Scaffolds for tendon and ligament repair: review of the efficacy of commercial products

Driven by market demand, many biological and synthetic scaffolds have been developed during the last 15 years. Both positive and negative results have been reported in clinical applications for tendon and ligament repair. To obtain data for this review, multiple electronic databases were used (e.g., Pubmed and ScienceDirect), as well as the US FDA website and the reference lists from clinical trials, review articles and company reports, in order to identify studies relating to the use of these commercial scaffolds for tendon and ligament repair. The commercial names of each scaffold and the keywords ‘tendon’ and ‘ligament’ were used as the search terms. Initially, 378 articles were identified. Of these, 47 were clinical studies and the others were reviews, editorials, commentaries, animal studies or related to applications other than tendons and ligaments. The outcomes were reviewed in 47 reports (six on Restore™, eight on Graftjacket®, four on Zimmer®, one on TissueMend®, five on Gore-Tex®, six on Lars®, 18 on Leeds–Keio® and one study used both Restore and Graftjacket). The advantages, disadvantages and future perspectives regarding the use of commercial scaffolds for tendon and ligament treatment are discussed. Both biological and synthetic scaffolds can cause adverse events such as noninfectious effusion and synovitis, which result in the failure of surgery. Future improvements should focus on both mechanical properties and biocompatibility. Nanoscaffold manufactured using electrospinning technology may provide great improvement in future practice.

[1]  K. Trieb,et al.  Reconstructing the Extensor Apparatus with a New Polyester Ligament , 2006, Clinical orthopaedics and related research.

[2]  T. Carrel,et al.  The Shelhigh No-React bovine internal mammary artery: a questionable alternative conduit in coronary bypass surgery? , 2008, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[3]  David G Simpson,et al.  Electrospinning of collagen nanofibers. , 2002, Biomacromolecules.

[4]  D. Rimal,et al.  Squamous Cell Carcinoma of the Bladder following PTFE Implantation , 2007, Urologia Internationalis.

[5]  R. Haut,et al.  Tissue-Engineered Rotator Cuff Tendon Using Porcine Small Intestine Submucosa , 2001, The American journal of sports medicine.

[6]  Casey K. Chan,et al.  Enhancement of neurite outgrowth using nano-structured scaffolds coupled with laminin. , 2008, Biomaterials.

[7]  Peter Thomsen,et al.  The inflammatory cell influx and cytokines changes during transition from acute inflammation to fibrous repair around implanted materials , 2006, Journal of biomaterials science. Polymer edition.

[8]  T. Reinsel,et al.  Reconstruction of the digital pulley in the monkey using biologic and nonbiologic materials , 1988, Journal of orthopaedic research : official publication of the Orthopaedic Research Society.

[9]  N. Duval,et al.  A new generation of artificial ligaments in reconstruction of the anterior cruciate ligament. Two-year follow-up of a randomised trial. , 2002, The Journal of bone and joint surgery. British volume.

[10]  K. Fujikawa,et al.  Leeds-Keio artificial ligament: a new concept for the anterior cruciate ligament reconstruction of the knee. , 2001, The Keio journal of medicine.

[11]  T. Fukubayashi,et al.  Follow-up study of Gore-Tex artificial ligament--special emphasis on tunnel osteolysis. , 2000, Journal of long-term effects of medical implants.

[12]  T. Roukis,et al.  Balancing of the transmetatarsal amputation with peroneus brevis to peroneus longus tendon transfer. , 2007, Journal of Foot and Ankle Surgery.

[13]  M. Buyukates,et al.  Giant chest wall tumour invading the abdominal cavity: simultaneous reconstruction of the chest wall and hemidiaphragm. , 2008, Canadian journal of surgery. Journal canadien de chirurgie.

[14]  L. Peterson,et al.  Clinical Experience with the Leeds-Keio Artificial Ligament in Anterior Cruciate Ligament Reconstruction , 1995, The American journal of sports medicine.

[15]  E. Liatsikos,et al.  Gore-tex sling urethral suspension in type III female urinary incontinence: Clinical results and urodynamic changes , 2007, International Urogynecology Journal.

[16]  H. Navsaria,et al.  Human in vivo cellular response to a cross‐linked acellular collagen implant , 2008, The British journal of surgery.

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

[18]  T. Stitik,et al.  Persistent shoulder pain: epidemiology, pathophysiology, and diagnosis. , 2005, American journal of orthopedics.

[19]  M. Pelosi A new nonabsorbable adhesion barrier for myomectomy. , 2002, American journal of surgery.

[20]  S. Badylak,et al.  The use of xenogeneic small intestinal submucosa as a biomaterial for Achilles tendon repair in a dog model. , 1995, Journal of biomedical materials research.

[21]  S Tamai,et al.  Reconstruction of chronic massive rotator cuff tears with synthetic materials. , 1986, Clinical orthopaedics and related research.

