Clinical trial NCT05580848: Wrist Arthroscopy During Surgical Treatment of Distal Radius Fractures
Official title: Wrist Arthroscopy During Surgical Treatment of Distal Radius Fractures Improves Functional Outcome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture
Radius Fracture Distal
Keywords: Arthroscopy
Radius Fractures
Surveys and Questionnaires
Treatment Outcome
Wrist
Lead sponsor: Clinic for Orthopedics Lovran
Sponsor class: OTHER
Collaborators: name: University of Rijeka, The Faculty of Medicine
First posted: 2022-10-14
Enrollment: 56
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Wrist arthroscopy (WA) is a potentially useful adjuvant procedure in the surgical treatment (osteosynthesis) of distal radius fractures (DRFs). Previous research on the contribution of WA to DRF treatment has shown different results.

Objectives of the study: (1) Validate wrist functional outcome questionnaires; (2) To determine whether arthroscopically assisted repositioning of fracture fragments in articular DRFs leads to a better treatment outcome; (3) To determine whether arthroscopic observation and treatment of associated soft tissue and / or cartilage injuries in articular DRFs leads to a better treatment outcome; (4) To determine whether arthroscopic observation and treatment of associated soft tissue and / or cartilage injuries in extraarticular DRFs leads to a better treatment outcome.

Research hypotheses: (1) Validated questionnaires will have satisfactory measurement properties (validity, reliability) and will be able to be used in a WA randomized controlled trial; (2) WA as an adjunct to DRF osteosynthesis improves the clinical outcome of treatment.

Subjects: 56 female patients with indication for DRF osteosynthesis aged 50-69 years divided into 2 groups: 1. examined - 28 patients with indication for DRF osteosynthesis (14 patients with extraarticular DRF and 14 patients with intraarticular DRF) with associated WA, and 2. control - 28 patients with indication for DRF osteosynthesis (14 patients with extraarticular DRF and 14 patients with intraarticular DRF) without associated WA.

Methods: As a primary outcome measure, functional outcomes of treatment will be analyzed with the Disabilities of the Arm, Shoulder and Hand (DASH) Score at 3 and 6 months after surgery. As a secondary outcome measures it will be analyzed pain level according to a visual analog scale (VAS), preoperative and postoperative radiographic parameters of distal radius, and clinical outcomes of treatment with the Mayo Wrist Score (MWS) and Patient-Rated Wrist Evaluation (PRWE) score at 3 and 6 months after surgery. Expected scientific contribution: providing answers on the role of WA in the treatment of DRF and associated injuries as well as its impact on treatment outcome.


Eligibility criteria: Inclusion Criteria:

* Distal radius fractures with an indication for surgical treatment according to the AO/OTA classification of patients aged 50-69 years who have signed an informed consent to participate in the research.

Exclusion Criteria:

* Distal radius fractures( DRF) that have an indication for surgical treatment in all patients and in patients younger than 50 and older than 69,
* DRF that do not have an indication for surgical treatment,
* Refusal to participate in the research,
* Inability to decide independently about participation in the research (persons under guardianship),
* Open fractures,
* Presence of severe soft tissue injuries,
* Infections,
* Poor general condition of patients and internal medicine contraindications.

