Clinical evaluation of a resorbable wrap-around implant as an alternative to nerve repair: A prospective, assessor-blinded, randomised clinical study of sensory, motor and functional recovery after peripheral nerve repair

Journal of Plastic, Reconstructive and Aesthetic Surgery

Volumn 62, Issue 11, 2009, Pages 1503-1509

  Åberg, Maria ^a   Ljungberg, Christina ^a   Edin, Ellenor ^a   Millqvist, Helena ^a   Nordh, Erik ^a   Theorin, Anna ^a   Terenghi, Giorgio ^a   Wiberg, Mikael ^a  

^a UMEÅ UNIVERSITY   (Sweden)

Author keywords

Biodegradable polymeric nerve conduit; Peripheral nerve repair; Randomised clinical trial

Indexed keywords

POLY(3 HYDROXYBUTYRIC ACID);

ADOLESCENT; ADULT; ARTICLE; CLINICAL ARTICLE; CLINICAL EVALUATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; HUMAN; MALE; MEDIAN NERVE; MOTOR PERFORMANCE; NERVE REGENERATION; NERVE SUTURE; NEUROPSYCHOLOGICAL TEST; PERIPHERAL NERVE INJURY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SENSORIMOTOR FUNCTION; TREATMENT OUTCOME; ULNAR NERVE; WRIST INJURY;

3-HYDROXYBUTYRIC ACID; ABSORBABLE IMPLANTS; ADOLESCENT; ADULT; ELECTROMYOGRAPHY; FEMALE; FOLLOW-UP STUDIES; FOREARM INJURIES; HAND STRENGTH; HUMANS; MALE; MEDIAN NERVE; MEDIAN NEUROPATHY; MICROSURGERY; MIDDLE AGED; MOTOR SKILLS; NERVE REGENERATION; NEUROSURGICAL PROCEDURES; PERIPHERAL NERVES; PROSPECTIVE STUDIES; PROSTHESES AND IMPLANTS; RECONSTRUCTIVE SURGICAL PROCEDURES; RECOVERY OF FUNCTION; SENSATION; SINGLE-BLIND METHOD; TIME FACTORS; ULNAR NEUROPATHIES; WRIST INJURIES; YOUNG ADULT;

EID: 72049096634     PISSN: 17486815     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.bjps.2008.06.041     Document Type: Article

References (51)

