EXOGEN Ultrasound Bone Healing System for Long Bone Fractures with Non-union or Delayed Healing: a NICE Medical Technology Guidance

Overview

Journal Appl Health Econ Health Policy

Specialty Public Health

Date 2014 Jul 26

PMID 25060830

Citations 26

Authors

Ailish Higgins

Matthew Glover

Yaling Yang

Susan Bayliss

Catherine Meads

Joanne Lord

Affiliations

Soon will be listed here.

Abstract

A routine part of the process for developing National Institute for Health and Care Excellence (NICE) medical technologies guidance is a submission of clinical and economic evidence by the technology manufacturer. The Birmingham and Brunel Consortium External Assessment Centre (EAC; a consortium of the University of Birmingham and Brunel University) independently appraised the submission on the EXOGEN bone healing system for long bone fractures with non-union or delayed healing. This article is an overview of the original evidence submitted, the EAC's findings, and the final NICE guidance issued.

Citing Articles

The Mechanotransduction Signaling Pathways in the Regulation of Osteogenesis.

Liu Z, Wang Q, Zhang J, Qi S, Duan Y, Li C Int J Mol Sci. 2023; 24(18).

PMID: 37762629 PMC: 10532275. DOI: 10.3390/ijms241814326.

Multicenter consensus statements on the use of low-intensity pulsed ultrasound (LIPUS) in Hand Surgery.

Struckmann V, Stolle A, Bocker A, Hagl S, Kneser U, Harhaus L Arch Orthop Trauma Surg. 2023; 143(11):6965-6972.

PMID: 37578657 DOI: 10.1007/s00402-023-05023-5.

Low-Intensity Pulsed Ultrasound Treatment for Non-unions of Long Bone Fractures in a Scottish District General Hospital.

Haller P, Nunag P, Papadopoulos A Cureus. 2023; 15(1):e34159.

PMID: 36843729 PMC: 9949742. DOI: 10.7759/cureus.34159.

Low-Intensity Pulsed Ultrasound Therapy in Patients With Post-traumatic Delayed Union and Non-union.

Pretorius J, Barry M, Fadul A, Murphy C Cureus. 2023; 14(12):e32267.

PMID: 36620791 PMC: 9815886. DOI: 10.7759/cureus.32267.

A Retrospective Study: Is Low-Intensity Pulsed Ultrasound (LIPUS) an Effective Alternate Treatment Option for Non-union?.

Pretorius J, Mohamed Y, Mustafa A, Nemat N, Ellanti P, Hammad Y Cureus. 2022; 14(9):e29230.

PMID: 36277550 PMC: 9578507. DOI: 10.7759/cureus.29230.

References

Withers K, Carolan-Rees G, Dale M . Pipeline™ embolization device for the treatment of complex intracranial aneurysms: a NICE Medical Technology Guidance. Appl Health Econ Health Policy. 2013; 11(1):5-13. PMC: 3563954. DOI: 10.1007/s40258-012-0005-x. View

Ring D, Jupiter J, Sanders R, Quintero J, Santoro V, Ganz R . Complex nonunion of fractures of the femoral shaft treated by wave-plate osteosynthesis. J Bone Joint Surg Br. 1997; 79(2):289-94. DOI: 10.1302/0301-620x.79b2.6886. View

Rutten S, Nolte P, Korstjens C, van Duin M, Klein-Nulend J . Low-intensity pulsed ultrasound increases bone volume, osteoid thickness and mineral apposition rate in the area of fracture healing in patients with a delayed union of the osteotomized fibula. Bone. 2008; 43(2):348-354. DOI: 10.1016/j.bone.2008.04.010. View

Jingushi S, Mizuno K, Matsushita T, Itoman M . Low-intensity pulsed ultrasound treatment for postoperative delayed union or nonunion of long bone fractures. J Orthop Sci. 2007; 12(1):35-41. DOI: 10.1007/s00776-006-1080-3. View

Donaldson L, Reckless I, Scholes S, Mindell J, Shelton N . The epidemiology of fractures in England. J Epidemiol Community Health. 2008; 62(2):174-80. DOI: 10.1136/jech.2006.056622. View

Mayr E, Frankel V, Ruter A . Ultrasound--an alternative healing method for nonunions?. Arch Orthop Trauma Surg. 2000; 120(1-2):1-8. DOI: 10.1007/pl00021234. View

Rubin C, Bolander M, Ryaby J, Hadjiargyrou M . The use of low-intensity ultrasound to accelerate the healing of fractures. J Bone Joint Surg Am. 2001; 83(2):259-70. DOI: 10.2106/00004623-200102000-00015. View

Willits I, Keltie K, Craig J, Sims A . WatchBP Home A for opportunistically detecting atrial fibrillation during diagnosis and monitoring of hypertension: a NICE Medical Technology Guidance. Appl Health Econ Health Policy. 2014; 12(3):255-65. PMC: 4026667. DOI: 10.1007/s40258-014-0096-7. View

Livani B, Belangero W, Medina G, Pimenta C, Zogaib R, Mongon M . Anterior plating as a surgical alternative in the treatment of humeral shaft non-union. Int Orthop. 2009; 34(7):1025-31. PMC: 2989051. DOI: 10.1007/s00264-009-0863-5. View

10.

Higgins A, Glover M, Yang Y, Bayliss S, Meads C, Lord J . EXOGEN ultrasound bone healing system for long bone fractures with non-union or delayed healing: a NICE medical technology guidance. Appl Health Econ Health Policy. 2014; 12(5):477-84. PMC: 4175405. DOI: 10.1007/s40258-014-0117-6. View

11.

Nolte P, van der Krans A, Patka P, Janssen I, Ryaby J, Albers G . Low-intensity pulsed ultrasound in the treatment of nonunions. J Trauma. 2001; 51(4):693-702; discussion 702-3. DOI: 10.1097/00005373-200110000-00012. View

12.

Patil S, Montgomery R . Management of complex tibial and femoral nonunion using the Ilizarov technique, and its cost implications. J Bone Joint Surg Br. 2006; 88(7):928-32. DOI: 10.1302/0301-620X.88B7.17639. View

13.

Kanakaris N, Giannoudis P . The health economics of the treatment of long-bone non-unions. Injury. 2007; 38 Suppl 2:S77-84. DOI: 10.1016/s0020-1383(07)80012-x. View

14.

Gebauer D, Mayr E, Orthner E, Ryaby J . Low-intensity pulsed ultrasound: effects on nonunions. Ultrasound Med Biol. 2005; 31(10):1391-402. DOI: 10.1016/j.ultrasmedbio.2005.06.002. View

15.

White J, Carolan-Rees G . PleurX peritoneal catheter drainage system for vacuum-assisted drainage of treatment-resistant, recurrent malignant ascites: a NICE Medical Technology Guidance. Appl Health Econ Health Policy. 2012; 10(5):299-308. DOI: 10.1007/BF03261864. View

16.

Schofer M, Block J, Aigner J, Schmelz A . Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial. BMC Musculoskelet Disord. 2010; 11:229. PMC: 2958986. DOI: 10.1186/1471-2474-11-229. View

17.

Campbell B, Campbell M . NICE Medical Technologies Guidance: a novel and rigorous methodology to address a new health technology assessment challenge. Appl Health Econ Health Policy. 2012; 10(5):295-7. PMC: 3713955. DOI: 10.2165/11640550-000000000-00000. View