[22]  R. Žic,et al.  Adverse Effect of Porcine Collagen Interposition after Trapeziectomy a Comparative Study , 2001, Journal of hand surgery.

[23]  Stephen A. Brigido,et al.  Effective management of major lower extremity wounds using an acellular regenerative tissue matrix: a pilot study. , 2004, Orthopedics.

[24]  D. Hutmacher,et al.  Scaffolds in tissue engineering bone and cartilage. , 2000, Biomaterials.

[25]  George P McCabe,et al.  Extracellular matrix bioscaffolds for orthopaedic applications. A comparative histologic study. , 2006, The Journal of bone and joint surgery. American volume.

[26]  S. A. Ibrahim,et al.  Surgical management of traumatic knee dislocation. , 2008, Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association.

[27]  Daniel K. Lee Achilles tendon repair with acellular tissue graft augmentation in neglected ruptures. , 2007, The Journal of foot and ankle surgery : official publication of the American College of Foot and Ankle Surgeons.

[28]  R Seil,et al.  Age-related prevalence of rotator cuff tears in asymptomatic shoulders. , 1999, Journal of shoulder and elbow surgery.

[29]  J. M. Hunter,et al.  Active tendon implants in flexor tendon reconstruction. , 1988, The Journal of hand surgery.

[30]  J. Barrington,et al.  Bladder augmentation using PelvicolTM implant for intractable overactive bladder syndrome , 2005, International Urogynecology Journal.

[31]  M. Post Rotator cuff repair with carbon filament. A preliminary report of five cases. , 1985, Clinical orthopaedics and related research.

[32]  G. J. Rogers,et al.  Autograft and Leeds-Keio reconstructions of the ovine anterior cruciate ligament. , 1991, Clinical Orthopaedics and Related Research.

[33]  C. Sollerman,et al.  Results from a degradable TMC joint Spacer (Artelon) compared with tendon arthroplasty. , 2005, The Journal of hand surgery.

[34]  Alex P. Jones,et al.  Long-term clinical review (10-20 years) after reconstruction of the anterior cruciate ligament using the Leeds-Keio synthetic ligament. , 2007, Journal of long-term effects of medical implants.

[35]  Michael H. Metcalf,et al.  Surgical technique for xenograft (SIS) augmentation of rotator-cuff repairs , 2002 .

[36]  Brenda K Yantzer,et al.  Comparative in vitro biomechanical evaluation of two soft tissue defect products. , 2007, Journal of biomedical materials research. Part B, Applied biomaterials.

[37]  K. Trieb,et al.  In vivo and in vitro Cellular Ingrowthinto a New Generation of Artificial Ligaments , 2004, European Surgical Research.

[38]  Daniel K. Lee A preliminary study on the effects of acellular tissue graft augmentation in acute Achilles tendon ruptures. , 2008, The Journal of foot and ankle surgery : official publication of the American College of Foot and Ankle Surgeons.

[39]  A. Turner,et al.  Evaluation of a flexible collagen surgical patch for reinforcement of a fascial defect: Experimental study in a sheep model. , 2008, Journal of biomedical materials research. Part B, Applied biomaterials.

[40]  M. Kurosaka,et al.  Reconstruction of the iliofemoral ligament with an artificial ligament for recurrent anterior dislocation of total hip arthroplasty. , 2003, The Journal of arthroplasty.

[41]  W. Walsh,et al.  Mechanical properties of the rotator cuff: response to cyclic loading at varying abduction angles , 2003, Knee Surgery, Sports Traumatology, Arthroscopy.

[42]  A. Weinbroum,et al.  Secondary reconstruction of the extensor mechanism using part of the quadriceps tendon, patellar retinaculum, and Gore-Tex strips after proximal tibial resection. , 2004, The Journal of arthroplasty.

[43]  J. Unger A persistent sinus tract from the vagina to the sacrum after treatment of mesh erosion by partial removal of a GORE-TEX soft tissue patch. , 1999, American journal of obstetrics and gynecology.

[44]  M. Ochi,et al.  Arthroscopic and histologic evaluation of anterior cruciate ligaments reconstructed with the Leeds-Keio ligament. , 1993, Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association.

[45]  L. Rubin,et al.  The use of acellular biologic tissue patches in foot and ankle surgery. , 2005, Clinics in podiatric medicine and surgery.

[46]  S. Badylak,et al.  Small intestinal submucosa: a substrate for in vitro cell growth. , 1998, Journal of biomaterials science. Polymer edition.

[47]  J. Iannotti,et al.  Porcine small intestine submucosa augmentation of surgical repair of chronic two-tendon rotator cuff tears. A randomized, controlled trial. , 2006, The Journal of bone and joint surgery. American volume.

