Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2017

Open Access 01-12-2017 | Study protocol

Comparison of volar-flexion, ulnar-deviation and functional position cast immobilization in the non-operative treatment of distal radius fracture in elderly patients: a pragmatic randomized controlled trial study protocol

Authors: Lauri Raittio, Antti Launonen, Teemu Hevonkorpi, Toni Luokkala, Juha Kukkonen, Aleksi Reito, Bakir Sumrein, Minna Laitinen, Ville M. Mattila

Published in: BMC Musculoskeletal Disorders | Issue 1/2017

Login to get access

Abstract

Background

Distal radius fractures (DRFs) are the second most common fractures, after hip fractures, seen in clinical practice. The high incidence of low-energy trauma DRFs in elderly patients raises questions about the best treatment method in terms of function, pain, and quality of life. Although the majority of these fractures are treated non-operatively with cast immobilization, valid scientific evidence of the optimal cast immobilization is lacking. In addition, several publications, including Cochrane review have outlined the need for more evidence to determine the most appropriate method of cast immobilization.

Methods

This study is a pragmatic, prospective, randomized, multi-centre trial. The trial is designed to compare two widely used cast positions (volar flexion-ulnar deviation position and functional position) for the non-operative treatment of DRF in patients over 64 years of age. The main hypothesis of the trial is that function position yields corresponding functional outcome, pain relief and quality of life when compared to the volar flexion-ulnar deviation position. The primary outcome measure is Patient Rated Wrist Evaluation (PRWE) score and the secondary outcome measures will be the Disabilities of the Arm, Shoulder and Hand (DASH) score, Visual Analogue Scale (VAS), 15-dimensional (15D) value and rate of surgical interventions. The results of the trial will be analysed after 1 and 2-years.

Discussion

This publication presents a prospective, pragmatic, randomized, national multi-centre trial study protocol. It provides details of patient flow, randomization, follow-up and methods of analysis of the material as well as publication plan.

