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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Revision Rate [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
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: NCT01422564

Sponsors and Collaborators
Capital District Health Authority, Canada
University Health Network, Toronto
Investigators
Principal Investigator: Ross K Leighton, MD Capital District Health Authority, Canada
  More Information

No publications provided

Responsible Party: Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01422564     History of Changes
Other Study ID Numbers: RL 006
Study First Received: August 12, 2011
Last Updated: March 6, 2014
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 16, 2014