UK DRAFFT: A randomised controlled triaof percutaneous fixation with kirschner wires versus volar locking-plate fixation in the treatment of adult patients with a dorsally displaced fracture of the distal radius

Health Technology Assessment

Volumn 19, Issue 17, 2015, Pages 1-124

  Costa, Matthew L ^a   Achten, Juul ^a   Caroline, Plant ^a   Parsons, Nick R ^a   Rangan, Amar ^b   Tubeuf, Sandy ^c   Yu, G ^c   Lamb, Sarah E ^a,d  

^a UNIVERSITY OF WARWICK   (United Kingdom)

^b DURHAM UNIVERSITY   (United Kingdom)

^c UNIVERSITY OF LEEDS   (United Kingdom)

^d UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ALENDRONIC ACID; AMITRIPTYLINE; AMOXICILLIN; AMOXICILLIN PLUS CLAVULANIC ACID; ANTIBIOTIC AGENT; ATENOLOL; ATORVASTATIN; BENDROFLUMETHIAZIDE; BISOPROLOL; CALCIUM CARBONATE; CALCIUM SALT; CITALOPRAM; CLARITHROMYCIN; COCODAMOL; CODEINE; CODYDRAMOL; COLECALCIFEROL; DICLOFENAC; DIHYDROCODEINE; ENALAPRIL MALEATE; ERGOCALCIFEROL; ESOMEPRAZOLE; FERROUS SULFATE; FLUCLOXACILLIN; FUROSEMIDE; IBUPROFEN; LANSOPRAZOLE; LERCANIDIPINE; UNINDEXED DRUG;

ARTICLE; BLOOD VESSEL INJURY; BRACE; COST CONTROL; COST EFFECTIVENESS ANALYSIS; DEBRIDEMENT; DEVICE REMOVAL; DRUG USE; ECONOMIC EVALUATION; EXERCISE; HEALTH CARE COST; HEALTH CARE UTILIZATION; HUMAN; JOINT FUNCTION; KIRSCHNER WIRE; NERVE INJURY; OPERATION DURATION; PERIOPERATIVE PERIOD; PHYSIOTHERAPY; PLASTER CAST; QUALITY ADJUSTED LIFE YEAR; QUALITY OF LIFE; QUESTIONNAIRE; RADIUS FRACTURE; RANDOMIZED CONTROLLED TRIAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REHABILITATION CARE; REOPERATION; RISK BENEFIT ANALYSIS; SPLINT; SURGICAL INFECTION; TECHNICAL AID; TENDON INJURY; TREATMENT OUTCOME; VOLAR PLATE FIXATION; WIRE FIXATION; WRIST; BONE PLATE; BONE WIRE; CLINICAL TRIAL; CONTROLLED STUDY; ECONOMICS; FEMALE; FRACTURES, BONE; MALE; MULTICENTER STUDY; RADIUS; SINGLE BLIND PROCEDURE; UNITED KINGDOM;

BONE PLATES; BONE WIRES; FEMALE; FRACTURES, BONE; GREAT BRITAIN; HUMANS; MALE; QUALITY-ADJUSTED LIFE YEARS; RADIUS; SINGLE-BLIND METHOD;

EID: 84923832702     PISSN: 13665278     EISSN: 20464924     Source Type: Journal    
DOI: 10.3310/hta19170     Document Type: Article

References (50)

