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CLINICAL VALIDATION OF A STRUCTURAL POROUS BIOMATERIAL FOR RECONSTRUCTIVE ORTHOPAEDICS



Abstract

There has been a longstanding need for a structural biomaterial that can serve as a bone graft substitute or implant construct and is effective for fixation by bone ingrowth. A porous tantalum material was developed to address these issues. The purpose of this paper and presnetation is to describe the properties and 2 to 5 year clinical results of porous tantalum in various reconstructive orthopaedic procedures.

Porous tantalum has been used to manufacture primary and revision acetabular cups, acetabular augments, tibial and patella implants, patellar augments, structural devices for the treatment of osteonecrosis, and spinal fusion implants. Clinical follow-up includes: 2–5 year clinical and radiographic evaluation of: 414 monoblock cups in primary THA, 36 monoblock cups and 587 revision hemispheres used in revision THR, 16 hips revised with acetabular augments and revision hemispheres; 2 to 4 years for 101 tibial implants used in primary TKR and 69 patellas used in cementless TKR; 2–4 years for 11 patellar augments in salvage TKR, 1–5 years for 53 revision TKRs using knee spacers; 1–4 years for 91 osteone-crosis hip implants; and for 15 cervical fusion cases.

This innovative tantalum implant material with trabecular architecture possesses advantages in stiffness, friction coefficient, porosity, rate and extent of tissue ingrowth, and versatility in manufacturing of structural devices. It has been clinically validated in numerous and diverse reconstructive procedures.

Correspondence should be addressed to Richard Komistek, PhD, International Society for Technology in Arthroplasty, PO Box 6564, Auburn, CA 95604, USA. E-mail: ista@pacbell.net