1. Lundborg G., and Rosén B. Hand function after nerve repair. Acta Physiol 189 (2007) 207-217
2. Lundborg G. A 25-year perspective of peripheral nerve surgery: Evolving neuroscientific concepts and clinical significance. J Hand Surg [Am] 25 (2000) 391-414
3. Wiberg M., Hazari A., Ljungberg C., et al. Sensory recovery after hand replantation: a clinical, morphological and neurophysiological study in humans. Scand J Plast Reconstr Surg Hand Surg 37 (2003) 163-173
4. McKay Hart A. Sensory neuronal protection and improving regeneration after peripheral nerve injury. Umeå: Umeå University Medical Dissertations; 2003; ISBN 91-7305-370-8.
5. Meiners P.M., Coert J.H., Robinson P.H., et al. Impairment and employment issues after nerve repair in the hand and forearm. Disabil Rehabil 27 (2005) 617-623
6. Dvali L., and Mackinnon S. The role of microsurgery in nerve repair and nerve grafting. Hand Clin 23 (2007) 73-81
7. Ciardelli G., and Chiono V. Materials for peripheral nerve regeneration. Macromol Biosci 6 (2006) 13-26
8. Lohmeyer J., Zimmermann S., Sommer B., et al. Bridging peripheral nerve defects by means of nerve conduits. Chirurg 78 (2007) 142-147
9. Meek M.F., Nicolai J.P., and Robinson P.H. Secondary digital nerve repair in the foot with resorbable p(DLLA-ε-CL) nerve conduits. J Reconstr Microsurg 22 (2006) 149-151
10. Battiston N., Geuna S., Ferrero M., et al. Nerve repair by means of tubulisation: literature review and personal clinical experience comparing biological and synthetic conduits for sensory nerve repair. Microsurgery 25 (2005) 258-267
11. Bertleff M., Meek M., and Nicolai J.P. A prospective clinical evaluation of biodegradable Neurolac nerve guides for sensory nerve repair in the hand. J Hand Surg [Am] 30 (2005) 513-518
12. ® for facial nerve repair. Microsurgery 25 (2005) 268-271
13. Inada Y., Morimoto S., Takakura Y., et al. Regeneration of peripheral nerve gaps with a polyglycolic acid-collagen tube. Neurosurgery 55 (2004) 640-648
14. Lundborg G., Rosen B., Dahlin L., et al. Tubular repair of the median or ulnar nerve in the human forearm: a 5-year follow-up. J Hand Surg [Br] 29 2 (2004) 100-107
15. Cuadros-Romero M. Nerve regeneration using polyglicolic acid as alternative to grafting. J Hand Surg 28 (2003) 17
16. Meek M.F., and Coert J.H. Clinical use of nerve conduits in peripheral nerve repair: review of the literature. J Reconstr Microsurg 18 (2002) 97-109
17. Longo F.M., Hayman E.G., Davis G.E., et al. Neurite-promoting factors and extracellular matrix components accumulating in vivo within nerve regeneration chambers. Brain Res 309 (8-20-1984) 105-117
18. Lundborg G., Longo F.M., and Varon S. Nerve regeneration model and trophic factors in vivo. Brain Res 232 (1-28-1982) 157-161
19. Midha R. Emerging techniques for nerve repair: nerve transfers and nerve guidance tubes. Clin Neurosurg 53 (2006) 185-190
20. Taras J.S., Nanavati V., and Steelman P. Nerve conduits. J Hand Ther 18 (2005) 191-197
21. Strauch B. Use of nerve conduits in peripheral nerve repair. Hand Clin 16 (2000) 123-130
22. Dahlin L., and Lundborg G. Use of tubes in peripheral nerve repair. Neurosurg Clin N Am 12 (2001) 341-352
23. Chen M.B., Zhang F., and Lineaweaver W. Luminal fillers in nerve conduits for peripheral nerve repair. Ann Plast Surg 57 (2006) 462-471
24. Kannan R.Y., Salacinski H.J., Butler P.E., et al. Artificial nerve conduits in peripheral-nerve repair. Biotechnol Appl Biochem 41 (2005) 193-200
25. Evans G.R. Approaches to tissue engineered peripheral nerve. Clin Plast Surg 30 (2003) 559-563
26. Mohanna P.N., Terenghi G., and Wiberg M. Composite PHB-GGF conduit for long nerve gap repair: a long-term evaluation. Scand J Plast Reconstr Surg Hand Surg 39 (2005) 129-137
27. Mohanna P.N., Young R.C., Wiberg M., et al. A composite poly-hydroxybutyrate-glial growth factor conduit for long nerve gap repairs. J Anat 203 (2003) 553-565
28. McKay Hart A., Wiberg M., and Terenghi G. Exogenous leukaemia inhibitory factor anhances nerve regeneration after late secondary repair using a bioartificial nerve conduit. Br J Plast Surg 56 (2003) 444-450
