CLINICAL & SCIENTIFIC
Spartan Medical puts an absolute premium on promoting the best product based on evidence and outcomes. Our advanced medical portfolio is heavily vetted to ensure the ideal treatment pathway is always readily available for our clinical partners and their patients. Below is a list of key published papers and data for review:
TheraSkin Meshed Bioactive Split-thickness Skin Allograft
- Lawrence DiDomenico, DPM, FACFAS; Kenneth J. Emch, DPM, FACFAS; Arnold R. Landsman, DPM; Adam Landsman, DPM, PhD, FACFAS. “A Prospective Comparison of Diabetic Foot Ulcers Treated With Either a Cryopreserved Skin Allograft or a Bioengineered Skin Substitute.” WOUNDS 2011;23(7):184–189.
- Towler, M. Randomized, Prospective, Blinded-Enrollment, Head-To-Head Venous Leg Ulcer Healing Trial Comparing Living, Bioengineered Skin Graft Substitute (Apligraf) with Living Cryopreserved, Human Skin Allograft (TheraSkin). Clin Podiatr Med Surg – (2018)
- The Use of Cryopreserved Human Skin Allograft for the Treatment of Wounds with Exposed Muscle, Tendon, and Bone. Wilson, et al. WOUNDS 2016; 28(4):119-125
- Landsman, AS; et. al. “A Retrospective Clinical Study of 214 Consecutive Patients to Examine the Effectiveness of a Biologically Active Cryopreserved Human Skin Allograft (TheraSkin) on the Treatment of Diabetic Foot Ulcers and Venous leg Ulcers.” Foot & Ankle Spec. 2011;4(1):29-41.
- Apligraf Data: Veves, A, et al, Diabetes Care 24: 290–295, 2001. Steinberg, JS, et al, J Am Pod Med Assoc, 2010, Jan–Feb.; 100(1):73–7.
- Dermagraft data: Marston WA, et al, Dermagraft Diabetic Foot Ulcer Study Group. The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers. Diabetes Care. 2003; 26:1701-1705.
- Apiligraf Data: Falanga V, Sabolinski ML. A bilayered living skin construct (Apligraf®) accelerates complete closure of hard-to-heal venous ulcers. Wound Repair Regen. 1999.Jul-Aug;7(4):201-7.
- Landsman, AS; et. al. “Characterization of a Cryopreserved Split-Thickness Human Skin Allograft – TheraSkin” Advances in Skin & Wound Care; Sept. 2016, Vol. 20, No.9; 399-406.
- Barbul et al., Matched-cohort study comparing bioactive human split-thickness skin allograft plus standard of care to standard of care alone in the treatment of diabetic ulcers: A retrospective analysis across 470 institutions; Wound Repair Regen., 2020 Jan;28(1):81-89. doi: 10.1111/wrr.12767
- Gutner et al., A retrospective matched-cohort study of 3994 lower extremity wounds of multiple etiologies across 644 institutions comparing a bioactive human skin allograft, TheraSkin, plus standard of care, to standard of care alone
Cygnus Amnion/Chorion & Umbilical Cord Patches
- Preserving the Natural Regenerative Potential of Amniotic Membrane; Gaetan J.R. Delcroix, Shabnam Namin, Gianluca D’Ippolito, H. Thomas Temple, Rebecca Marshall.
- A Pilot Study to Evaluate the Safety of Amniotic Membrane Transplantation in Patients with Arthrofibrosis following Total Knee Arthroplasty; Seth A. Jerabek, MD, Kaitlin M. Carroll, BS, Brian Michaels, PA-C, David J. Mayman, MD, Hospital for Special Surgery, NY.
- Orthobiologics in the Foot and Ankle; H. Thomas Temple, MD, Theodore I. Malinin, MD, Foot Ankle Clin N Am 21 (2016) 809–823
- Neil H Riordan, Ben A George, Troy B Chandler and Randall W McKen. “Case report of non‑healing surgical wound treated with dehydrated human amniotic membrane” Journal of Translational Medicine, (2015) 13:242.
- Branski LK, et al., “Amnion in the treatment of pediatric partial-thickness facial burns” Burns (2007).