[48]  T. Wredmark,et al.  Patellar tendon or Leeds-Keio graft in the surgical treatment of anterior cruciate ligament ruptures. Intermediate results. , 1993, Clinical orthopaedics and related research.

[49]  P. Beaufils,et al.  Cicatrisation sur tuteur synthtique dans les ruptures rcentes du ligament crois postrieur , 2005 .

[50]  G. Sefton,et al.  Use of Leeds-Keio connective tissue prosthesis (L-K CTP) for reconstruction of deficient extensor mechanism with total knee replacement. , 2005, Knee (Oxford).

[51]  K. Fujikawa,et al.  Anterior cruciate reconstruction with bioactive Leeds-Keio ligament (LKII): preliminary report. , 2006, Journal of long-term effects of medical implants.

[52]  J. Varma,et al.  Porcine dermal collagen graft in abdominal-wall reconstruction. , 2002, British journal of plastic surgery.

[53]  Dennis Bray,et al.  Cell Movements: From Molecules to Motility , 1992 .

[54]  Cyril B. Frank,et al.  Current Concepts Review - The Science of Reconstruction of the Anterior Cruciate Ligament* , 1997 .

[55]  N. Niranjan,et al.  Management of bilateral Achilles tendon rupture associated with ciprofloxacin: a review and case presentation. , 2008, Journal of plastic, reconstructive & aesthetic surgery : JPRAS.

[56]  M. Labbe Arthroscopic technique for patch augmentation of rotator cuff repairs. , 2006, Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association.

[57]  R. Degeorges,et al.  [Reconstruction of acute posterior cruciate ligament tears using a synthetic ligament]. , 2005, Revue de chirurgie orthopedique et reparatrice de l'appareil moteur.

[58]  J. Tibone,et al.  Six-month magnetic resonance imaging follow-up of large and massive rotator cuff repairs reinforced with porcine small intestinal submucosa. , 2004, Journal of shoulder and elbow surgery.

[59]  Stephen A. Brigido,et al.  Reconstruction of the Diseased Achilles Tendon Using an Acellular Human Dermal Graft Followed by Early Mobilization-A Preliminary Series , 2007 .

[60]  A. Hirshberg,et al.  Early Definitive Closure of the Open Abdomen: A Quiet Revolution , 2005, Scandinavian journal of surgery : SJS : official organ for the Finnish Surgical Society and the Scandinavian Surgical Society.

[61]  J. Webster Encyclopedia of Medical Devices and Instrumentation , 1988 .

[62]  G. Cerulli,et al.  Reconstruction of the anterior cruciate ligament: dynamic strain evaluation of the graft , 2007, Knee Surgery, Sports Traumatology, Arthroscopy.

[63]  M. Bigoni,et al.  Long-term results of the Leeds-Keio anterior cruciate ligament reconstruction , 2005, Knee Surgery, Sports Traumatology, Arthroscopy.

[64]  M. Herbert,et al.  Tendon augmentation grafts: biomechanical failure loads and failure patterns. , 2006, Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association.

[65]  Michael S Lee GraftJacket augmentation of chronic Achilles tendon ruptures. , 2004, Orthopedics.

[66]  R. Guidoin,et al.  Analysis of retrieved polymer fiber based replacements for the ACL. , 2000, Biomaterials.

[67]  M. Macnicol,et al.  10-16 year results of Leeds-Keio anterior cruciate ligament reconstruction. , 2004, The Knee.

[68]  Robert D Moore,et al.  Rectovaginal Fistula Repair Using a Porcine Dermal Graft , 2004, Obstetrics and gynecology.

[69]  S. Rehart,et al.  Empathie und fachliche Kompetenz , 2004, Der Orthopäde.

[70]  Smith Rb,et al.  The Leeds-Keio prosthesis in chronic anterior cruciate deficiency. , 1992 .

[71]  C. Sundaram,et al.  Laparoscopic sacrocolpopexy for the correction of vaginal vault prolapse. , 2004, Journal of endourology.

[72]  S. Snyder,et al.  Arthroscopic replacement of massive, irreparable rotator cuff tears using a GraftJacket allograft: technique and preliminary results. , 2008, Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association.

[73]  Sachin P Badhe,et al.  An assessment of porcine dermal xenograft as an augmentation graft in the treatment of extensive rotator cuff tears. , 2008, Journal of shoulder and elbow surgery.

[74]  H. Sugiura,et al.  Ultrastructural study of the extra-articular Leeds-Keio ligament prosthesis , 2005, Journal of Clinical Pathology.

[75]  Kamura,et al.  Augmentation with a Gore-Tex patch for repair of large rotator cuff tears that cannot be sutured , 2022 .

[76]  G. Beaupré,et al.  Mechanical properties of the human achilles tendon. , 2001, Clinical biomechanics.

