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

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...

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Main Authors: Marjolein A. M. Mulders, Caroline A. Selles, Joost W. Colaris, Rolf W. Peters, Mark van Heijl, Berry I. Cleffken, Niels W. L. Schep
Format: Article
Language:English
Published: BMC 2018-02-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-017-2409-2
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spelling doaj-d1dd7ddb582b43779d6be15eb220c48e2020-11-25T01:38:52ZengBMCTrials1745-62152018-02-011911810.1186/s13063-017-2409-2Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy: study protocol for a randomised controlled trialMarjolein A. M. Mulders0Caroline A. Selles1Joost W. Colaris2Rolf W. Peters3Mark van Heijl4Berry I. Cleffken5Niels W. L. Schep6Trauma Unit, Department of Surgery, Academic Medical Center, University of AmsterdamTrauma Unit, Department of Surgery, Academic Medical Center, University of AmsterdamDepartment of Orthopaedic Surgery, Erasmus Medical CenterTrauma Unit, Department of Surgery, Academic Medical Center, University of AmsterdamTrauma Unit, Department of Surgery, Academic Medical Center, University of AmsterdamDepartment of Surgery, Maasstad HospitalDepartment of Surgery, Maasstad HospitalAbstract 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.http://link.springer.com/article/10.1186/s13063-017-2409-2Distal radius fractureArticularDisplacedWrist arthroscopyWrist functionPRWE
collection DOAJ
language English
format Article
sources DOAJ
author Marjolein A. M. Mulders
Caroline A. Selles
Joost W. Colaris
Rolf W. Peters
Mark van Heijl
Berry I. Cleffken
Niels W. L. Schep
spellingShingle Marjolein A. M. Mulders
Caroline A. Selles
Joost W. Colaris
Rolf W. Peters
Mark van Heijl
Berry I. Cleffken
Niels W. L. Schep
Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy: study protocol for a randomised controlled trial
Trials
Distal radius fracture
Articular
Displaced
Wrist arthroscopy
Wrist function
PRWE
author_facet Marjolein A. M. Mulders
Caroline A. Selles
Joost W. Colaris
Rolf W. Peters
Mark van Heijl
Berry I. Cleffken
Niels W. L. Schep
author_sort Marjolein A. M. Mulders
title Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy: study protocol for a randomised controlled trial
title_short Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy: study protocol for a randomised controlled trial
title_full Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy: study protocol for a randomised controlled trial
title_fullStr Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy: study protocol for a randomised controlled trial
title_full_unstemmed Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy: study protocol for a randomised controlled trial
title_sort operative treatment of intra-articular distal radius fractures with versus without arthroscopy: study protocol for a randomised controlled trial
publisher BMC
series Trials
issn 1745-6215
publishDate 2018-02-01
description 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.
topic Distal radius fracture
Articular
Displaced
Wrist arthroscopy
Wrist function
PRWE
url http://link.springer.com/article/10.1186/s13063-017-2409-2
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