Trial registration

ClinicalTrials.​gov identifier: NCT02894983 22 August 2016.
Appendix
Available only for authorised users
Literature
1.
2.
O’neill T, Cooper C, Finn J, Lunt M, Purdie D, Reid D, Rowe R, Woolf A, Wallace W. Incidence of distal forearm fracture in British men and women. Osteoporosis Int. 2001;12(7):555–8.CrossRef
3.
Solgaard S, Petersen VS. Epidemiology of distal radius fractures. Acta Orthop Scand. 1985;56(5):391–3.CrossRefPubMed
4.
Flinkkilä T, Sirniö K, Hippi M, Hartonen S, Ruuhela R, Ohtonen P, Hyvönen P, Leppilahti J. Epidemiology and seasonal variation of distal radius fractures in Oulu, Finland. Osteoporosis Int. 2011;22(8):2307–12.CrossRef
5.
Bentohami A, Bosma J, Akkersdijk GJ, van Dijkman B, Goslings JC, Schep NW. Incidence and characteristics of distal radial fractures in an urban population in The Netherlands. Eur J Trauma Emerg Surg. 2014;40(3):357–61.PubMed
6.
Mellstrand-Navarro C, Pettersson HJ, Tornqvist H, Ponzer S. The operative treatment of fractures of the distal radius is increasing: results from a nationwide Swedish study. Bone Joint J. 2014;96-B(7):963–9.CrossRefPubMed
7.
Sigurdardottir K, Halldorsson S, Robertsson J. Epidemiology and treatment of distal radius fractures in Reykjavik, Iceland, in 2004. Comparison with an Icelandic study from 1985. Acta Orthop. 2011;82(4):494–8.CrossRefPubMedPubMedCentral
8.
Wilcke MK, Hammarberg H, Adolphson PY. Epidemiology and changed surgical treatment methods for fractures of the distal radius: a registry analysis of 42,583 patients in Stockholm County, Sweden, 2004–2010. Acta Orthop. 2013;84(3):292–6.CrossRefPubMedPubMedCentral
9.
Schneppendahl J, Windolf J, Kaufmann RA. Distal radius fractures: current concepts. J Hand Surg. 2012;37(8):1718–25.CrossRef
10.
Blatter G, Papp P, Magerl F. A comparison of 2 methods of plastic cast fixation in treatment of loco classico radius fracture. A prospective, randomized study. Unfallchirurg. 1994;97(10):534–40.PubMed
11.
Sarmiento A, Zagorski JB, Sinclair WF. Functional bracing of Colles' fractures: a prospective study of immobilization in supination vs. pronation. Clin Orthop. 1980;146:175–83.
12.
Wahlström O. Treatment of Colles' fracture: a prospective comparison of three different positions of immobilization. Acta Orthop Scand. 1982;53(2):225–8.CrossRefPubMed
13.
Wilson C, Venner RM. Colles' Fracture. Immobilisation in pronation or supination? J R Coll Surg Edinb. 1984;29(2):109–11.PubMed
14.
Gupta A. The treatment of Colles' fracture. Immobilisation with the wrist dorsiflexed. J Bone Joint Surg Br. 1991;73(2):312–5.PubMed
15.
van der Linden W, Ericson R. Colles' Fracture. How should its displacement be measured and how should it be immobilized? J Bone Joint Surg Am. 1981;63(8):1285–8.CrossRefPubMed
16.
Cotton F. Dislocations and Joint Fractures. 1st ed. Philadelphia and London: W.B. Saunders Company; 1910.
17.
Charnley J. The Closed Treatment of Common Fractures. Baltimore: Edinburgh, McLagan and Cumming, Ltd.; The Williams and Wilkins Company; 1950.
18.
Agee JM. External fixation. Technical advances based upon multiplanar ligamentotaxis. Orthop Clin North Am. 1993;24(2):265–74.PubMed
19.
Agee JM. Application of multiplanar ligamentotaxis to external fixation of distal radius fractures. Iowa Orthop J. 1994;14:31–7.PubMedPubMedCentral
20.
Gelberman RH, Szabo RM, Mortensen WW. Carpal tunnel pressures and wrist position in patients with colles' fractures. J Trauma Acute Care Surg. 1984;24(8):747–9.CrossRef
21.
Dyer G, Lozano-Calderon S, Gannon C, Baratz M, Ring D. Predictors of acute carpal tunnel syndrome associated with fracture of the distal radius. J Hand Surg. 2008;33(8):1309–13.CrossRef
22.
McKay SD, MacDermid JC, Roth JH, Richards RS. Assessment of complications of distal radius fractures and development of a complication checklist. J Hand Surg. 2001;26(5):916–22.CrossRef
23.
Vainiola T, Pettilä V, Roine RP, Räsänen P, Rissanen AM, Sintonen H. Comparison of two utility instruments, the EQ-5D and the 15D, in the critical care setting. Intensive Care Med. 2010;36(12):2090–3.CrossRefPubMedPubMedCentral
24.
Sintonen H. The 15D instrument of health-related quality of life: properties and applications. Ann Med. 2001;33(5):328–36.CrossRefPubMed
25.
Jiang Y, Sanchez-Santos MT, Judge AD, Murray DW, Arden NK. Predictors of patient-reported pain and functional outcomes over 10 years after primary Total knee Arthroplasty: a prospective cohort study. J Arthroplast. 2016;
26.
Sullivan MJ, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychol Assess. 1995;7(4):524.CrossRef
27.
Teunis T, Bot AG, Thornton ER, Ring D. Catastrophic thinking is associated with finger stiffness after distal radius fracture surgery. J Orthop Trauma. 2015;29(10):e414–20.CrossRefPubMed
28.
Handoll H, Madhok R. Conservative interventions for treating distal radial fractures in adults. Cochrane Database Syst Rev. 2003;2(2):CD000314.
29.
