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
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy: study protocol for a randomised controlled trial

Authors: Marjolein A. M. Mulders, Caroline A. Selles, Joost W. Colaris, Rolf W. Peters, Mark van Heijl, Berry I. Cleffken, Niels W. L. Schep

Published in: Trials | Issue 1/2018

Login to get access

Abstract

Background

In the past several years, an increase in open reduction and internal fixation (ORIF) for intra-articular distal radius fractures has been observed. This technique leads to a quicker recovery of function compared to non-operative treatment. However, some patients continue to have a painful and stiff wrist postoperatively. Arthroscopically assisted removal of intra-articular fracture haematoma and debris may improve the functional outcomes following operative treatment of intra-articular distal radius fractures. The purpose of this randomised controlled trial is to determine the difference in functional outcome, assessed with the Patient-Rated Wrist Evaluation (PRWE) score, after ORIF with and without an additional wrist arthroscopy in adult patients with displaced complete articular distal radius fractures.

Methods

In this multicentre trial, adult patients with a displaced complete articular distal radius fracture are randomised between ORIF with an additional wrist arthroscopy to remove fracture haematoma and debris (intervention group) and conventional fluoroscopic-assisted ORIF (control group). The primary outcome is functional outcome assessed with the PRWE score after three months. Secondary outcomes are wrist function assessed with the Disability of the Arm, Shoulder and Hand (DASH) score, postoperative pain, range of motion, grip strength, complications and cost-effectiveness. Additionally, in the intervention group, the quality of reduction, associated ligamentous injuries and cartilage damage will be assessed. A total of 50 patients will be included in this study.

Discussion

Although ORIF of intra-articular distal radius fractures leads to a quicker resume of function compared to non-operative treatment, some patients continue to have a painful and stiff wrist postoperatively. We hypothesise that, due to the removal of fracture haematoma and debris by an additional arthroscopy, functional outcomes will be better compared to the non-arthroscopically treated group.

