Evaluation of a Novel Degradable Synthetic Biomaterial Patch for Augmentation of Tendon Healing in a Large Animal Model

Abstract Tendon injury is common in sports. The standard of care (SOC) for tendon repair is surgical treatment. However, restored tendons often lack complete strength and functionality, and surgical repair is often unsuccessful. This controlled laboratory study investigates the healing of an Artelon patch (AP)-augmented tendon versus tendon repair alone in a preclinical canine patellar tendon defect model. Full-thickness proximal and distal flap defects were created in the patella tendons of eight purpose-bred research mongrel dogs. Dogs were randomly allocated into either the AP-augmented repair group or the SOC group (N = 8; four knees per group). Outcomes measures included limb function and pain; range of motion (ROM) and ultrasound assessment at 2, 4, and 8 weeks; and measurements of elongation, biomechanical testing, and histology at 8 weeks. Data were compared for statistically significant differences to preoperative measures and between groups (p < 0.05). The AP group had higher limb function scores compared with the SOC group at 2, 4, and 8 weeks, with statistically significant differences observed at 2 weeks (AP: 7.1 ± 1.4, SOC: 5.5 ± 0.4, p < 0.05) and 8 weeks (AP: 9.5 ± 0.7, SOC: 7.0 ± 0.9, p < 0.05). The ROM was significantly higher for the AP group at 4 weeks (AP: 105 degrees ± 4, SOC: 89 degrees ± 5, p < 0.05). Pain scores were statistically significantly lower in the AP group at 4 (AP: 0.6 ± 0.5, SOC: 2.2 ± 0.5) and 8 weeks (p < 0.05 for both comparisons). All animals in the AP group displayed full bridging tissue at week 4, while most animals of the SOC group displayed full bridging by week 8. Minimal tendon elongation was observed in both groups. Significantly more force was required to elongate tendons in the AP group compared with the SOC group (p < 0.05). Animals with AP-augmented tendon repair show an earlier regain of function, earlier regain of range of movement, less postoperative pain, and improved tendon strength when compared with animals treated with tendon repair alone.

[1]  Martin Majewski,et al.  Biologics for tendon repair , 2014, Advanced drug delivery reviews.

[2]  J. Cook,et al.  The Bonar score revisited: region of evaluation significantly influences the standardized assessment of tendon degeneration. , 2014, Journal of science and medicine in sport.

[3]  P. Mouthuy,et al.  Synthetic and degradable patches: an emerging solution for rotator cuff repair , 2013, International journal of experimental pathology.

[4]  T. A. Marberry A Synthetic Reinforcement Patch in Repair of Challenging Two-Tendon Rotator Cuff Tears , 2013 .

[5]  Xinzhi Zhang,et al.  Biomimetic scaffold design for functional and integrative tendon repair. , 2012, Journal of shoulder and elbow surgery.

[6]  Umile Giuseppe Longo,et al.  Scaffolds in Tendon Tissue Engineering , 2011, Stem cells international.

[7]  B. Morrey Augmented Tendon Achilles Repair Using a Tissue Reinforcement Scaffold: A Biomechanical Study , 2012 .

[8]  David Butler,et al.  What we should know before using tissue engineering techniques to repair injured tendons: a developmental biology perspective. , 2011, Tissue engineering. Part B, Reviews.

[9]  D. Robinson,et al.  Treatment of massive rotator-cuff tears with a polyester ligament (Dacron) augmentation: clinical outcome. , 2010, The Journal of bone and joint surgery. British volume.

[10]  Umile Giuseppe Longo,et al.  Tendon augmentation grafts: a systematic review. , 2010, British medical bulletin.

[11]  S. Gumina,et al.  Culture of human rotator cuff cells on orthobiologic support (porcine small intestinal submucosa , 2009, La Chirurgia degli organi di movimento.

[12]  Stephen F Badylak,et al.  Quantification of DNA in biologic scaffold materials. , 2009, The Journal of surgical research.

[13]  G. Balian,et al.  Tendon: biology, biomechanics, repair, growth factors, and evolving treatment options. , 2008, The Journal of hand surgery.

[14]  Kai-Nan An,et al.  Rotator cuff repair using an acellular dermal matrix graft: an in vivo study in a canine model. , 2006, Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association.

[15]  Jiake Xu,et al.  Porcine small intestine submucosa (SIS) is not an acellular collagenous matrix and contains porcine DNA: possible implications in human implantation. , 2005, Journal of biomedical materials research. Part B, Applied biomaterials.

[16]  J. T. Hudson,et al.  Assessing repeatability and validity of a visual analogue scale questionnaire for use in assessing pain and lameness in dogs. , 2004, American journal of veterinary research.

[17]  K. Yamakoshi,et al.  Reconstruction of a defect of the rotator cuff with polytetrafluoroethylene felt graft. Recovery of tensile strength and histocompatibility in an animal model. , 2003, The Journal of bone and joint surgery. British volume.

[18]  P. Ohtonen,et al.  Rerupture and Deep Infection Following Treatment of Total Achilles Tendon Rupture , 2002, The Journal of bone and joint surgery. American volume.

[19]  K. Gisselfält,et al.  Synthesis and properties of degradable poly(urethane urea)s to be used for ligament reconstructions. , 2002, Biomacromolecules.

[20]  A. Lindahl,et al.  Studies of polyurethane urea bands for ACL reconstruction , 2002, Journal of materials science. Materials in medicine.

[21]  A. Natri,et al.  Etiology and pathophysiology of tendon ruptures in sports , 1997, Scandinavian journal of medicine & science in sports.