1. Barrett JA, Baron JA, Karagas MR, Beach ML. Fracture risk in the U.S. Medicare population. J Clin Epidemiol 1999;52:243–249. http://dx.doi.org/10.1016/S0895-4356(98)00167-X.
2. Chen NC, Jupiter JB. Management of distal radial fractures. J Bone Joint Surg Am 2007;89:2051–62. http://dx.doi.org/10.2106/JBJS.G.00020.
3. Kakarlapudi TK, Santini A, Shahane SA, Douglas D. The cost of treatment of distal radial fractures. Injury 2000;31:229–32. 10.1016/S0020-1383(99)00248-X.
4. Mah ET, Atkinson RN. Percutaneous Kirschner wire stabilisation following closed reduction of Colles’ fractures. J Hand Surg 1992;17:55–62. 10.1016/0266-7681(92)90012-Q.
5. Willis AA, Kutsumi K, Zobitz ME, Cooney WP. Internal fixation of dorsally displaced fractures of the distal part of the radius: a biomechanical analysis of volar plate fracture stability. J Bone Joint Surg Am 2006;88:2411–17. http://dx.doi.org/10.2106/JBJS.E.00946.
6. Arora R, Lutz M, Hennerbichler A, Krappinger D, Espen D, Gabl M. Complications following internal fixation of unstable distal radius fracture with a palmar locking-plate. J Orthop Trauma 2007;21:316. http://dx.doi.org/10.1097/BOT.0b013e318059b993.
7. Handoll HH, Madhok R. From evidence to best practice in the management of fractures of the distal radius in adults: working towards a research agenda. BMC Musculoskelet Disord 2003;4:27. http://dx.doi.org/10.1186/1471-2474-4-27.
8. Willett KM, Gray B, Moran CG, Giannoudis PV, Pallister I. Orthopaedic trauma research priority-setting exercise and development of a research network. Injury 2010;41:763–7. http://dx.doi.org/10.1016/j.injury.2010.03.026.
9. Hull P, Baraza N, Whalley H, Brewster M, Costa M. Dorsally displaced fractures of the distal radius: a study of preferred treatment options among UK trauma and orthopaedic surgeons. Hand Surg 2010;15:185–91. http://dx.doi.org/10.1142/S0218810410004801.
10. Gustilo RB, Anderson JT. Prevention of infection in the treatment of one thousand and twenty-five open fractures of long bones: retrospective and prospective analyses. J Bone Joint Surg Am 1976;58:453–8.
11. Hull P, Baraza N, Gohil M, Whalley H, Mauffrey C, Brewster M, et al. The incidence of dorsally displaced distal radius fractures. EFORT Congress, Nice, France, 29 May–1 June 2008.
12. Ramsay CR, Grant AM, Wallace SA, Garthwaite PH, Monk AF, Russell IT. Statistical assessment of the learning curves of health technologies. Health Technol Assess 2001;5(12). http://dx.doi.org/ 10.3310/hta5120.
13. Downing ND, Karantana A. A revolution in the management of fractures of the distal radius? J Bone Joint Surg Br 2008;90:1271–5. http://dx.doi.org/10.1302/0301-620X.90B10.21293.
14. Zenke Y, Sakai A, Oshige T, Moritani S, Nakamura T. The effect of an associated ulnar styloid fracture on the outcome after fixation of a fracture of the distal radius. J Bone Joint Surg Br 2009;91:102–7. http://dx.doi.org/10.1302/0301-620X.91B1.21026.
15. Berntsen GK, Fønnebø V, Tollan A, Søgaard AJ, Magnus JH. Forearm bone mineral density by age in 7,620 men and women: the Tromsø study, a population-based study. Am J Epidemiol 2001;153:465–73. http://dx.doi.org/10.1093/aje/153.5.465.
16. Court-Brown CM, Caesar B. Epidemiology of adult fractures: a review. Injury 2006;37:691–7. http://dx.doi.org/10.1016/j.injury.2006.04.130.
17. Goldfarb CA, Yin Y, Gilula LA, Fisher AJ, Boyer MI. Wrist fractures: what the clinician wants to know. Radiology 2001;219:11–28. http://dx.doi.org/10.1148/radiology.219.1.r01ap1311.
18. Mann FA, Kang SW, Gilula LA. Normal palmar tilt: is dorsal tilting really normal? J Hand Surg 1992;17:315–17. 10.1016/0266-7681(92)90120-Q.
19. Mackenney PJ, McQueen MM, Elton R. Prediction of instability in distal radial fractures. J Bone Joint Surg Am 2006;88:1944–51. http://dx.doi.org/10.2106/JBJS.D.02520.
20. Steyers CM, Blair WFMeasuring ulnar variance: a comparison of techniquesJ Hand Surg Am1989146071210.1016/0363-5023(89)90175-5.
21. de Vries J, Souer JS, Zurakowski D, Ring D. Measurement of ulnar variance on uncalibrated digital radiographic images. Hand 2010;5:267–72. http://dx.doi.org/10.1007/s11552-009-9249-9.
22. Mignemi ME, Byram IR, Wolfe CC, Fan KH, Koehler EA, Block JJ, et alRadiographic outcomes of volar locked plating for distal radius fracturesJ Hand Surg Am201338408 10.1016/j.jhsa.2012.10.007.
23. MacDermid JC, Turgeon T, Richards RS, Beadle M, Roth JH. Patient rating of wrist pain and disability: a reliable and valid measurement tool. J Orthop Trauma 1998;12:577–86. http://dx.doi.org/10.1097/00005131-199811000-00009.
24. MacDermid JC, Richards RS, Donner A, Bellamy N, Roth JH. Responsiveness of the short form-36, disability of the arm, shoulder, and hand questionnaire, patient-rated wrist evaluation, and physical impairment measurements in evaluating recovery after a distal radius fracture. J Hand Surg Am 2000;25:330–40. http://dx.doi.org/10.1053/jhsu.2000.jhsu25a0330.
