A Comparison of Large Diameter Metal Heads vs. Small Diameter Metal Heads vs. Dual Mobility Total Hip Replacements
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 13-002050
NCT ID: NCT02049892
Sponsor Protocol Number: 13-002050
About this study
Does having a large diameter metal on polyethylene total hip replacement increase metal ion release? Larger metal heads are thought to have increased torsional forces on the trunion which would like release more metal ions. Increased metal ion levels have been associated with adverse local tissue reactions. Are there any differences comparing these groups to a dual mobility type total hip replacement.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- One total hip replacement, either a large metal head (>40) or a small metal head (<30) on a polyethylene bearing surface.
- 2 to 5 years s/p surgery minimum. No symptoms
Exclusion Criteria:
- Any other bearing surface besides metal on poly, no other joint replacements, symptomatic
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Robert Trousdale, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available