- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01422564
Metal on Metal Versus Metal on Highly Crossed Linked Polyethylene Sytem (MOM)
May 14, 2015 updated by: Nova Scotia Health Authority
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Metal on Metal
Metal on Metal articulation system
|
Total hip arthroplasty with a metal on metal component system
Other Names:
|
Active Comparator: HCLPC
THA using Highly Cross Linked Polyethylene cup System
|
Total hip arthroplasty with Highly Cross Linked Polyethylene cup System
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Revision Rate
Time Frame: 4 years
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wear and osteolysis
Time Frame: 5-15 years
|
5-15 years
|
|
Harris Hip Score
Time Frame: immediate post-op, 6 months, 1 year, 2 years, 4 years
|
immediate post-op, 6 months, 1 year, 2 years, 4 years
|
|
Dislocation Rate
Time Frame: 4 years
|
4 years
|
|
Complication Rate
Time Frame: 4 years
|
All complications
|
4 years
|
Gait Analysis
Time Frame: 6 months and 1 year post-op
|
Using the Walkabout portable gait monitor
|
6 months and 1 year post-op
|
Metal Ions
Time Frame: 4 years
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ross K Leighton, MD, Nova Scotia Health Authority
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
August 12, 2011
First Submitted That Met QC Criteria
August 23, 2011
First Posted (Estimate)
August 24, 2011
Study Record Updates
Last Update Posted (Estimate)
May 15, 2015
Last Update Submitted That Met QC Criteria
May 14, 2015
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Congenital Abnormalities
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Spinal Diseases
- Bone Diseases
- Spondylarthropathies
- Spondylarthritis
- Musculoskeletal Abnormalities
- Joint Dislocations
- Hip Dislocation
- Bone Diseases, Infectious
- Ankylosis
- Osteoarthritis
- Necrosis
- Developmental Dysplasia of the Hip
- Hip Dislocation, Congenital
- Spondylitis
- Spondylitis, Ankylosing
Other Study ID Numbers
- RL 006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis
-
Sanford HealthActive, not recruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder Osteoarthritis | Ankle Osteoarthritis | Wrist OsteoarthritisUnited States
-
University of EdinburghHospital for Special Surgery, New YorkRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited Kingdom
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
-
Hospital for Special Surgery, New YorkRoyal Infirmary of EdinburghRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited States, United Kingdom
-
Ottawa Hospital Research InstituteNot yet recruitingKnee Osteoarthritis | Hip Osteoarthritis
-
University Hospital, LilleCompleted
-
Massachusetts General HospitalNewton-Wellesley Hospital; The New England Baptist HospitalCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
Clinical Trials on Metal on Metal Hip System
-
Zimmer BiometBiomet U.K. Ltd.CompletedOsteoarthritis | Rheumatoid Arthritis | Avascular Necrosis | Traumatic ArthritisUnited Kingdom
-
MicroPort Orthopedics Inc.CompletedJoint Pain | Osteoarthritis, Hip | Hip Osteoarthritis | Hip DiseaseUnited States
-
University Hospital, GhentCompletedIndications for a Total Hip ProsthesisBelgium
-
University Hospital, GhentCompleted
-
University Hospital, GhentCompletedIndications for a Total Hip ProsthesisBelgium
-
Zimmer BiometActive, not recruitingOsteoarthritis | Rheumatoid Arthritis | Avascular Necrosis | Inflammatory Arthritis | Post-traumatic ArthritisUnited States
-
Zimmer BiometActive, not recruitingOsteoarthritisFinland, United Kingdom
-
Sahlgrenska University Hospital, SwedenStryker NordicUnknown
-
Zimmer BiometTerminatedOsteoarthritisBosnia and Herzegovina, South Africa