Characteristics of Hylamer polyethylene particles isolated from peri-prosthetic tissues of failed cemented total hip arthroplasties.
Kentaro Iwakiri, Hiroyoshi Iwaki, Akio Kobayashi...
https://pubmed.ncbi.nlm.nih.gov/17806109Actively Recruiting
Led by Osaka Metropolitan University · Updated on 2025-01-20
90
Participants Needed
2
Research Sites
239 weeks
Total Duration
O
Osaka Metropolitan University
Lead Sponsor
M
Mayo Clinic
Collaborating Sponsor
Researchers are evaluating the wear of polyethylene materials used in total hip arthroplasty (THA), focusing on a new vitamin E-containing polyethylene compared to conventional types. This international multicenter study aims to determine whether the vitamin E polyethylene produces fewer wear particles in the body, which could improve long-term outcomes, using a specialized in vivo wear debris analysis method developed by the investigators. The study involves collecting tissue samples from patients undergoing routine revision hip arthroplasty. Three groups of 30 patients each will be compared: those with vitamin E-containing polyethylene, conventional polyethylene without high cross-linking, and conventional polyethylene with high cross-linking. Tissue removed during surgery is processed to isolate polyethylene wear debris, which is then analyzed under a scanning electron microscope to measure the number, size, and shape of the particles. Participants will have clinical data collected, including age, height, weight, time since initial surgery, hip range of motion, and clinical scores such as HOOS Jr, Harris Hip Score, and UCLA activity score. The study measures the polyethylene wear particles' characteristics during revision surgery to compare the materials. This observational study monitors safety and outcomes without additional interventions.
CONDITIONS
Polyethylene Wear Particle Analysis of THA
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Total: 2 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
2
Osaka Metropolitan University
Osaka, Japan, 5458585
Actively Recruiting
K
Kiyoko Kato, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/25712074Yukihide Minoda, Akio Kobayashi, Akira Sakawa...
https://pubmed.ncbi.nlm.nih.gov/18360879