Dislocated distal radial fractures in adult patients: 4 weeks versus 6 weeks of cast immobilisation following reduction, a multicentre randomised controlled trial, study protocol

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Abstract

Introduction

Up to 30% of patients with a dislocated distal radial fracture (DRF) treated with closed reduction and cast immobilisation suffer from long-term functional restrictions. It remains unclear, whether duration of cast immobilisation influences functional outcome. The aim of this study is to evaluate whether the functional outcome of dislocated DRFs could be improved by shortening the period of immobilisation.

Methods and analysis

A single blinded multicentre randomised controlled trial is initiated. Four weeks of plaster cast immobilisation is compared with six week plaster cast immobilisation in adult patients with adequate reduced DRFs. Primary outcome parameters are functional outcome measured with the Patient Rated Wrist Evaluation after 1 year of follow-up (FU). Secondary outcomes are: Disability of Arm, Shoulder and Hand Score after 1 year, 36-Item Short Form Health Survey after 1 year, functional outcome earlier in FU (6 weeks, 12 weeks and 6 months), range of motion, pain level and complications: number of re-interventions, secondary dislocation, delayed and non-union.

Ethics and dissemination

The medical ethical committee VUmc approved the study protocol (2018.004, NL62861.029.17). The expectation of this study is that a shorter duration of plaster cast immobilisation is beneficial. This risk of specific complications is low and generally similar in both treatment options. FU is standardised according to current trauma guidelines. Present literature indicates that both treatment options that are used within this study are accepted protocols for treatment of dislocated DRFs. This trial will provide Level-I evidence for the comparison of functional outcome between the two treatment options for dislocated DRFs. Results of this study are expected to be published as a prospective, multicentre, randomised controlled trial article in 2021.

Trial registration

The Netherlands National Trial Register: NTR 6600, ABR: NL62861.029.17. Medical Ethical Committee VUmc registration number: 2018.004.

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Most cited references 18

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Patient rating of wrist pain and disability: a reliable and valid measurement tool.

J C MacDermid, T Turgeon, R S Richards … (2015)

The goal of this study was to develop a reliable and valid tool for quantifying patient-rated wrist pain and disability. Survey, tool development, reliability, and validity study. Upper extremity unit. One hundred members of the International Wrist Investigators were surveyed by mail to assist in development of the scale. Patients with distal radius (n = 64) or scaphoid (n = 35) fractures were enrolled in a reliability study, and 101 patients with distal radius fractures were enrolled in a validity study. Information from the expert survey, biomechanical literature, and patient interviews was used as a basis for item generation and definition of structural limitations for a scale that would be practical in the clinic. Patients with distal radius or scaphoid fractures completed the Patient-Rated Wrist Evaluation (PRWE) on two occasions to determine test-retest reliability. Patients with distal radius fractures (n = 101) completed the PRWE and the SF-36 and were tested with traditional impairment measures at baseline and at two, three, and six months after fracture to determine construct and criterion validity. Reliability coefficients (ICCs) and validity correlations (Pearson product moment correlations). Patient opinions on pain and on ability to do activities of daily living and work were thought to be the most important dimensions to include in subjective outcome tools. Brevity and simplicity were seen as essential in the clinic environment. A fifteen-item questionnaire (the PRWE) was designed to measure wrist pain and disability. Test-retest reliability was excellent (ICCs > 0.90). Validity assessment demonstrated that the instrument detected significant differences over time (p < 0.01) and was appropriately correlated with alternate forms of assessing parameters of pain and disability. The PRWE provides a brief, reliable, and valid measure of patient-rated pain and disability.

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The shortened disabilities of the arm, shoulder and hand questionnaire (QuickDASH): validity and reliability based on responses within the full-length DASH

Christina Gummesson, Michael M Ward, Isam Atroshi (2006)

Background The 30-item disabilities of the arm, shoulder and hand (DASH) questionnaire is increasingly used in clinical research involving upper extremity musculoskeletal disorders. From the original DASH a shorter version, the 11-item QuickDASH, has been developed. Little is known about the discriminant ability of score changes for the QuickDASH compared to the DASH. The aim of this study was to assess the performance of the QuickDASH and its cross-sectional and longitudinal validity and reliability. Methods The study was based on extracting QuickDASH item responses from the responses to the full-length DASH questionnaire completed by 105 patients with a variety of upper extremity disorders before surgery and at follow-up 6 to 21 months after surgery. The DASH and QuickDASH scores were compared for the whole population and for different diagnostic groups. For longitudinal construct validity the effect size and standardized response mean were calculated. Analyses with ROC curves were performed to compare the ability of the DASH and QuickDASH to discriminate among patients classified according to the magnitude of self-rated improvement. Cross-sectional and test-retest reliability was assessed. Results The mean DASH score was 34 (SD 22) and the mean QuickDASH score was 39 (SD 24) at baseline. For the different diagnostic groups the mean and median QuickDASH scores were higher than the corresponding DASH scores. For the whole population, the mean difference between the QuickDASH and DASH baseline scores was 4.2 (95% CI 3.2–5.3), follow-up scores was 2.6 (1.7–3.4), and change scores was 1.7 (0.6–2.8). The overall effect size and standardized response mean measured with the DASH and the QuickDASH were similar. In the ROC analysis of change scores among patients who rated their arm status as somewhat or much better and those who rated it as unchanged the difference in the area under the ROC curve for the DASH and QuickDASH was 0.01 (95% CI -0.05–0.07) indicating similar discriminant ability. Cross-sectional and test-retest reliability of the DASH and QuickDASH were similar. Conclusion The results indicate that the QuickDASH can be used instead of the DASH with similar precision in upper extremity disorders.