- E. Bujang-Safawi, A.S. Halim, T.L. Khoo, A.A. Dorai, “Dried irradiated human amniotic membrane as a biological dressing for facial burns—A 7-year case series” Burns (9 July 2009).
- Initial Clinical Experience with the Use of Human Amniotic Membrane Tissue During Repair of Posterior Tibial and Achilles Tendons; Richard M. Jay, DPM, FACFAS, South Jersey Healthcare Vineland.
- Rita Singh, M.P. Chacharkar, “Dried gamma-irradiated amniotic membrane as dressing in burn wound care” Journal of Tissue Viability (2011) 20, 49-54.
Selphyl Leukocyte Poor PRP
- Castillo TN, Pouliot MA, Kim HJ, Dragoo JL. Comparison of growth factor and platelet concentration from commercial PRP separation systems. Am J Sports Med. ePub Nov 4, 2010.
- McCarrel TM., Fortier LA., et. al. Optimization of Leukocyte Concentration in PRP for the Treatment of Tendinopathy. The Journal of Bone & Joint Surgery 2012
- Braun HJ., Dragoo JL., et. al. The Effect of Platelet-Rich Plasma Formulations and Blood Products on Human Synoviocytes. AJSM 2014
- Carlos J. Meheux, M.D., Patrick C. McCulloch ET AL., Efficacy of Intra-articular Platelet-Rich Plasma Injections in Knee Osteoarthritis: A Systematic Review
- Bobin Mi, Guohuio Liu, Wu Zhou ET AL., Platelet rich plasma versus steroid on lateral epicondylitis: meta-analysis of randomized clinical trials; March 2017; 97-104
- Kuan-Yu Lin, M.D., Chia-Chi Yang,. et al., Intra-articular Injection of Platelet-Rich Plasma Is Superior to Hyaluronic Acid or Saline Solution in the Treatment of Mild to Moderate Knee Osteoarthritis: A Randomized, Double-Blind, Triple-Parallel, Placebo-Controlled Clinical Trial; Vol 35, No 1., 2019 pp 106-117
SPARTAN BMA SOLUTIONS
- Scarpone M, et al Marrow Cellution Bone Marrow Aspiration System and Related Concentrations of Stem and Progenitor Cells. White Paper 2015
- McLain R, et al Aspiration of Osteoprogenitor Cells for Augmenting Spinal Fusion: Comparison of Progenitor Cell Concentrations From the Vertebral Body and Iliac Crest. Ded; 87(12)”2655-2661 J Bone Joint Surg Am. 2005
- Hernigou, P el al “Benefits of small volume and small syringe for bone marrow aspirations of mesenchymal stem cells” Int Orthop 2013 Nov; 37 (11):2279-87
- Vishal Hegde MD et al; “Title: A prospective comparison of three approved systems for autologous bone marrow concentration demonstrated non-equivalency in progenitor cell number and concentration.” Journal of Orthopaedic Trauma Publish Ahead of Print
- Dexter TM, et al. J Cell Physiol 91: 335-344, 1977
- Pettine K et al Percutaneous Injection of Autologous Bone Marrow Concentrate Cells Significantly Reduces Lumbar Discogenic Pain Through 12 Months STEM CELLS Jan 2015. Vol 33. issue 1 pg 146-156
- Gan Y et al The clinical use of enriched bone marrow stem cells combined with porous beta-tricalcium phosphate in posterior spinal fusion Biomaterials, 2008, 3973-3982
- Hernigou et al Treatment of Osteonecrosis with autologous bone marrow grafting Clinical Orthopaedics and Realted Research number 405, pp 14-23
- Hernigou P, et al Percutaneous Autologous Bone-Marrow Grafting for Nonunions – Influence of the Number and Concentration of Progenitor Cells The Journal of Bone and Joint Volume 87-A No 7 July 2005
- Muschler GF et al. Spine Fusion Using Cell Matrix Composites Enriched in Bone MarrowDerived Cells; Clinical Ortho.and Related Research; 407, pp. 102–118
- Hernigou P et al., Biologic augmentation for rotator cuff repair with mesenchymal stem cells during arthroscopy improves healing and prevents further tears: a case controlled study; International Orthopaedics: 2014, 38: 1811-1818
