Case
Study
Simplifying Medical Technology
Case Study: Digital Arthrodesis with Sterile Human Allograft
TenFUSE
™
PIP Allograft
Case Study by Stephen J. Kominsky, DPM, FACFAS, Clinical Professor,
Department of Surgery, George Washington University Medical Center, Washington, DC
CASE STUDY: DIGITAL ARTHRODESIS WITH STERILE HUMAN ALLOGRAFT
Patent Pending • Part No. 20018-A
For more information contact:
Solana Surgical, LLC
6363 Poplar Ave, Suite 312
Memphis, TN 38119
TF: 855-214-1860
V: 901-818-1860 F: 855-540-1861
www.SolanaSurgical.com
www.SolanaSurgical.com
For more information call toll free
855-214-1860
Case study
DIGITAL ARTHRODESIS WITH STERILE HUMAN ALLOGRAFT
FIGURE 1
Pre-op x-ray
INTRODUCTION: A 73 year-old healthy female
presented for a consultation regarding a painful toe.
The pain had progressed to the point where she could
no longer wear shoes comfortably. She endured this
condition for several months before the consultation.
Continuation of non-surgical alternatives were
discussed with the patient which included shoe
modification, padding and oral anti-inflammatory
medications.
A review of the clinical examination and radiographic
(Figure 1) findings revealed a contracture at both the
PIPJ and MTPJ of the second toe on the right foot.
Both joint contractures were primarily in the sagital
plane and were semi-rigid. The author felt that the
best surgical approach would be to perform an
arthrodesis of the PIPJ, with a Weil osteotomy of the
2nd metatarsal. Based on the apex of the deformity,
a correction would need to be made at both joints.
FIGURE 2
TenFUSE PIP, Solana Surgical, Memphis, TN
Historically, arthrodesis of the PIPJ was described as
either a “peg in hole” procedure, or with a Kirschner
wire. The pitfalls of both are well documented
throughout the literature. In the past few years,
several metallic implant devices have been introduced;
each with it’s own set of pitfalls and limitations.
Recently, sterile human bone allograft has been
designed and engineered specifically for this
procedure. Human allograft continues to grow in its
use worldwide. For this particular procedure, the focus
is on bone tissue. One of the major advantages of the
use of human bone allograft is it’s ability to provide
both osteoconductive and osteoinductive activity at the
arthrodesis site, which will differentiate into osteogenic
cells. This process is followed by deep bone
formation. “The goal of using bone allograft is to
initiate a healing response from the host that will
produce new bone at the host-graft interface and
within the porous bone of the graft material”1, 2.
Resorbable materials are not new to the surgical arena.
They have been used in different formats and
formulations for over 30 years. The concept of bone
grafting is also not new and has been published in
2 | Solana Surgical Case Study
FIGURE 3
FIGURE 4
Press fit implantation
TenFUSE PIP with Weil osteotomy
thousands of papers over the years. With the
development of the TenFUSE™ PIP Allograft
(Figure 2) for hammertoe arthrodesis, a new
generation of engineered digital allograft surgery
has begun.
from Solana Surgical, a channel is created in each
phalanx by reaming to the pre-determined depth
based on the laser marking on the reamer. The area
is irrigated and the allograft is inserted. (Figure 3)
There is an option for either a straight or a 10 degree
angled (in flexion) allograft based on the patients
needs and the surgeon’s preference. The allograft is
inserted utilizing forceps only; no other
instrumentation is needed. The ridges on the allograft
enhance the press fit and allow compression at the
fusion site.
This new allograft is safe. Unlike most allografts, the
TenFUSE Allograft is terminally sterilized using a
validated gamma irradiation process at an SAL
(Sterility Assurance Level) of 10-6. This is the same
SAL that the FDA requires for metal and poly
implants.
PROCEDURE: The PIPJ of the 2nd toe is dissected
based on the surgeon’s preference. Once the PIPJ is
exposed, the articular cartilage on the head of the
proximal phalanx and the base of the middle phalanx
is resected using the saw. Minimal amount of bone
should be removed in order to maintain the length of
the toe. The next step is to create the channel for
the placement of the press-fit TenFUSE PIP Allograft.
Utilizing the appropriate size (2.7 or 2.0mm) reamer
CONCLUSION: The use of the sterile TenFUSE PIP
Allograft is quite promising. The early results are
impressive. The allograft maintains the proper
alignment (Figure 4) of the toe in all three planes
while stimulating osteogenic activity. Post-operative
management protocol is immediate weightbearing in
a surgical shoe for 4-6 weeks. Following that period,
the patient may resume most shoes and low impact
activities. Generally, patients should refrain from
running for 8-10 weeks from the surgical date.
The enclosed surgical procedure is furnished for informational purposes only. Each surgeon must evaluate the appropriateness of the device and techniques based on
his or her own medical training, clinical judgement and surgical experience. Proper surgical techniques and procedures are the responsibility of the medical
professional. Solana Surgical cannot recommend a device or procedure that is suitable for all patients. Indications, contraindications, warnings, and precautions are
listed in the implant package insert and should be reviewed by the physician and operating room personnel.