Primary outcomes:
measure: DASH Score
timeFrame: 3 months after surgery
measure: DASH Score
timeFrame: 6 months after surgery
Secondary outcomes:
measure: VAS
timeFrame: 3 months after surgery.
measure: VAS
timeFrame: 6 months after surgery.
measure: MWS
timeFrame: 3 months after surgery.
measure: MWS
timeFrame: 6 months after surgery.
measure: PRWE
timeFrame: 3 months after surgery.
measure: PRWE
timeFrame: 6 months after surgery.
Other outcomes:
Locations:
Study officials:
References:
citation: Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.
citation: Rundgren J, Bojan A, Mellstrand Navarro C, Enocson A. Epidemiology, classification, treatment and mortality of distal radius fractures in adults: an observational study of 23,394 fractures from the national Swedish fracture register. BMC Musculoskelet Disord. 2020 Feb 8;21(1):88. doi: 10.1186/s12891-020-3097-8.
citation: Ochen Y, Peek J, van der Velde D, Beeres FJP, van Heijl M, Groenwold RHH, Houwert RM, Heng M. Operative vs Nonoperative Treatment of Distal Radius Fractures in Adults: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Apr 1;3(4):e203497. doi: 10.1001/jamanetworkopen.2020.3497.
citation: Song J, Yu AX, Li ZH. Comparison of conservative and operative treatment for distal radius fracture: a meta-analysis of randomized controlled trials. Int J Clin Exp Med. 2015 Oct 15;8(10):17023-35. eCollection 2015.
citation: Ju JH, Jin GZ, Li GX, Hu HY, Hou RX. Comparison of treatment outcomes between nonsurgical and surgical treatment of distal radius fracture in elderly: a systematic review and meta-analysis. Langenbecks Arch Surg. 2015 Oct;400(7):767-79. doi: 10.1007/s00423-015-1324-9. Epub 2015 Aug 30.
citation: Chen Y, Chen X, Li Z, Yan H, Zhou F, Gao W. Safety and Efficacy of Operative Versus Nonsurgical Management of Distal Radius Fractures in Elderly Patients: A Systematic Review and Meta-analysis. J Hand Surg Am. 2016 Mar;41(3):404-13. doi: 10.1016/j.jhsa.2015.12.008. Epub 2016 Jan 20.
citation: Armstrong KA, von Schroeder HP, Baxter NN, Zhong T, Huang A, McCabe SJ. Stable rates of operative treatment of distal radius fractures in Ontario, Canada: a population-based retrospective cohort study (2004-2013). Can J Surg. 2019 Dec 1;62(6):386-392. doi: 10.1503/cjs.016218.
citation: Mauck BM, Swigler CW. Evidence-Based Review of Distal Radius Fractures. Orthop Clin North Am. 2018 Apr;49(2):211-222. doi: 10.1016/j.ocl.2017.12.001.
citation: Cazzola M, Bergamaschi G, Melazzini M, Ponchio L, Rosti V, Molinari E. Chronic myelogenous leukemia following radiotherapy and chemotherapy for non-Hodgkin lymphoma. Haematologica. 1990 Sep-Oct;75(5):477-9.
citation: Baron JA, Karagas M, Barrett J, Kniffin W, Malenka D, Mayor M, Keller RB. Basic epidemiology of fractures of the upper and lower limb among Americans over 65 years of age. Epidemiology. 1996 Nov;7(6):612-8. doi: 10.1097/00001648-199611000-00008.
citation: Brogren E, Petranek M, Atroshi I. Incidence and characteristics of distal radius fractures in a southern Swedish region. BMC Musculoskelet Disord. 2007 May 31;8:48. doi: 10.1186/1471-2474-8-48.
citation: Mellstrand-Navarro C, Pettersson HJ, Tornqvist H, Ponzer S. The operative treatment of fractures of the distal radius is increasing: results from a nationwide Swedish study. Bone Joint J. 2014 Jul;96-B(7):963-9. doi: 10.1302/0301-620X.96B7.33149.
citation: Stirling ERB, Johnson NA, Dias JJ. Epidemiology of distal radius fractures in a geographically defined adult population. J Hand Surg Eur Vol. 2018 Nov;43(9):974-982. doi: 10.1177/1753193418786378. Epub 2018 Jul 17.
citation: Solvang HW, Nordheggen RA, Clementsen S, Hammer OL, Randsborg PH. Epidemiology of distal radius fracture in Akershus, Norway, in 2010-2011. J Orthop Surg Res. 2018 Aug 13;13(1):199. doi: 10.1186/s13018-018-0904-0.
citation: Whipple TL. The role of arthroscopy in the treatment of intra-articular wrist fractures. Hand Clin. 1995 Feb;11(1):13-8.