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The Minimum Clinically Important Difference of the Patient-rated Wrist Evaluation Score for Patients With Distal Radius Fractures

Monique Walenkamp, Robert-Jan de Muinck Keizer, J. Carel Goslings … (2015)

Background The Patient-rated Wrist Evaluation (PRWE) is a commonly used instrument in upper extremity surgery and in research. However, to recognize a treatment effect expressed as a change in PRWE, it is important to be aware of the minimum clinically important difference (MCID) and the minimum detectable change (MDC). The MCID of an outcome tool like the PRWE is defined as the smallest change in a score that is likely to be appreciated by a patient as an important change, while the MDC is defined as the smallest amount of change that can be detected by an outcome measure. A numerical change in score that is less than the MCID, even when statistically significant, does not represent a true clinically relevant change. To our knowledge, the MCID and MDC of the PRWE have not been determined in patients with distal radius fractures. Questions/Purposes We asked: (1) What is the MCID of the PRWE score for patients with distal radius fractures? (2) What is the MDC of the PRWE? Methods Our prospective cohort study included 102 patients with a distal radius fracture and a median age of 59 years (interquartile range [IQR], 48–66 years). All patients completed the PRWE questionnaire during each of two separate visits. At the second visit, patients were asked to indicate the degree of clinical change they appreciated since the previous visit. Accordingly, patients were categorized in two groups: (1) minimally improved or (2) no change. The groups were used to anchor the changes observed in the PRWE score to patients’ perspectives of what was clinically important. We determined the MCID using an anchor-based receiver operator characteristic method. In this context, the change in the PRWE score was considered a diagnostic test, and the anchor (minimally improved or no change as noted by the patients from visit to visit) was the gold standard. The optimal receiver operator characteristic cutoff point calculated with the Youden index reflected the value of the MCID. Results In our study, the MCID of the PRWE was 11.5 points. The area under the curve was 0.54 (95% CI, 0.37–0.70) for the pain subscale and 0.71 (95% CI, 0.57−0.85) for the function subscale. We determined the MDC to be 11.0 points. Conclusions We determined the MCID of the PRWE score for patients with distal radius fractures using the anchor-based approach and verified that the MDC of the PRWE was sufficiently small to detect our MCID. Clinical Relevance We recommend using an improvement on the PRWE of more than 11.5 points as the smallest clinically relevant difference when evaluating the effects of treatments and when performing sample-size calculations on studies of distal radius fractures.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2019

Publication date (Electronic): 15 March 2019

Volume: 9

Issue: 3

Electronic Location Identifier: e026540

Affiliations

[1 ] Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Trauma Surgery, Amsterdam Movement Sciences , the Netherlands

[2 ] Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Trauma Surgery , the Netherlands

[3 ] Spaarne Gasthuis, Department of Trauma Surgery , Haarlem, the Netherlands

[4 ] Amsterdam UMC, Vrije Universiteit Asmterdam, Department of Surgery , the Netherlands

[5 ] Maasstad Ziekenhuis, Department of Trauma Surgery , Rotterdam, the Netherlands

Author notes

[Correspondence to ] Mrs Eva A K van Delft; e.vandelft@ 123456vumc.nl

Author information

Eva A K van Delft http://orcid.org/0000-0002-2786-9158

Article

Publisher ID: bmjopen-2018-026540

DOI: 10.1136/bmjopen-2018-026540

PMC ID: 6429892

PubMed ID: 30878990

SO-VID: a6183eb7-92ce-4437-8f05-e0f13bb93c81

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This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

History

Date received : 22 October 2018

Date revision received : 18 December 2018

Date accepted : 21 December 2018

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ScienceOpen disciplines: Medicine

Keywords: distal radial fractures,conservative treatment,immobilisation period

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ScienceOpen disciplines: Medicine

Keywords: distal radial fractures, conservative treatment, immobilisation period

Dislocated distal radial fractures in adult patients: 4 weeks versus 6 weeks of cast immobilisation following reduction, a multicentre randomised controlled trial, study protocol

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Most cited references 18

Patient rating of wrist pain and disability: a reliable and valid measurement tool.

The shortened disabilities of the arm, shoulder and hand questionnaire (QuickDASH): validity and reliability based on responses within the full-length DASH

The Minimum Clinically Important Difference of the Patient-rated Wrist Evaluation Score for Patients With Distal Radius Fractures

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