[77]  G. Murrell,et al.  Early Inflammatory Reaction after Rotator Cuff Repair with a Porcine Small Intestine Submucosal Implant , 2005, The American journal of sports medicine.

[78]  H. Sugiura,et al.  Histological evaluation of medial patellofemoral ligament reconstructed using the Leeds-Keio ligament prosthesis. , 2005, Biomaterials.

[79]  N. Dalén,et al.  Gross osteolytic tibia tunnel widening with the use of Gore-Tex anterior cruciate ligament prosthesis , 2005, Acta Orthopaedica.

[80]  S. Snyder,et al.  Arthroscopic total rotator cuff replacement with an acellular human dermal allograft matrix , 2007 .

[81]  Stephen A. Brigido,et al.  The use of an acellular dermal regenerative tissue matrix in the treatment of lower extremity wounds: a prospective 16‐week pilot study , 2006, International wound journal.

[82]  M. F. Macnicol,et al.  Early results of the Leeds-Keio anterior cruciate ligament replacement. , 1991, The Journal of bone and joint surgery. British volume.

[83]  A. Wilson,et al.  Current concepts in the management of tendon disorders. , 2006, Rheumatology.

[84]  M. Curtis,et al.  Early complications from the use of porcine dermal collagen implants (Permacol) as bridging constructs in the repair of massive rotator cuff tears. A report of 4 cases. , 2007, Acta orthopaedica Belgica.

[85]  C. Peters,et al.  Early aseptic loosening of a total knee arthroplasty due to Gore-Tex particle-induced osteolysis. , 2006, The Journal of arthroplasty.

[86]  Sumant G. Krishnan,et al.  Use of Graft Jacket as an Augmentation for Massive Rotator Cuff Tears , 2007 .

[87]  A. R. Baker,et al.  Commercial extracellular matrix scaffolds for rotator cuff tendon repair. Biomechanical, biochemical, and cellular properties. , 2006, The Journal of bone and joint surgery. American volume.

[88]  T. Wredmark,et al.  Five-year results of anterior cruciate ligament reconstruction with the Stryker Dacron high-strength ligament , 2005, Knee Surgery, Sports Traumatology, Arthroscopy.

[89]  C. Winslow,et al.  Use of allogenic dermis for radial forearm free flap donor site coverage. , 2002, The Journal of otolaryngology.

[90]  G. W. Johnson,et al.  Treatment of lateral epicondylitis. , 1991, The American journal of occupational therapy : official publication of the American Occupational Therapy Association.

[91]  J. Fernandes,et al.  Knee dislocations: experience at the Hôpital du Sacré-Coeur de Montréal. , 2004, Canadian journal of surgery. Journal canadien de chirurgie.

[92]  Takashi Nakamura,et al.  A retrospective review of bone tunnel enlargement after anterior cruciate ligament reconstruction with hamstring tendons fixed with a metal round cannulated interference screw in the femur. , 2006, Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association.

[93]  S. Ishii,et al.  Augmented subscapularis muscle transposition for rotator cuff repair during shoulder arthroplasty in patients with rheumatoid arthritis. , 2006, Journal of shoulder and elbow surgery.

[94]  Freddie H. Fu,et al.  Anatomic double-bundle anterior cruciate ligament reconstruction revision surgery. , 2007, Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association.

[95]  E. Rodriguez,et al.  Human acellular dermal matrix for repair of abdominal wall defects: review of clinical experience and experimental data. , 2005, Journal of long-term effects of medical implants.

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

[97]  Lavoie,et al.  Patient satisfaction needs as related to knee stability and objective findings after ACL reconstruction using the LARS artificial ligament. , 2000, The Knee.

[98]  C Milgrom,et al.  Rotator-cuff changes in asymptomatic adults. The effect of age, hand dominance and gender. , 1995, The Journal of bone and joint surgery. British volume.

[99]  A. Smith,et al.  Analysis of the Leeds-Keio ligament for extensor mechanism repair: favourable mechanical and functional outcome. , 2003, The Knee.

[100]  G. Benfatto,et al.  La riparazione dell’ernia ombelicale nella donna in postmenopausa , 2007 .

[101]  G. Murrell,et al.  Restore orthobiologic implant: not recommended for augmentation of rotator cuff repairs. , 2007, The Journal of bone and joint surgery. American volume.

[102]  R. Williams,et al.  Long-term local effects of carbon fibre in the knee. , 2004, The Knee.

[103]  R. Seldes,et al.  Arthroscopic insertion of a biologic rotator cuff tissue augmentation after rotator cuff repair. , 2006, Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association.

[104]  Nomura,et al.  A mid-term follow-up of medial patellofemoral ligament reconstruction using an artificial ligament for recurrent patellar dislocation. , 2000, The Knee.

[105]  N. Yousif,et al.  The midface sling: a new technique to rejuvenate the midface. , 2002, Plastic and reconstructive surgery.

[106]  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.