citation: Lutsky K, Boyer MI, Steffen JA, Goldfarb CA. Arthroscopic assessment of intra-articular distal radius fractures after open reduction and internal fixation from a volar approach. J Hand Surg Am. 2008 Apr;33(4):476-84. doi: 10.1016/j.jhsa.2007.12.009.
citation: Jotanović Z, Mamula M, Vlahović T, i sur. Wrist arthroscopy. Medicina Flum 2013;49(3):292- 300.
citation: Burnier M, Le Chatelier Riquier M, Herzberg G. Treatment of intra-articular fracture of distal radius fractures with fluoroscopic only or combined with arthroscopic control: A prospective tomodensitometric comparative study of 40 patients. Orthop Traumatol Surg Res. 2018 Feb;104(1):89-93. doi: 10.1016/j.otsr.2017.08.021. Epub 2017 Dec 11.
citation: 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 Mar;78(3):357-65. doi: 10.2106/00004623-199603000-00006.
citation: Ogawa T, Tanaka T, Yanai T, Kumagai H, Ochiai N. Analysis of soft tissue injuries associated with distal radius fractures. BMC Sports Sci Med Rehabil. 2013 Sep 2;5(1):19. doi: 10.1186/2052-1847-5-19.
citation: Swart E, Tang P. The Effect of Ligament Injuries on Outcomes of Operatively Treated Distal Radius Fractures. Am J Orthop (Belle Mead NJ). 2017 Jan/Feb;46(1):E41-E46.
citation: Smeraglia F, Del Buono A, Maffulli N. Wrist arthroscopy in the management of articular distal radius fractures. Br Med Bull. 2016 Sep;119(1):157-65. doi: 10.1093/bmb/ldw032. Epub 2016 Aug 22.
citation: Saab M, Guerre E, Chantelot C, Clavert P, Ehlinger M, Bauer T; SoFCOT. Contribution of arthroscopy to the management of intra-articular distal radius fractures: Knowledge update based on a systematic 10-year literature review. Orthop Traumatol Surg Res. 2019 Dec;105(8):1617-1625. doi: 10.1016/j.otsr.2019.06.016. Epub 2019 Sep 13.
citation: Yamazaki H, Uchiyama S, Komatsu M, Hashimoto S, Kobayashi Y, Sakurai T, Kato H. 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 Jul;97-B(7):957-62. doi: 10.1302/0301-620X.97B7.35354.
citation: Kasapinova K, Kamiloski V. Influence of associated lesions of the intrinsic ligaments on distal radius fractures outcome. Arch Orthop Trauma Surg. 2015 Jun;135(6):831-8. doi: 10.1007/s00402-015-2203-0. Epub 2015 Mar 25.
citation: Varitimidis SE, Basdekis GK, Dailiana ZH, Hantes ME, Bargiotas K, Malizos K. Treatment of intra-articular fractures of the distal radius: fluoroscopic or arthroscopic reduction? J Bone Joint Surg Br. 2008 Jun;90(6):778-85. doi: 10.1302/0301-620X.90B6.19809.
citation: Boateng GO, Neilands TB, Frongillo EA, Melgar-Quinonez HR, Young SL. Best Practices for Developing and Validating Scales for Health, Social, and Behavioral Research: A Primer. Front Public Health. 2018 Jun 11;6:149. doi: 10.3389/fpubh.2018.00149. eCollection 2018.
citation: Meinberg EG, Agel J, Roberts CS, Karam MD, Kellam JF. Fracture and Dislocation Classification Compendium-2018. J Orthop Trauma. 2018 Jan;32 Suppl 1:S1-S170. doi: 10.1097/BOT.0000000000001063. No abstract available.
citation: Tsang S, Royse CF, Terkawi AS. Guidelines for developing, translating, and validating a questionnaire in perioperative and pain medicine. Saudi J Anaesth. 2017 May;11(Suppl 1):S80-S89. doi: 10.4103/sja.SJA_203_17.
citation: Sousa VD, Rojjanasrirat W. Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline. J Eval Clin Pract. 2011 Apr;17(2):268-74. doi: 10.1111/j.1365-2753.2010.01434.x. Epub 2010 Sep 28.
citation: Palmer AK. Triangular fibrocartilage complex lesions: a classification. J Hand Surg Am. 1989 Jul;14(4):594-606. doi: 10.1016/0363-5023(89)90174-3.
citation: Viegas SF, Patterson RM, Peterson PD, Pogue DJ, Jenkins DK, Sweo TD, Hokanson JA. Ulnar-sided perilunate instability: an anatomic and biomechanic study. J Hand Surg Am. 1990 Mar;15(2):268-78. doi: 10.1016/0363-5023(90)90107-3.
citation: Robert H, Lambotte JC, Flicoteaux R. Arthroscopic Measurement of Cartilage Lesions of the Knee Condyle: Principles and Experimental Validation of a New Method. Cartilage. 2011 Jul;2(3):237-45. doi: 10.1177/1947603510388028.