interferes with the subject's ability to limit weight bearing or places an extreme load on the implant during the healing period.
  • Subjects with a diagnosis of Fibromyalgia
  • Female subjects who are pregnant or may be pregnant.
  • Subjects whom, as judged by the surgeon, are not capable of understanding the informed consent or the requirements of the protocol, or are reasonably unlikely to be compliant with the prescribed postoperative routine and the follow-up evaluation schedule.
  • Subjects who have a known sensitivity to device materials.
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
RL 006
Not Provided
Not Provided
Nova Scotia Health Authority
Nova Scotia Health Authority
University Health Network, Toronto
Principal Investigator: Ross K Leighton, MD Nova Scotia Health Authority
Nova Scotia Health Authority
March 2014

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