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Open Access Study protocol

A randomized controlled trial of nonoperative treatment versus open reduction and internal fixation for stable, displaced, partial articular fractures of the radial head: the RAMBO trial

Wendy E Bruinsma1*, Izaäk F Kodde2, Robert-Jan O de Muinck Keizer1, Peter Kloen2, Anneluuk LC Lindenhovius2, Jos PAM Vroemen3, Robert Haverlag4, Michel PJ van den Bekerom5, Hugo W Bolhuis6, Pieter HJ Bullens7, Sven AG Meylaerts8, Peer van der Zwaal9, E Philip Steller10, Michiel Hageman11, David C Ring11, Dennis den Hartog12, Eric R Hammacher13, Graham JW King14, George S Athwal14, Kenneth J Faber14, Darren Drosdowech14, Ruby Grewal14, J Carel Goslings1, Niels WL Schep1 and Denise Eygendaal15

Author Affiliations

1 Trauma Unit, Department of Surgery, Academic Medical Center, Meibergdreef 9, 1100 DD Amsterdam, The Netherlands

2 Department of Orthopaedic Surgery, Academic Medical Center, Meibergdreef 9, 1100 DD Amsterdam, The Netherlands

3 Department of Trauma Surgery, Amphia Hospital, Molengracht 21, 4818 CK Breda, The Netherlands

4 Department of Surgery, OLVG Hospital, Oosterpark 9, 1091 AC Amsterdam, The Netherlands

5 Department of Orthopaedic Surgery, OLVG Hospital, Oosterpark 9, 1091 AC Amsterdam, The Netherlands

6 Department of Surgery, Gelre Hospital, Albert Schweitzerlaan 31, 7334 DZ Apeldoorn, The Netherlands

7 Department of Orthopaedic Surgery, Gelre Hospital, Albert Schweitzerlaan 31, 7334 DZ Apeldoorn, The Netherlands

8 Department of Surgery, Haaglanden Medical Center, Lijnbaan 32, 2512 VA The Hague, The Netherlands

9 Department of Orthopaedic Surgery, Haaglanden Medical Center, Lijnbaan 32, 2512 VA The Hague, The Netherlands

10 Department of Surgery, St. Lucas Andreas Hospital, Jan Tooropstraat 164, 1061 AE Amsterdam, The Netherlands

11 Department of Orthopaedic Surgery, Massachusetts General Hospital, 55 Fruit Street, Boston MA, USA

12 Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Postbus 2040Room Number H-815, 3000CA, Rotterdam, The Netherlands

13 Department of Trauma Surgery, Koekoekslaan 1, 3435 CM Nieuwegein, The Netherlands

14 Department of Orthopaedic Surgery, Roth McFarlane Hand and Upper Limb Centre, 268 Grosvenor Street, London, ON N6A 4L6, Canada

15 Department of Orthopaedic Surgery, Amphia Hospital, Molengracht 21, Molengracht 21, 4818 CK Breda, The Netherlands

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BMC Musculoskeletal Disorders 2014, 15:147  doi:10.1186/1471-2474-15-147

Published: 6 May 2014

Abstract

Background

The choice between operative or nonoperative treatment is questioned for partial articular fractures of the radial head that have at least 2 millimeters of articular step-off on at least one radiograph (defined as displaced), but less than 2 millimeter of gap between the fragments (defined as stable) and that are not associated with an elbow dislocation, interosseous ligament injury, or other fractures. These kinds of fractures are often classified as Mason type-2 fractures. Retrospective comparative studies suggest that operative treatment might be better than nonoperative treatment, but the long-term results of nonoperative treatment are very good. Most experts agree that problems like reduced range of motion, painful crepitation, nonunion or bony ankylosis are infrequent with both nonoperative and operative treatment of an isolated displaced partial articular fracture of the radial head, but determining which patients will have problems is difficult. A prospective, randomized comparison would help minimize bias and determine the balance between operative and nonoperative risks and benefits.

Methods/Design

The RAMBO trial (Radial Head – Amsterdam – Amphia – Boston - Others) is an international prospective, randomized, multicenter trial. The primary objective of this study is to compare patient related outcome defined by the ‘Disabilities of Arm, Shoulder and Hand (DASH) score’ twelve months after injury between operative and nonoperative treated patients. Adult patients with partial articular fractures of the radial head that comprise at least 1/3rd of the articular surface, have ≥ 2 millimeters of articular step-off but less than 2 millimeter of gap between the fragments will be enrolled. Secondary outcome measures will be the Mayo Elbow Performance Index (MEPI), the Oxford Elbow Score (OES), pain intensity through the ‘Numeric Rating Scale’, range of motion (flexion arc and rotational arc), radiographic appearance of the fracture (heterotopic ossification, radiocapitellar and ulnohumeral arthrosis, fracture healing, and signs of implant loosening or breakage) and adverse events (infection, nerve injury, secondary interventions) after one year.

Discussion

The successful completion of this trial will provide evidence on the best treatment for stable, displaced, partial articular fractures of the radial head.

Trial registration

The trial is registered at the Dutch Trial Register: NTR3413.

Keywords:
Radial head; Mason type 2; Operative; Nonoperative; Open reduction; Internal fixation; Randomized controlled trial