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

This study has been terminated.
(Components were recalled by Depuy)
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01422564
First received: August 12, 2011
Last updated: March 6, 2014
Last verified: March 2014

August 12, 2011
March 6, 2014
January 2007
December 2010   (final data collection date for primary outcome measure)
Revision Rate [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01422564 on ClinicalTrials.gov Archive Site
  • Wear and osteolysis [ Time Frame: 5-15 years ] [ Designated as safety issue: No ]
  • Harris Hip Score [ Time Frame: immediate post-op, 6 months, 1 year, 2 years, 4 years ] [ Designated as safety issue: No ]
  • Dislocation Rate [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Complication Rate [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    All complications
  • Gait Analysis [ Time Frame: 6 months and 1 year post-op ] [ Designated as safety issue: No ]
    Using the Walkabout portable gait monitor
  • Metal Ions [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.
 
Terminated
41
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.
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01422564
RL 006
No
Capital District Health Authority, Canada
Capital District Health Authority, Canada
University Health Network, Toronto
Principal Investigator: Ross K Leighton, MD Capital District Health Authority, Canada
Capital District Health Authority, Canada
March 2014

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