- Murrell WD et al., Regenerative treatments to enhance orthopedic surgical outcomes. American Acad of Phy Med and Rehab 2015; S41-S52
- Gobbi et al., One-Step Cartilage Repair with Bone Marrow Aspirate Concentrated Cells and Collagen Matrix in Full-Thickness Knee Cartilage Lesions: Results at 2-Year Follow-up: 2011, Cartilage 2(3) 286–299
- CS. Kasik, et al., Short-Term Outcomes for the Biologic Treatment of Bone Marrow Edema of the Knee Using Bone Marrow Aspirate Concentrate and Injectable Demineralized Bone Matrix; Arthroscopy, Sports Medicine, and Rehabilitation, Vol 1, No 1 (November), 2019: pp e7-e14
LipoPro Adipose-derived Cell Technology
- Freitag et al., Adipose-derived mesenchymal stem cell therapy in the treatment of knee osteoarthritis: a randomized controlled trial, Regenerative Medicine 2019
- Bellei, Migliano, et al., Maximizing non-enzymatic methods for harvesting adipose-derived stem from lipoaspirate: technical considerations and clinical implications for regenerative surgery, Scientific Reports. 2017, Vol 7., 10015
Procenta Allograft Tissue Matrix
- Use of Novel Placental-derived, Conformable Allograft in the Treatment of Non-Healing Chronic Wounds; Ronald L. Dirlam, DPM
- Procenta Binds and Immobilizes Human Platelets for Concise Delivery to Soft Tissue Injuries; Dregalla, R.C., PhD, Lucina BioSciences, LLC
- Nativus, a Novel Tissue Processing Method, Promotes Human Stem Cell Survival, Attachment and Proliferation; Dregalla, R.C., PhD, Lucina BioSciences, LLC
- Procenta®: A Novel Hydrophilic, Bioactive, Human-Derived Allograft Processed Using Nativus®; Dregalla, R.C., PhD, Lucina BioSciences, LLC
- Novel Tissue Processing Technique Conserves Native Soluble Proteins; Dregalla, R.C., PhD, Lucina BioSciences, LLC
ReVIVIFY Flowable Allograft Liquid
- Nyman E., Huss F., Nyman T., Junker J., Kratz G. (2013 Apr), Hyaluronic acid, an important factor in the wound healing properties of amniotic fluid; in vitro studies of re-epithelialization in human skin wounds. J Plast Surg Hand Surg. 47(2):89-92
- Adzick N.S., Lorenz H.P., (1994 Jul) Cells, matrix, growth factors, and the surgeon. The biology of scarless fetal wound repair. Annals of Surgery.; 220(1): 10-18
- Gao X., Devoe L.D., Given K.S., (1994 Aug) Effects of amniotic fluid on proteases; a possible role of amniotic fluid in fetal wound healing. Annals of Plastic Surgery. 33(2): 128-134; discussion 134-135
- Bolat F., Kocamaz F., Kulahcilar Z., Yilmaz A., Topcu A., Ozdemir M., Coskun M. (2013 Dec) Investigation of efficacy of mitomycin-C, sodium hyaluronate and human amniotic fluid in preventing epidural fibrosis and adhesion using a rat laminectomy model. Asian Spine J. 7(4): 253-9
- Cobanglu U., Kutlu N., Karacal N., Kosucu P. (2005 Dec) Effect of human amniotic fluid on bone healing. J Surg Res. 129(2): 283-7
- Ozgenel G., Filiz G., Ozcan M. (2004 Jul) Effects of amniotic fluid on cartilage regeneration from free perichondrial grafts in rabbits. Br J Plast Surg. 57(5): 423-8
- Rosner M., Hipany K., Shanmugasundaram B., Lubec G., Hengstschlager M. (2012 Jun) Amniotic Fluid Stem Cells: Future Perspectives. Stem Cells Int. 2012: 741810
ARTHRODESIS / FUSION
SpartanFuse100 DBM Putty & DBM Crunch
OsteoAmp Allogenic Morphogenic Proteins
- Jeffrey S. Roh, Christopher A Yeung, Justin S Field and R Trigg McClellan. “Allogeneic morphogenetic protein vs. recombinant human bone morphogenetic protein-2 in lumbar interbody fusion procedures: a radiographic and economic analysis” Journal of Orthopedic Surgery and Research 2013, 8:49.
