Metal on Metal Versus Metal on Highly Crossed Linked Polyethylene Sytem (MOM)
This study has been terminated.
(Components were recalled by Depuy)
Sponsor:
Capital District Health Authority, Canada
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, 2012
Last verified: May 2007
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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:
Genetics Home Reference related topics:
ankylosing spondylitis
MedlinePlus related topics:
Ankylosing Spondylitis
Hip Injuries and Disorders
Joint Disorders
Osteoarthritis
Rheumatoid Arthritis
Drug Information available for:
Polyethylene
U.S. FDA Resources
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 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, Contract |
| Study First Received: | August 12, 2011 |
| Last Updated: | March 6, 2012 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Hip Dislocation, Congenital Joint Diseases Osteoarthritis Necrosis Osteonecrosis Spondylitis Spondylitis, Ankylosing Hip Injuries Congenital Abnormalities Musculoskeletal Diseases Rheumatic Diseases |
Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Musculoskeletal Abnormalities Pathologic Processes Bone Diseases Bone Diseases, Infectious Infection Spinal Diseases Spondylarthropathies Spondylarthritis Ankylosis Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013