29. Mosahebi A., Wiberg M., and Terenghi G. Addition of fibronectin to alginate matrix improves peripheral nerve regeneration in tissue-engineered conduits. Tissue Eng 9 (2003) 209-218
30. Mosahebi A., Fuller P., Wiberg M., et al. Effect of allogenic Schwann cell transplantation on peripheral nerve regeneration. Exp Neurol 173 (2002) 213-223
31. Novikov L.N., Novikova L.N., Mosahebi A., et al. A novel biodegradable implant for neruonal rescue and regeneration after spinal cord injury. Biomaterials 23 (2002) 3369-3376
32. Young R.C., Wiberg M., Johansson-Rudén, et al. A resorbable PHB conduit for long gap repair in peripheral nerves. Br J Plast Surg 55 (2002) 235-240
33. Hazari A., Wiberg M., Johansson-Rudén G., et al. A resorbable nerve conduit as an alternative to nerve autograft in nerve gap repair. Br J Plast Surg 52 (1999) 653-657
34. Hazari A., Johansson-Rudén G., Junemo-Bostrom K., et al. A new resorbable wrap-around implant as an alternative nerve repair technique. J Hand Surg [Br] 24B 3 (1999) 291-295
35. Ljungberg C., Johansson-Rudén G., Junemo-Bostrom K., et al. Neuronal survival using a resorbable synthetic conduit as an alternative to primary nerve repair. Microsurgery 19 (1999) 259-264
36. Holmes P.A. Biologically produced (R)-3-hydroxyalkanoate polymers and copolymers. In: Bassett D.C. (Ed). Developments in crystalline polymers. 2nd ed. (1988), Elsevier, London
37. Saito T., Tomita K., Kazuhiko J., et al. In vivo and in vitro degradation of Poly(3-hydroxybutyrate) in rat. Biomaterials 12 (1991) 309-312
38. Reusch R.N., Sparrow A.W., and Gardiner J. Transport of poly-beta-hydroxybutyrate in human plasma. Biochim Biophys Acta 1123 (1992) 33-40
39. Malm T., Bowald S., Bylock A., et al. Prevention of postoperative pericardial adhesions by closure of the pericardium with absorbable polymer patches. J Thorac Cardiovasc Surg 104 (1992) 600-607
40. Malm T., Bowald S., Bylock A., et al. Regeneration of pericardial tissue on absorbable polymer patches implanted into the pericardial sac. An immunohistochemical, ultrastructual and biochemical study in the sheep. Scand J Thorac Cardiovasc Surg 26 (1992) 15-21
41. Duvernoy O., Malm T., Ramström J., et al. biodegradable patch used as a pericardial substitute after cardiac surgery: 6- and 24- month evaluation with CT. Thorac Cardiovasc Surg 43 (1995) 271-274
42. An open clinical study on the use of Polyhydroxybutyrate (PHB) to buttress the staple line when excising lung tissue during lung volume reduction surgery. Astra Tech AB, Internal report. 1999.
43. An open, clinical, pilot study of PolyHydroxybutyrate (PHB) in the treatment of chronic leg ulcers. Astra Tech AB, Internal report. 1998.
44. Rosén B., and Lundborg G. A new model instrument for outcome after nerve repair. Hand Clin 19 (2003) 463-470
45. Rosén B., and Lundborg G. A model instrument for the documentation of outcome after nerve repair. J Hand Surg [Am] 25 (2000) 535-554
46. Rosén B. Recovery of sensory and motor function after nerve repair. A rationale for evaluation. J Hand Ther 9 (1996) 315-327
47. Åberg M., Ljungberg C., Edin E., et al. Considerations in evaluating new treatment alternatives following peripheral nerve injuries: a prospective clinical study of methods used to investigate sensory, motor and functional recovery. J Plast Reconstr Aesthet Surg 60 (2007) 103-113
48. Shu S., Ju G., and Fan L. The glucose oxidase-DAB-nickel method in peroxidase histochemistry of the nervous system. Neurosci Lett 85 (1988) 169-171
49. Terenhgi G., Bunker C.B., Liu Y.-F., et al. Image analysis of peptide-immunoreactive nerves in the skin of patients with Raynaud's phenomenon and systemic sclerosis. J Pathol 164 (1991) 245-252
50. Millesi H. Factors affecting the outcome of peripheral nerve surgery. Microsurgery 26 (2006) 295-302
51. Ruijs A.C., Jaquet J.B., Kalmijn S., et al. Median and ulnar nerve injuries: a meta-analysis of predictors of motor and sensory recovery after modern microsurgical nerve repair. Plast Reconstr Surg 116 (2005) 485-496