- Justin Field, Christopher Yeung and Jeffrey Roh. “Clinical Evaluation of Allogeneic Growth Factor in Cervical Spine Fusion” J Spine 2014, 3:2.
- Christopher Yeung, Justin Field and Jeffrey Roh. “Clinical Validation of Allogeneic Morphogenetic Protein: Donor Intervariability, Terminal Irradiation and Age of Product is not Clinically Relevant” J Spine 2014, 3:3.
- Osteoamp Case Report: Lateral Lumbar Interbody Fusion; Dr. John O’Toole, Rush University Medical Center.
- Osteoamp Case Report: Posterior Cervical Fusion; Dr. John O’Toole, Rush University Medical Center.
- Osteoamp Case Report: Posterolateral Lumbar Fusion; Dr. Howard An, Rush University Medical Center.
- DeVries JG and Scharer B. “The Use of Allograft Bone Morphogenetic Protein in Foot and Ankle Arthrodesis” HSOA Journal of Orthopedic Research & Physiotherapy 2016, 2:023.
- Osteoamp Case Report: Subtalar Nonunions; Dr. Jason George DeVries and Dr. Brandon M. Scharer, Bay Care Clinic WI.
- Osteoamp Case Report: Ankle Nonunions; Dr. Jason George DeVries, Bay Care Clinic WI.
- Douglas Fredericks, BS, Emily B. Petersen, DVM, Nicole Watson, PhD, Nicole Grosland, PhD, Katherine Gibson-Corley, PhD, Joseph Smucker, MD. “Comparison of Two Synthetic Bone Graft Products in a Rabbit Posterolateral Fusion Model” Iowa Orthopedic Journal; Vol. 36.
- Remi Cavagna, MD, Guy Daculsi, PhD, and Jean-Michel Bouler, PhD. “Macroporous Calcium Phosphate Ceramic: A Prospective Study of 106 Cases in Lumbar Spinal Fusion” Journal of Long-Term Effects of Medical Implants, 9 (4): 403-412 (1999).
- In Vitro and In Vivo Characterization of Signafuse Bioactive Bone Graft; John E. Brunelle, PhD, Scott A. Seaman, PhD, Chase T. Davis, MS, Samson Tom, PhD, MBA, Bioventus Surgical.
- Signafuse Case Report: Adult Scoliosis Revision; Dr. Fred Mo, Georgetown University Hospital.
- Signafuse Case Report: Juvenile Idiopathic Scoliosis; Dr. Fred Mo, Georgetown University Hospital.
- Signafuse: Biomechanical Validation of Fusion in a PLF Rabbit Model; BioStructures.
- Bone Graft Scaffolds: It’s All About the Mineral; BioStructures.
- Signafuse AOP Carrier Dissolution Profile; BioStructures.
- Signafuse: Optimal Bone Graft Remodeling; BioStructures.
- van Dijk LA, Barbieri D, Barrère-de Groot F, Yuan H, Oliver R, Christou C, Walsh WR, de Bruijn JD. “Efficacy of a synthetic calcium phosphate with submicron surface topography as autograft extender in lapine posterolateral spinal fusion.” J Biomed Mater Res B Part B 2019:9999B:9999B:1–11.
- Lukas A. van Dijk, MSc, Florence Barrère-de Groot, PhD, Antoine J.W.P. Rosenberg, MD, PhD, Matthew Pelletier, PhD, Chris Christou, PhD, Joost D. de Bruijn, PhD, and William R. Walsh, PhD, “MagnetOs, Vitoss, and Novabone in a Multi-endpoint Study of Posterolateral Fusion: A True Fusion or Not?” Clin Spine Surg, Vol 00, Number 00, 2020.
- Huipin Yuana, Hugo Fernandes, Pamela Habibovic, Jan de Boer, Ana M. C. Barradas, Ad de Ruiter, William R. Walsh, Clemens A. van Blitterswijk, and Joost D. de Bruijna, “Osteoinductive ceramics as a synthetic alternative to autologous bone grafting” PNAS (2010) Vol. 107, No. 31, 13614-13619.