1. JBJS Volume 89.B.5, May 2007. 2. JAPMA Volume 92. #10, November/December 2002.
TenFUSE PIP Allograft | 3
Case study
DIGITAL ARTHRODESIS WITH STERILE HUMAN ALLOGRAFT
FIGURE 1
Pre-op x-ray
INTRODUCTION: A 73 year-old healthy female
presented for a consultation regarding a painful toe.
The pain had progressed to the point where she could
no longer wear shoes comfortably. She endured this
condition for several months before the consultation.
Continuation of non-surgical alternatives were
discussed with the patient which included shoe
modification, padding and oral anti-inflammatory
medications.
A review of the clinical examination and radiographic
(Figure 1) findings revealed a contracture at both the
PIPJ and MTPJ of the second toe on the right foot.
Both joint contractures were primarily in the sagital
plane and were semi-rigid. The author felt that the
best surgical approach would be to perform an
arthrodesis of the PIPJ, with a Weil osteotomy of the
2nd metatarsal. Based on the apex of the deformity,
a correction would need to be made at both joints.
FIGURE 2
TenFUSE PIP, Solana Surgical, Memphis, TN
Historically, arthrodesis of the PIPJ was described as
either a “peg in hole” procedure, or with a Kirschner
wire. The pitfalls of both are well documented
throughout the literature. In the past few years,
several metallic implant devices have been introduced;
each with it’s own set of pitfalls and limitations.
Recently, sterile human bone allograft has been
designed and engineered specifically for this
procedure. Human allograft continues to grow in its
use worldwide. For this particular procedure, the focus
is on bone tissue. One of the major advantages of the
use of human bone allograft is it’s ability to provide
both osteoconductive and osteoinductive activity at the
arthrodesis site, which will differentiate into osteogenic
cells. This process is followed by deep bone
formation. “The goal of using bone allograft is to
initiate a healing response from the host that will
produce new bone at the host-graft interface and
within the porous bone of the graft material”1, 2.
Resorbable materials are not new to the surgical arena.
They have been used in different formats and
formulations for over 30 years. The concept of bone
grafting is also not new and has been published in
2 | Solana Surgical Case Study
FIGURE 3
FIGURE 4
Press-fit implantation
TenFUSE PIP with Weil osteotomy
thousands of papers over the years. With the
development of the TenFUSE™ PIP Allograft
(Figure 2) for hammertoe arthrodesis, a new
generation of engineered digital allograft surgery
has begun.
from Solana Surgical, a channel is created in each
phalanx by reaming to the pre-determined depth
based on the laser marking on the reamer. The area
is irrigated and the allograft is inserted. (Figure 3)
There is an option for either a straight or a 10 degree
angled (in flexion) allograft based on the patients
needs and the surgeon’s preference. The allograft is
inserted utilizing forceps only; No other
instrumentation is needed. The ridges on the allograft
enhance the press-fit and allow compression at the
fusion site.
This new allograft is safe. Unlike most allografts, the
TenFUSE Allograft is terminally sterilized using a
validated gamma irradiation process at an SAL
(Sterility Assurance Level) of 10-6. This is the same
SAL that the FDA requires for metal and poly
implants.
PROCEDURE: The PIPJ of the 2nd toe is dissected
based on the surgeon’s preference. Once the PIPJ is
exposed, the articular cartilage on the head of the
proximal phalanx and the base of the middle phalanx
is resected using the saw. Minimal amount of bone
should be removed in order to maintain the length of
the toe. The next step is to create the channel for
the placement of the press-fit TenFUSE PIP Allograft.
Utilizing the appropriate size (2.7 or 2.0mm) reamer
CONCLUSION: The use of the sterile TenFUSE PIP
Allograft is quite promising. The early results are
impressive. The allograft maintains the proper
alignment (Figure 4) of the toe in all three planes
while stimulating osteogenic activity. Post-operative
management protocol is immediate weightbearing in
a surgical shoe for 4-6 weeks. Following that period,
the patient may resume most shoes and low impact
activities. Generally, patients should refrain from
running for 8-10 weeks from the surgical date.
The enclosed surgical procedure is furnished for informational purposes only. Each surgeon must evaluate the appropriateness of the device and techniques based on
his or her own medical training, clinical judgement and surgical experience. Proper surgical techniques and procedures are the responsibility of the medical
professional. Solana Surgical cannot recommend a device or procedure that is suitable for all patients. Indications, contraindications, warnings, and precautions are
listed in the implant package insert and should be reviewed by the physician and operating room personnel.
1. JBJS Volume 89.B.5, May 2007. 2. JAPMA Volume 92. #10, November/December 2002.
TenFUSE PIP Allograft | 3
Case
Study
Simplifying Medical Technology
Case Study: Digital Arthrodesis with Sterile Human Allograft
TenFUSE
™
PIP Allograft
Case Study by Stephen J. Kominsky, DPM, FACFAS, Clinical Professor,
Department of Surgery, George Washington University Medical Center, Washington, DC
CASE STUDY: DIGITAL ARTHRODESIS WITH STERILE HUMAN ALLOGRAFT
Patent Pending • Part No. 20018-A
For more information contact:
Solana Surgical, LLC
6363 Poplar Ave, Suite 312
Memphis, TN 38119
TF: 855-214-1860
V: 901-818-1860 F: 855-540-1861
www.SolanaSurgical.com
www.SolanaSurgical.com
For more information call toll free
855-214-1860