A protocol for a single-center, single-blinded randomized-controlled trial investigating volar plating versus conservative treatment of unstable distal radius fractures in patients older than 65 years

Jonas Pedersen, Simon Oksbjerre Mortensen, Jan Duedal Rölfing, Rikke Thorninger, Jonas Pedersen, Simon Oksbjerre Mortensen, Jan Duedal Rölfing, Rikke Thorninger

Abstract

Background: Distal radius fractures (DRF) are very common in elderly patients, who present at the Emergency Department. Surgical treatment with open reduction and internal fixation using volar locking plates is widely prevalent despite the lack of evidence proving its superiority to conservative treatment with closed reduction and plaster immobilization. The purpose of this study is to investigate whether conservative treatment is superior to volar plating in terms of number of complications and results in a comparable or superior functional outcome in patients ≥65 years.

Methods: In this single-center, single-blinded randomized-controlled trial, patients ≥65 years with distal radius fractures will be invited to participate. A total of 50 patients per treatment arm is required to provide 80% statistical power at a 5% alpha level assuming a difference of 20% in complication rate between operatively and conservatively treated patients. Primary outcome measures will be complication rate, Quick DASH score (Quick Disabilities of the Arm, Shoulder and Hand), PRWE (Patient rated Wrist evaluation), and range of motion of the wrist. Secondary outcome measures will be grip strength, pinch gauge, pain, use of pain medication EQ5D score (European Quality of life - 5 dimensions), standardized radiographs. One year of follow-up is planned with data collection at the day of injury, after 2 weeks, after 5 weeks, after 6 months, and after 12 months. An intention-totreat and per-protocol analysis will be performed.

Discussion: This prospective trial helps to clarify the best treatment strategy for displaced DRF patients ≥65 years.

Trial registration: This trial is approved by the Danish Scientific Ethical Committee (ID: 1-10-72-420-17) and registered at Clinicaltrials.gov (Trial registration number NCT03716661 ).

Keywords: Complications; Conservative; Distal radius fractures; Elderly; Functional outcome; Volar plating.

Conflict of interest statement

RT is consultant for Acumed. The other authors have no conflict of interest.

Figures

Fig. 1
Fig. 1
Study Design. An overview of the study design showing the 3 arms. *These radiographs are evaluated respectively after study completion and do not influent the prospective follow-up of the individual patient
Fig. 2
Fig. 2
Illustration of the randomisation process regarding intervention groups, e.g. treatment arm 1 and 2. Each dot represents a sealed, opaque envelope that contains a note with the treatment arm allocation. The blue and red dots represent “conservative” and “operative” treatment, respectively. Whenever only 3 envelopes are left, 5 new “operative” and 5 new “conservative” treatment envelopes are mixed and added
Fig. 3
Fig. 3
A demonstration of the blinding of treatment using a glove

