Evidence map›Paper›PMID 35891709›Full record

ArticleFrontiers in rehabilitation sciences2022

Temporary Botulinum Immobilization of Residuum Muscles for Facilitation of the Initial Ingrowth of Skin to the Porous

Zachary Bohart, Charles Cassidy, David Merrill, Mario Villani, Rosanna Villani, Leo Cappabianca, Mark Pitkin

Open access · goldAbstract read
In one paragraph

Article in Frontiers in rehabilitation sciences, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.1field-weighted citation impact, top 56% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Zachary BohartDepartment of Orthopaedics and Physical Medicine and Rehabilitation, Tufts University School of Medicine, Boston, MA, United States.
Charles CassidyDepartment of Orthopaedics and Physical Medicine and Rehabilitation, Tufts University School of Medicine, Boston, MA, United States.
David MerrillDaVinci Biomedical Research Products, Lancaster, MA, United States.
Mario VillaniDaVinci Biomedical Research Products, Lancaster, MA, United States.
Rosanna VillaniDaVinci Biomedical Research Products, Lancaster, MA, United States.
Leo CappabiancaDaVinci Biomedical Research Products, Lancaster, MA, United States.
Mark PitkinDepartment of Orthopaedics and Physical Medicine and Rehabilitation, Tufts University School of Medicine, Boston, MA, United States.
Tufts University · US

Funding

Tufts Clinical and Translational Science Institute (Pilot Supplement)UL1TR002544 · NCATS · TUFTS UNIVERSITY BOSTON · PI SELKER, HARRY P. · 2018 to 2022
$50.2M
Validating establishment of functional safety in skin interface with deeply porous transcutaneous pylon for direct skeletal attachment of limb prosthesesR44AR079960 · NIAMS · POLY-ORTH INTERNATIONAL · PI PITKIN, MARK · 2021 to 2022
$1.7M
Large animal study on deeply porous transcutaneous pylon for direct skeletal attachmentR44HD090768 · NICHD · POLY-ORTH INTERNATIONAL · PI PITKIN, MARK · 2016 to 2017
$1.4M
3D-printed Skin and Bone Integrated Pylon (SBIP-3D) for Direct Skeletal Attachment of Limb Prostheses.SB1AR086711 · NIAMS · POLY-ORTH INTERNATIONAL · PI Mark Pitkin · 2025 to 2026
$1.1M
Manufacturing technology for skin integrated composite prosthetic pylonR44HD057492 · NICHD · POLY-ORTH INTERNATIONAL · PI PITKIN, MARK · 2009 to 2010
$750k
Manufacturing technology for skin integrated composite prosthetic pylonR43HD057492 · NICHD · POLY-ORTH INTERNATIONAL · PI PITKIN, MARK · 2007 to 2007
$97k
NCATS NIH HHS UL1 TR002544NIAMS NIH HHS R44 AR079960NIAMS NIH HHS SB1 AR086711NICHD NIH HHS R43 HD057492NICHD NIH HHS R44 HD057492NICHD NIH HHS R44 HD090768
6 · The paper itself

Abstract

Enhancing the technology of bone-anchored limb prosthetics, we present a modified porcine model for developing an infection-free integration between the skin and a percutaneous bone implant. The deeply porous Skin and Bone Integrated Pylon (SBIP) presented an infection-free skin-implant interface both after implantation into the dorsum and after implantation into the residuum after below-knee amputation. However, deep ingrowth of skin into the porous cladding of the SBIP was achieved better in the dorsal procedure, while implantation to the residuum sometimes developed a stoma, probably due to the high mobility of the skin and soft tissues in the pig's thigh. Uncontrolled high skin mobility during the first week after implantation constituted a limitation for the porcine animal model, which we tried to address in the current study. As our previous studies showed that casting of the leg residuum did not sufficiently limit the skin's movement around the implant, we tested a modified protocol of the implantation, which included injection of botulinum toxin into the thigh muscles. During the course of the study, we identified proper botulinum toxin componentry, dosage, and the period after injections to achieve a maximal effect of immobilization of the muscles affecting skin movements. To verify the immobilization, we used kinetic data on the asymmetry of loading during gait with the Strideway System, Tekscan, Inc., Boston, MA, USA. We found that injections in the four muscles of the distal thigh of the left hind leg with MYOBLOC® (rimabotulinumtoxinB; 5,000 units/muscle) were sufficient to provide noticeable immobilization by the fourth week after the procedure. This conclusion was made based on the analysis of the dynamics of asymmetry in vertical ground reactions on the injected (left hind) and uninvolved (right hind) legs during gait over an instrumented walkway.

Indexed as

body-implant interfacebotulinum injectionsdirect skeletal attachmentosseointegrationporcine modelskin immobilization

Identifiers

PMID35891709
PMCPMC9312073
OpenAlexW4214940120

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.