25. MacDermid JC, Richards RS, Donner A, Bellamy N, Roth JH. Responsiveness of the short form-36, disability of the arm, shoulder, and hand questionnaire, patient-rated wrist evaluation, and physical impairment measurements in evaluating recovery after a distal radius fracture. J Hand Surg Am 2000;25:330–40. http://dx.doi.org/10.1053/jhsu.2000.jhsu25a0330.
26. Brooks R. EuroQol: the current state of play. Health Policy 1996;37:53–72. 10.1016/0168-8510(96)00822-6.
27. Coole C, Drummond A, Sach TH, Watson PJ. Assessing the feasibility of collecting health care resource use data from general practices for use in an economic evaluation of vocational rehabilitation for back pain. J Eval Clin Pract 2011;17:204–207. 10.1111/j.1365-2753.2010.01364.x.
28. Ridyard CH, Hughes DA. Methods for the collection of resource use data within clinical trials: a systematic review of studies funded by the UK Health Technology Assessment programme. Value Health 2010;13:867–72. http://dx.doi.org/10.1111/j.1524-4733.2010.00788.x.
29. Hull P, Baraza N, Gohil M, Whalley H, Mauffrey C, Brewster M, et al. Volar locking plates versus k-wire fixation of dorsally displaced distal radius fractures: a functional outcome study. J Trauma 2011;70:E125–8. http://dx.doi.org/10.1097/TA.0b013e3181e32714.
30. MacDermid JC, Roth JH, Richards RS. Pain and disability reported in the year following a distal radius fracture: a cohort study. BMC Musculoskelet Disord 2003;4:24. http://dx.doi.org/10.1186/ 1471-2474-4-24.
31. Benson EC, DeCarvalho A, Mikola EA, Veitch JM, Moneim MS. Two potential causes of EPL rupture after distal radius volar plate fixation. Clin Orthop Relat Res 2006;451:218–22. http://dx.doi.org/10.1097/01.blo.0000223998.02765.0d.
32. Brookes ST, Whitley E, Peters TJ, Mulheran PA, Egger M, Davey Smith G. Subgroup analyses in randomised controlled trials: quantifying the risks of false-positives and false-negatives. Health Techol Assess 2001;5(33).
33. National Institute for Health and Care Excellence (NICE). Guide to the Methods of Technology Appraisal. London: NICE; 2008.
34. Curtis L. Unit Costs of Health and Social Care 2012, Canterbury, Kent: Personal Social Services Research Unit; 2012. URL: www.pssru.ac.uk/publication-details.php?id=4378 (accessed October 2013).
35. Rubin DB. Multiple Imputation for Nonresponse in Surveys. New York, NY: John Wiley and Sons; 1987. http://dx.doi.org/10.1002/9780470316696.
36. Little RJA, Rubin DB. Statistical Analysis with Missing Data. 2nd edn. New York, NY: John Wiley and Sons; 2002. http://dx.doi.org/10.1002/9781119013563.
37. Efron B. Better bootstrap confidence-intervals. J Am Stat Assoc 1987;82:171–85. 10.1080/01621459.1987.10478410.
38. Weinstein MC, Siegel JE, Gold MR, Kamlet MS, Russell LBRecommendations of the Panel on Cost-effectiveness in Health and MedicineJAMA19962761253125810.1001/jama.1996.03540150055031.
39. Department of Health (DH). National Schedule of Reference Costs Year 2011–2012 NHS Trusts PCT Combined. London: DH; 2012.
40. The Campbell and Cochrane Economics Methods Group (CCEMG) and the Evidence for Policy and Practice Information and Coordinating Centre (EPPI-Centre). CCEMG – EPPI-Centre Cost Converter. 2013. URL: www.eppi.ioe.ac.uk/costconversion (accessed October 2013).
41. British Medical Association and Royal Pharmaceutical Society of Great Britain. British National Formulary. No. 67, September 2013. London: BMA and RPS; 2013.
42. NHS Business Services Authority, NHS Prescription Services. Electronic Drug Tariff. NHS Business Services Authority; 2013. URL: www.nhsbsa.nhs.uk/924.aspx (accessed October 2013).
43. EuroQol group. What Is EQ-5D? URL: www.euroqol.org/ (accessed 22 November 2013).
44. Office for National Statistics. Statistical Bulletin: Annual Survey of Hours and Earnings, 2012 Provisional Results. London: Office for National Statistics; 2012. URL: www.ons.gov.uk/ons/rel/ashe/ annual-survey-of-hours-and-earnings/2012-provisional-results/stb-ashe-statistical-bulletin-2012.html (accessed 12 December 2012).
45. Dolan P. Modeling valuations for EuroQol health states. Med Care 1997;35:1095–108. http://dx.doi.org/10.1097/00005650-199711000-00002.
46. Cook RJ, Zeng L, Yi GY. Marginal analysis of incomplete longitudinal binary data: a cautionary note on LOCF imputation. Biometrics 2004;60:820–828. http://dx.doi.org/10.1111/j.0006-341X.2004.00234.x.
47. Jansen I, Beunckens C, Molenberghs G, Verbeke G, Mallinckrodt C. Analyzing incomplete discrete logitudinal clinical trial data. Stat Sci 2006;21:52–69. http://dx.doi.org/10.1214/088342305000000322.
48. Gray A, Clarke P, Wolstenholme J, Wordsworth S. Applied Methods of Cost-effectiveness Analysis in Healthcare. Oxford: Oxford University Press; 2010.
49. Beaton DE, van Eerd D, Smith P, van der Velde G, Cullen K, Kennedy CA, et al. Minimal change is sensitive, less specific to recovery: a diagnostic testing approach to interpretability. J Clin Epidemiol 2011;64:487–96. http://dx.doi.org/10.1016/j.jclinepi.2010.07.012.
50. Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Clin Epidemiol 2009;62:499–505. http://dx.doi.org/10.1016/j.jclinepi.2009.01.012.