Young BT, Rayan GM. Outcome following nonoperative treatment of displaced distal radius fractures in low-demand patients older than 60 years. J Hand Surg. 2000;25(1):19–28.CrossRef
30.
Arora R, Lutz M, Deml C, Krappinger D, Haug L, Gabl M. A prospective randomized trial comparing nonoperative treatment with volar locking plate fixation for displaced and unstable distal radial fractures in patients sixty-five years of age and older. J Bone Joint Surg Am. 2011;93(23):2146–53.CrossRefPubMed
31.
Grewal R, MacDermid JC. The risk of adverse outcomes in extra-articular distal radius fractures is increased with malalignment in patients of all ages but mitigated in older patients. J Hand Surg. 2007;32(7):962–70.CrossRef
32.
Azzopardi T, Ehrendorfer S, Coulton T, Abela M. Unstable extra-articular fractures of the distal radius: a prospective, randomised study of immobilisation in a cast versus supplementary percutaneous pinning. J Bone Joint Surg Br. 2005;87(6):837–40.CrossRefPubMed
33.
Abbaszadegan H, Jonsson U. External fixation or plaster cast for severely displaced colles' fractures?: prospective 1-year study of 46 patients. Acta Orthop Scand. 1990;61(6):528–30.CrossRefPubMed
34.
McQueen M, Hajducka C. Redisplaced unstable fractures of the distal radius: a prospecitve randomised comparison of four methods of treatment. J Bone Joint Surg Br. 1996;78(3):404–9.PubMed
35.
Stein H, Volpin G, Horesh Z, Hoerer D. Cast or external fixation for fracture of the distal radius: a prospective study of 126 cases. Acta Orthop Scand. 1990;61(5):453–6.CrossRefPubMed
36.
Lintonl SJ, Nicholasl MK, MacDonaldl S, Boersmal K, Bergboml S, Maherl C, Refshaugel K. The role of depression and catastrophizing in musculoskeletal pain. Eur J Pain. 2011;15(4):416–22.CrossRef
37.
Jelicic M, Kempen G. Do psychological factors influence pain following a fracture of the extremities? Injury. 1999;30(5):323–5.CrossRefPubMed
38.
Das De S, Vranceanu AM, Ring DC. Contribution of kinesophobia and catastrophic thinking to upper-extremity-specific disability. J Bone Joint Surg Am. 2013;95(1):76–81.CrossRefPubMed
39.
Roh YH, Lee BK, Noh JH, Oh JH, Gong HS, Baek GH. Effect of anxiety and catastrophic pain ideation on early recovery after surgery for distal radius fractures. J Hand Surg. 2014;39(11):2258–2264. e2.CrossRef
40.
Rivest K, Côté JN, Dumas J, Sterling M, De Serres SJ. Relationships between pain thresholds, catastrophizing and gender in acute whiplash injury. Man Ther. 2010;15(2):154–9.CrossRefPubMed
41.
Edwards RR, Bingham CO, Bathon J, Haythornthwaite JA. Catastrophizing and pain in arthritis, fibromyalgia, and other rheumatic diseases. Arthritis Care Res (Hoboken). 2006;55(2):325–32.CrossRef
42.
Söderlund A, Åsenlöf P. The mediating role of self-efficacy expectations and fear of movement and (re) injury beliefs in two samples of acute pain. Disabil Rehabil. 2010;32(25):2118–26.CrossRefPubMed
43.
Batra S, Gupta A. The effect of fracture-related factors on the functional outcome at 1 year in distal radius fractures. Injury. 2002;33(6):499–502.CrossRefPubMed
44.
Anzarut A, Johnson JA, Rowe BH, Lambert RG, Blitz S, Majumdar SR. Radiologic and patient-reported functional outcomes in an elderly cohort with conservatively treated distal radius fractures. J Hand Surg. 2004;29(6):1121–7.CrossRef
45.
Walenkamp MM, de Muinck KR, Goslings JC, Vos LM, Rosenwasser MP, Schep NW. The minimum clinically important difference of the patient-rated wrist evaluation score for patients with distal radius fractures. Clin Orthop Relat Res®. 2015;473(10):3235–41.CrossRef
Metadata
Title
Comparison of volar-flexion, ulnar-deviation and functional position cast immobilization in the non-operative treatment of distal radius fracture in elderly patients: a pragmatic randomized controlled trial study protocol
Authors
Lauri Raittio
Antti Launonen
Teemu Hevonkorpi
Toni Luokkala
Juha Kukkonen
Aleksi Reito
Bakir Sumrein
Minna Laitinen
Ville M. Mattila
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2017
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-017-1759-y

Other articles of this Issue 1/2017

BMC Musculoskeletal Disorders 1/2017 Go to the issue

Research article

A cross-sectional study on sarcopenia using different methods: reference values for healthy Saudi young men

Research article

Compliance and persistence with oral bisphosphonates for the treatment of osteoporosis in female patients with rheumatoid arthritis

Research article

Association between antibodies to carbamylated proteins and subclinical atherosclerosis in rheumatoid arthritis patients

Research article

Clavicle fractures: epidemiology, classification and treatment of 2 422 fractures in the Swedish Fracture Register; an observational study

Research article

The safe screw path along inferior border of the arcuate line at acetabular area: an anatomical study based on CT scans

Research article

Intertester and intratester reliability of movement control tests on the hip for patients with hip osteoarthritis