Patients randomized to the Surefire® Infusion System treatment arm will undergo Y-90 glass microsphere embolization with a Surefire catheter.

Patients randomized to the standard end-hole catheter treatment arm will undergo Y-90 glass microsphere embolization with a standard end-hole catheter.

Hepatocellular Carcinoma

Utilization of Surefire® Infusion System for Y-90 glass microsphere embolization

Surefire® Infusion System

Utilization of Standard End-hole catheter for Y-90 glass microsphere embolization

Standard End-hole catheter

Surefire Catheter Versus Standard End-hole Microcatheter: A Pilot Study

Surefire Catheter Versus Standard End-hole Microcatheter in Yttrium-90 Distribution and Tissue Penetration: A Pilot Study

Y-90 distribution and concentration within targeted hepatocellular carcinoma as determined by post embolization PET-CT.

tumor response by Response Evaluation Criteria in Solid Tumors (m-RECIST criteria)

toxicities (per standard labs: Total bilirubin; Aspartate aminotransferase (AST); Alanine aminotransferase (ALT); Albumin; International Normalized Ratio (INR); Creatinine; Alpha Fetoprotein (AFP))

Shannon Kauffman MD

Wright State University

Surefire Medical, Inc.

30 of the 60 patients will be randomized to cemented cup fixation

30 of the 60 patients will be randomized to cementless cup fixation

Osteoarthritis, Hip

Arthropathy of Hip

All patients will preoperatively, 3 months, 1 year, 2 year and 5 year have the hip DXA scanned, answer PROM, X-ray for RSA analysis and wear measurements, and wear accelerometry chip 14 days prior each outward clinic visit for movement analysis.

cup fixation

Avantage® Cup

University Clinic of Hand, Hip and Knee Surgery, Holstebro Hospital

Evaluation of Cemented and Cementless Fixation of Dual-mobility Hip Prosthesis in Elderly Patients With Osteoarthritis

cup migration in the cemented and cementless cups are measures with Radiostereometric Analysis.
The primary endpoint was proximal cup migration (y-axis) at the 2-year follow-up.

measurement af the plastic (polyethylene) are measured with Radiostereometric Analysis.

Dual energy X-ray Absorption (DXA) scans are made to measure to bone mineral density around the prosthesis.

Patient Reported Outcome Measures (PROM) are collected continuously

3-axis accelerometer. Monitor human movements continuously to determine pre and postoperatively movements, mobility and activity for the assessment of functional ability.
The Activity (AX3) device is securely fastened to the patients hip two weeks preoperatively and again two weeks prior to each outward clinic visit at 3 months, 1 yr, 2 yr and 5 yr.

tantalum/vähk

Surefire Catheter Versus Standard End-hole Microcatheter: A Pilot Study

Evaluation of Cemented and Cementless Fixation of Dual-mobility Hip Prosthesis in Elderly Patients With Osteoarthritis

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