Download Porcine Soft Tissue Repair Patches

Charles M Zelen, DPM
Nathan Young, DPM
Jordon Z Tacktill, DPM
Charles M. Zelen DPM - Presenter
My disclosure is in the Final AOFAS Mobile App
I have a potential conflict with this presentation due to
This clinical study was funded by Tornier
I am the Primary Investigator
I am on the speakers bureau for Tornier
Nathan Young DPM, – Co-Author
My disclosure is in the final AOFAS Mobile App
I have no potential conflicts with this presentation
Jordon Z Tacktill, DPM – Co-Author
My disclosure is in the Final AOFAS Program App
I have no potential conflicts with this presentation.
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Porcine Soft Tissue Repair Patches have
become more common place to provide
stability and load sharing during the
healing process in tendon and ligament
repars of the foot and ankle.
The ideal patch will serve as a scaffold for
cellular ingrowth that is gradually remodeled
by the body's own tissues.
 Biomechanical testing has shown allogenic and
porcine dermis to be the strongest soft tissue
repair matrices, providing as much as a twofold increase in load to failure compared to
suture alone.
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The Purpose of this Study is to evaluate
the use of a specific
porcine
reconstructive tissue matrix and assess
both safety and efficacy in foot and ankle
reconstruction.
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This is a retrospective single enter central IRB approved clinical
trial
A specific porcine reconstructive tissue matrix was used to
supplement tendon and soft tissue repairs in foot and ankle
surgery
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The Primary objective of this study is to establish that the tissue matrix is
effective in the repair of soft tissue structures of the foot and ankle.
The Secondary objective is to demonstrate the safety of this soft tissue
patch and reconstructive incorporation in 15 consecutive patients without
soft tissue reaction
Patients were evaluated Clinically and with Ultrasound after 24 months
postoperatively
The authors hypothesized that the use of the porcine soft tissue matrix
would lead to clinically successful soft tissue repair, without fluid
formation or soft tissue reaction being observed
Methods
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15 Soft Tissue repairs in
the foot and ankle were
performed using a
porcine soft tissue repair
matrix
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Achilles Tendon Ruptures
Peroneal Repairs
Posterior Tibial Repairs
Patent Population
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Inclusion criteria
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Male or Female
Greater then 18 years of age
Tendon repair with
supplementation with
porcine graft
Exclusions
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Patients with systemic
arthritis or inflammatory
arthritis
History of soft tissue
infection to surgical site
Immunocomprimsed State
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All 15 Soft Tissue Tendon
Repairs healed without
complications

No AE’s or SAE’s noted
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No complications related
to the soft tissue patch
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All 15 patients reported
good -excellent results
25
20
Complications
15
10
No
Complications
5
0
Complications
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Ultrasound
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No Fluid signal noted
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All tendons showed
normal signal to tendon
and soft tissue repair
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No recurrent tears noted
20
15
No Fluid
Signal
10
Fluid
Signal
5
0
Fluid Around Tendon
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A 70-year-old female presented with pain and weakness of the
left lower extremity after sustaining a fall.
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Clinically there was absence of plantarflexion and a positive
Thompson's test
X-rays showed a clear avulsion of the Achilles was identified
Porcine Soft Tissue Matrix was used to reinforce the repair
The above radiographs show the patient intra-operatively and after repair with
soft tissue matrix reinforcement
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A 70-year-old female presented with pain and weakness of
the left lower extremity after sustaining a fall.
Porcine Soft Tissue Matrix was used to reinforce the repair
>24 month follow up illustrates excellent result with no
fluid or abnormality of the Achilles
Ultrasound and Clinical Photograph of Achilles repair greater then 24 months
after surgery illustrating a normal signal , no pathology, re -tear or fluid noted.
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Soft Tissue Repair Matrices
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Clearly provide biomechanical strength to a tendon and soft
tissue repair of the foot and ankle resisting loads nearly twice
as much as a repair without reinforcement
Historically prior xenograft soft tissue patches have been
associated with sometimes extreme soft tissue reactions.
 Intestinal Submucosa grafts
 Equine Pericardial grafts
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Newer Technology and Processing Techniques have allowed
for creation of xenografts that are void of an antigenic response
after human implantation and are regenerative in nature
becoming one with the tendon during the healing process.
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In our small series of patients the porcine grafts
utilized showed universal safety and efficacy in
all the patients studied
 No complications associated with the grafts both subjectively and
objectively confirmed with Ultrasound
 Further studies and larger prospective trials should be considered to
confirm these findings
Foot and Ankle Specialists
should consider soft tissue
repair matrices as a supplement
to tendon and soft tissue repair
in foot and ankle Surgery for
stronger repair and faster return
to activity
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