Trial registration

ClinicalTrials.gov, NCT02660515. Registered on 13 January 2016.
Appendix
Available only for authorised users
Literature
1.
Koval KJ, Harrast JJ, Anglen JO, Weinstein JN. Fractures of the distal part of the radius. The evolution of practice over time. Where’s the evidence? J Bone Joint Surg Am. 2008;90:1855–61.CrossRefPubMed
2.
Schneppendahl J, Windolf J, Kaufmann RA. Distal radius fractures: current concepts. J Hand Surg [Am]. 2012;37:1718–25.CrossRef
3.
Mattila VM, Huttunen TT, Sillanpaa P, Niemi S, Pihlajamaki H, Kannus P. Significant change in the surgical treatment of distal radius fractures: a nationwide study between 1998 and 2008 in Finland. J Trauma. 2011;71:939–42. discussion 942–933.CrossRefPubMed
4.
Bentohami A, Bosma J, Akkersdijk GJM, van Dijkman B, Goslings JC, Schep NWL. Incidence and characteristics of distal radial fractures in an urban population in The Netherlands. Eur J TraumaEmerg Surg. 2014;40:357–61.
5.
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;93:2146–53.CrossRefPubMed
6.
Bartl C, Stengel D, Bruckner T, Gebhard F. The treatment of displaced intra-articular distal radius fractures in elderly patients. Dtsch Arztebl Int. 2014;111:779–87.PubMedPubMedCentral
7.
Ruch DS, Vallee J, Poehling GG, Smith BP, Kuzma GR. Arthroscopic reduction versus fluoroscopic reduction in the management of intra-articular distal radius fractures. Arthroscopy. 2004;20:225–30.CrossRefPubMed
8.
Auge 2nd WK, Velazquez PA. The application of indirect reduction techniques in the distal radius: the role of adjuvant arthroscopy. Arthroscopy. 2000;16:830–5.CrossRefPubMed
9.
Edwards 2nd CC, Haraszti CJ, McGillivary GR, Gutow AP. Intra-articular distal radius fractures: arthroscopic assessment of radiographically assisted reduction. J Hand Surg [Am]. 2001;26:1036–41.CrossRef
10.
Ono H, Furuta K, Fujitani R, Katayama T, Akahane M. Distal radius fracture arthroscopic intraarticular displacement measurement after open reduction and internal fixation from a volar approach. J Orthop Sci. 2010;15:502–8.CrossRefPubMed
11.
Geissler WB, Freeland AE, Savoie FH, McIntyre LW, Whipple TL. Intracarpal soft-tissue lesions associated with an intra-articular fracture of the distal end of the radius. J Bone Joint Surg Am. 1996;78:357–65.CrossRefPubMed
12.
Peicha G, Seibert F, Fellinger M, Grechenig W. Midterm results of arthroscopic treatment of scapholunate ligament lesions associated with intra-articular distal radius fractures. Knee Surg Sports Traumatol Arthrosc. 1999;7:327–33.CrossRefPubMed
13.
Ruch DS, Yang CC, Smith BP. Results of acute arthroscopically repaired triangular fibrocartilage complex injuries associated with intra-articular distal radius fractures. Arthroscopy. 2003;19:511–6.CrossRefPubMed
14.
Lindau T, Arner M, Hagberg L. Intraarticular lesions in distal fractures of the radius in young adults. A descriptive arthroscopic study in 50 patients. J Hand Surg Br. 1997;22:638–43.CrossRefPubMed
15.
Vener MJ, Thompson Jr RC, Lewis JL, Oegema Jr TR. Subchondral damage after acute transarticular loading: an in vitro model of joint injury. J Orthop Res. 1992;10:759–65.CrossRefPubMed
16.
Mrkonjic A, Geijer M, Lindau T, Tagil M. The natural course of traumatic triangular fibrocartilage complex tears in distal radial fractures: a 13-15 year follow-up of arthroscopically diagnosed but untreated injuries. J Hand Surg [Am]. 2012;37:1555–60.CrossRef
17.
Yamazaki H, Uchiyama S, Komatsu M, Hashimoto S, Kobayashi Y, Sakurai T, et al. Arthroscopic assistance does not improve the functional or radiographic outcome of unstable intra-articular distal radial fractures treated with a volar locking plate: a randomised controlled trial. Bone Joint J. 2015;97-b:957–62.CrossRefPubMed
18.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krle AJK, et al. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Rev Panam Salud Publica. 2015;38:506–14.PubMedPubMedCentral
19.
20.
Ono H, Katayama T, Furuta K, Suzuki D, Fujitani R, Akahane M. Distal radial fracture arthroscopic intraarticular gap and step-off measurement after open reduction and internal fixation with a volar locked plate. J Orthop Sci. 2012;17:443–9.CrossRefPubMed
21.
Henry MH, Griggs SM, Levaro F, Clifton J, Masson MV. Volar approach to dorsal displaced fractures of the distal radius. Tech Hand Up Extrem Surg. 2001;5:31–41.CrossRefPubMed
22.
Outerbridge RE. The etiology of chondromalacia patellae. Clin Orthop Relat Res. 2001;1961:5–8.CrossRef
23.
Palmer AK. Triangular fibrocartilage complex lesions: a classification. J Hand Surg [Am]. 1989;14:594–606.CrossRef
24.
Changulani M, Okonkwo U, Keswani T, Kalairajah Y. Outcome evaluation measures for wrist and hand: which one to choose? Int Orthop. 2008;32:1–6.CrossRefPubMed
25.
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.CrossRefPubMed
26.
El Moumni M, Van Eck ME, Wendt KW, Reininga IH, Mokkink LB. Structural validity of the Dutch version of the Patient-Rated Wrist Evaluation (PRWE-NL) in patients with hand and wrist injuries. Phys Ther. 2016;96:908–16.CrossRefPubMed
27.
Brogren E, Hofer M, Petranek M, Wagner P, Dahlin LB, Atroshi I. Relationship between distal radius fracture malunion and arm-related disability: a prospective population-based cohort study with 1-year follow-up. BMC Musculoskelet Disord. 2011;12:9.CrossRefPubMedPubMedCentral
28.
Calfee RP, Adams AA. Clinical research and patient-rated outcome measures in hand surgery. J Hand Surg [Am]. 2012;37:851–5.CrossRef
29.
Hoang-Kim A, Pegreffi F, Moroni A, Ladd A. Measuring wrist and hand function: common scales and checklists. Injury. 2011;42:253–8.CrossRefPubMed
30.
Raven EE, Haverkamp D, Sierevelt IN, van Montfoort DO, Poll RG, Blankevoort L, et al. Construct validity and reliability of the disability of arm, shoulder and hand questionnaire for upper extremity complaints in rheumatoid arthritis. J Rheumatol. 2008;35:2334–8.CrossRefPubMed
31.
Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999;1999(20):250–78. quiz 279–280.
32.
Veldman PHJM, Reynen HM, Arntz IE, Goris RJA. Signs and symptoms of reflex sympathetic dystrophy: Prospective study of 829 patients. Lancet. 1993;342:1012–6.CrossRefPubMed
33.
Harden RN, Bruehl S, Perez RS, Birklein F, Marinus J, Maihofner C, et al. Validation of proposed diagnostic criteria (the “Budapest Criteria”) for complex regional pain syndrome. Pain. 2010;150:268–74.CrossRefPubMedPubMedCentral
34.
Harden RN, Bruehl S, Stanton-Hicks M, Wilson PR. Proposed new diagnostic criteria for complex regional pain syndrome. Pain Med. 2007;8:326–31.CrossRefPubMed
35.
Mulders MA, Walenkamp MM, Goslings JC, Schep NW. Internal plate fixation versus plaster in displaced complete articular distal radius fractures, a randomised controlled trial. BMC Musculoskelet Disord. 2016;17:68.CrossRefPubMedPubMedCentral
36.
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.CrossRefPubMedPubMedCentral
37.
Walenkamp MM, de Muinck Keizer RJ, 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;473:3235–41.CrossRefPubMedPubMedCentral
Metadata
Title
Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy: study protocol for a randomised controlled trial
Authors
Marjolein A. M. Mulders
Caroline A. Selles
Joost W. Colaris
Rolf W. Peters
Mark van Heijl
Berry I. Cleffken
Niels W. L. Schep
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2409-2

Other articles of this Issue 1/2018

Trials 1/2018 Go to the issue

Study protocol

Efficacy and cost-effectiveness of a community-based model of care for older patients with complex needs: a study protocol for a multicentre randomised controlled trial using a stepped wedge cluster design

Study protocol

ALternatives To prophylactic Antibiotics for the treatment of Recurrent urinary tract infection in women (ALTAR): study protocol for a multicentre, pragmatic, patient-randomised, non-inferiority trial

Review

Application of causal inference methods in the analyses of randomised controlled trials: a systematic review

Study protocol

Mindfulness as a complementary intervention in the treatment of overweight and obesity in primary health care: study protocol for a randomised controlled trial

Study protocol

Telerehabilitation for aphasia – protocol of a pragmatic, exploratory, pilot randomized controlled trial

Study protocol

Apatinib for patients with advanced or recurrent cervical cancer: study protocol for an open-label randomized controlled trial