References

    1. Baron JA. Basic epidemiology of fractures of the upper and lower limb among Americans over 65 years of age. Epidemiology (Cambridge, Mass) 1996;7(6):612–618. doi: 10.1097/00001648-199611000-00008.
    1. Christensen M. Treatment of distal radius fractures in the elderly. Ugeskr Laeger. 2015;177(34). .
    1. Thorninger R. Complications of volar locking plating of distal radius fractures in 576 patients with 3.2 years follow-up. Injury. 2017;48(6):1104–1109. doi: 10.1016/j.injury.2017.03.008.
    1. Brogren E. Incidence and characteristics of distal radius fractures in a southern Swedish region. BMC Musculoskelet Disord. 2007;8(1):48. doi: 10.1186/1471-2474-8-48.
    1. Flinkkilä T. Epidemiology and seasonal variation of distal radius fractures in Oulu, Finland. Osteoporos Int. 2011;22(8):2307–2312. doi: 10.1007/s00198-010-1463-3.
    1. Hernlund E, Svedbom A, Ivergard M, Compston J, Cooper C, Stenmark J, et al. Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA) Arch Osteoporos. 2013;8:136. doi: 10.1007/s11657-013-0136-1.
    1. Statistics Denmark Population Projection 2018–2060; 27 Mar 2019. Available from: .
    1. Sundhedssyrelsen . Nationale Kliniske Retningslinjer for behandling af håndledsnære brud (distal radius fraktur) 2014.
    1. Madsen ML, Waever D, Borris LC, Nagel LL, Henriksen M, Thorninger R, et al. Volar plating of distal radius fractures does not restore the anatomy. Dan Med J. 2018;(8):65. .
    1. Wichlas F, Haas NP, Disch A, Macho D, Tsitsilonis S. Complication rates and reduction potential of palmar versus dorsal locking plate osteosynthesis for the treatment of distal radius fractures. J Orthop Traumatol. 2014;15(4):259–264. doi: 10.1007/s10195-014-0306-y.
    1. Arora R, Lutz M, Hennerbichler A, Krappinger D, Espen D, Gabl M. Complications following internal fixation of unstable distal radius fracture with a palmar locking-plate. J Orthop Trauma. 2007;21(5):316–322. doi: 10.1097/BOT.0b013e318059b993.
    1. Williksen JH, Frihagen F, Hellund JC, Kvernmo HD, Husby T. Volar locking plates versus external fixation and adjuvant pin fixation in unstable distal radius fractures: a randomized, controlled study. J Hand Surg. 2013;38(8):1469–1476. doi: 10.1016/j.jhsa.2013.04.039.
    1. Rampoldi M, Marsico S. Complications of volar plating of distal radius fractures. Acta Orthop Belg. 2007;73(6):714–719.
    1. Snoddy MC, An TJ, Hooe BS, Kay HF, Lee DH, Pappas ND. Incidence and reasons for hardware removal following operative fixation of distal radius fractures. J Hand Surg. 2015;40(3):505–507. doi: 10.1016/j.jhsa.2014.11.022.
    1. Shauver MJ. An economic analysis of outcomes and complications of treating distal radius fractures in the elderly. J Hand Surg (American ed) 2011;36(12):1912–8.e3. doi: 10.1016/j.jhsa.2011.09.039.
    1. Arora R. 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 Vol) 2011;93(23):2146–2153. doi: 10.2106/JBJS.J.01597.
    1. Lutz K. Complications associated with operative versus nonsurgical treatment of distal radius fractures in patients aged 65 years and older. J Hand Surg (American ed) 2014;39(7):1280–1286. doi: 10.1016/j.jhsa.2014.04.018.
    1. van Leerdam Roderick H, Huizing Floortje, Termaat Frank, Kleinveld Sanne, Rhemrev Steven J, Krijnen Pieta, Schipper Inger B. Patient-reported outcomes after a distal radius fracture in adults: a 3–4 years follow-up. Acta Orthopaedica. 2019;90(2):129–134. doi: 10.1080/17453674.2019.1568098.
    1. Franchignoni F, Vercelli S, Giordano A, Sartorio F, Bravini E, Ferriero G. Minimal clinically important difference of the disabilities of the arm, shoulder and hand outcome measure (DASH) and its shortened version (QuickDASH) J Orthop Sports Phys Ther. 2014;44(1):30–39. doi: 10.2519/jospt.2014.4893.
    1. Mintken PE, Glynn P, Cleland JA. Psychometric properties of the shortened disabilities of the arm, shoulder, and hand questionnaire (QuickDASH) and numeric pain rating scale in patients with shoulder pain. J Shoulder Elb Surg. 2009;18(6):920–926. doi: 10.1016/j.jse.2008.12.015.
    1. The DASH Outcome Measure - Disabilities of the Arm, Shoulder, and Hand Available from: . Accessed 26 June 2019.
    1. Schonnemann JO, Eggers J. Validation of the Danish version of the quick-disabilities of arm, shoulder and hand questionnaire. Dan Med J. 2016;63(12). .
    1. Hansen AØ, Knygsand-Roenhoej K, Ardensø K. Danish version of the patient-rated wrist/hand evaluation questionnaire: translation, cross-cultural adaptation, test–retest reliability and construct validity. Hand Ther. 2019;24(1):22–30. doi: 10.1177/1758998318807238.
    1. Wittrup-Jensen KU, Lauridsen J, Gudex C, Pedersen KM. Generation of a Danish TTO value set for EQ-5D health states. Scand J Public Health. 2009;37(5):459–466. doi: 10.1177/1403494809105287.
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–381. doi: 10.1016/j.jbi.2008.08.010.

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner