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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:
ClinicalTrials.gov Identifier:
NCT01422564
First Posted: August 24, 2011
Last Update Posted: May 15, 2015
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.
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Nova Scotia Health Authority
  Purpose
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.

Condition Intervention Phase
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 Device: Highly Cross Linked Polyethylene cup System Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Multicentre Clinical Trial Comparing The Metal on Metal Hip System Versus The Metal on Highly Crossed Linked Polyethylene System

Resource links provided by NLM:


Further study details as provided by Nova Scotia Health Authority:

Primary Outcome Measures:
  • Revision Rate [ Time Frame: 4 years ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 41
Study Start Date: January 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metal on Metal
Metal on Metal articulation system
Device: Metal on Metal Hip System
Total hip arthroplasty with a metal on metal component system
Other Name: Depuy ASR
Active Comparator: HCLPC
THA using Highly Cross Linked Polyethylene cup System
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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): NCT01422564


Sponsors and Collaborators
Nova Scotia Health Authority
University Health Network, Toronto
Investigators
Principal Investigator: Ross K Leighton, MD Nova Scotia Health Authority
  More Information

Responsible Party: Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT01422564     History of Changes
Other Study ID Numbers: RL 006
First Submitted: August 12, 2011
First Posted: August 24, 2011
Last Update Posted: May 15, 2015
Last Verified: March 2014

Additional relevant MeSH terms:
Osteoarthritis
Arthritis, Rheumatoid
Spondylitis
Necrosis
Spondylitis, Ankylosing
Joint Diseases
Hip Injuries
Hip Dislocation, Congenital
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Pathologic Processes
Spondylarthropathies
Spondylarthritis
Ankylosis
Wounds and Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities