Sujee Jeyapalina1, J Peter Beck, Roy D Bloebaum, Kent N Bachus. 1. Bone and Joint Research Laboratory, George E. Wahlen Department of Veterans Affairs Medical Center, Veterans Affairs Salt Lake City Health Care System, 500 Foothill Drive, Salt Lake City, UT, 84148, USA.
Abstract
BACKGROUND: Percutaneous osseointegrated prosthetic (POP) devices have been used clinically in Europe for decades. Unfortunately, their introduction into the United States has been delayed, in part due to the lack of data documenting the progression of osseointegration and mechanical stability. QUESTIONS/PURPOSES: We determined the progression of bone ingrowth into porous-coated POP devices and established the interrelationship with mechanical stability. METHODS: After amputation, 64 skeletally mature sheep received a custom porous-coated POP device and were then randomized into five time groups, with subsequent measurement of percentage of bone ingrowth into the available pore spaces (n = 32) and the mechanical pullout force (n = 32). RESULTS: Postimplantation, there was an accelerated progression of bone ingrowth (~48% from 0 to 3 months) producing a mean pullout force of 5066 ± 1543 N. Subsequently, there was a slower but continued progression of bone ingrowth (~23% from 3 to 12 months) culminating with a mean pullout force of 13,485 ± 1855 N at 12 months postimplantation. There was a high linear correlation (R = 0.94) between the bone ingrowth and mechanical pullout stability. CONCLUSIONS: This weightbearing model shows an accelerated progression of bone ingrowth into the porous coating; the amount of ingrowth observed at 3 months after surgery within the porous-coated POP devices was sufficient to generate mechanical stability. CLINICAL RELEVANCE: The data document progression of bone ingrowth into porous-coated POP devices and establish a strong interrelationship between ingrowth and pullout strength. Further human data are needed to validate these findings.
BACKGROUND: Percutaneous osseointegrated prosthetic (POP) devices have been used clinically in Europe for decades. Unfortunately, their introduction into the United States has been delayed, in part due to the lack of data documenting the progression of osseointegration and mechanical stability. QUESTIONS/PURPOSES: We determined the progression of bone ingrowth into porous-coated POP devices and established the interrelationship with mechanical stability. METHODS: After amputation, 64 skeletally mature sheep received a custom porous-coated POP device and were then randomized into five time groups, with subsequent measurement of percentage of bone ingrowth into the available pore spaces (n = 32) and the mechanical pullout force (n = 32). RESULTS: Postimplantation, there was an accelerated progression of bone ingrowth (~48% from 0 to 3 months) producing a mean pullout force of 5066 ± 1543 N. Subsequently, there was a slower but continued progression of bone ingrowth (~23% from 3 to 12 months) culminating with a mean pullout force of 13,485 ± 1855 N at 12 months postimplantation. There was a high linear correlation (R = 0.94) between the bone ingrowth and mechanical pullout stability. CONCLUSIONS: This weightbearing model shows an accelerated progression of bone ingrowth into the porous coating; the amount of ingrowth observed at 3 months after surgery within the porous-coated POP devices was sufficient to generate mechanical stability. CLINICAL RELEVANCE: The data document progression of bone ingrowth into porous-coated POP devices and establish a strong interrelationship between ingrowth and pullout strength. Further human data are needed to validate these findings.
Authors: Brian Mueller Holt; Kent N Bachus; James Peter Beck; Roy Drake Bloebaum; Sujee Jeyapalina Journal: J Biomed Mater Res A Date: 2012-12-27 Impact factor: 4.396
Authors: Sujee Jeyapalina; James Peter Beck; Kent N Bachus; Ornusa Chalayon; Roy D Bloebaum Journal: Clin Orthop Relat Res Date: 2014-10 Impact factor: 4.176
Authors: Carolyn E Taylor; Alex J Drew; Yue Zhang; Yuqing Qiu; Kent N Bachus; K Bo Foreman; Heath B Henninger Journal: PLoS One Date: 2020-08-06 Impact factor: 3.752