Clinical trial NCT06019585: Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures
Official title: Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures Operated by Internal Fixation With Volar Locking Plate: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Distal Radius Fractures
Internal Fixation; Complications, Mechanical
Keywords: distal radius fractures
volar plate
internal fixation
Inmobilization
Lead sponsor: Hospital Costa del Sol
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 parallel groups, each one receives one treatment
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare functional and radiological results in two groups of distal radius fractures treated with internal fixation with locking plate, and immobilized with antebrachial splint or compression bandage for 3 weeks.

Detailed description: The aim of the study is to compare functional and radiological results as well as to evaluate possible complications in distal radius fractures operated by open reduction and internal fixation with volar locking plate in two groups , one treated with immobilization using a forearm cast for 3 weeks and the other with immobilization using a compression bandage for 3 weeks, based on the hypothesis that compression bandage group could obtain better results in the short term, and none of the treatments is superior to the other after 3 or 6 months of evolution, as indicated by some reviewed studies.

Eligibility criteria: Inclusion Criteria:

* Patients with type A, B, C fractures of AO classification of distal radius fractures
* Patents aged between 18 and 75 years,
* Patients operated on in the first 3 weeks after the trauma, and independent for the basic activities of daily living

Exclusion Criteria:

* Patients with open fractures
* Patients with mental disorders (dementia, alcoholism, etc.),
* Patient dependent for basic activities of daily living
* Patients with fractures with severe articular and metaphyseal comminution and/or severe soft tissue injuries (type 2R3C3 AO),
* Patients with previous diseases or anatomical alterations in the injured wrist (previous fractures, rheumatoid arthritis, etc.).

Primary outcomes:
measure: Pain in Visual Analogue Scale.
timeFrame: 1 year
measure: Function in Patient Rated Wrist Evaluation Scale.
timeFrame: 1 year
measure: Range Of Motion in Flexion.
timeFrame: 1 year
measure: Range Of Motion in Flexion.
timeFrame: 1 year
Secondary outcomes:
measure: Function in Disabilities of Arm, Shoulder and Hand Scale.
timeFrame: 1 year
measure: Function in Mayo Wrist Score Scale.
timeFrame: 1 year
measure: Range of motion in Supination.
timeFrame: 1 year
measure: Number of participants with posoperative complications.
timeFrame: 1 year
measure: Number of posoperative Fisiotherapy sessions performed.
timeFrame: 1 year
measure: Time of fracture union in radiographs.
timeFrame: 12 weeks
measure: Number of Instability distal radius fracture Criteria per participant.
timeFrame: 1 year
measure: Grades of Dorsal Displacement in fracture.
timeFrame: 6 weeks
measure: Range of motion in Pronation.
timeFrame: 1 year
measure: Range of motion in Radial Deviation
timeFrame: 1 year
measure: Range of motion in Ulnar deviation.
timeFrame: 1 year
measure: Number of shortening millimeters in fracture.
timeFrame: 6 weeks
measure: Number of ulnar variance millimeters in fracture.
timeFrame: 6 weeks
measure: Number of step-off millimeters in fracture.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: Málaga
country: Spain
facility: Hospital Costa del Sol
Study officials:
affiliation: Hospital Reina Sofía ( Córdoba, Spain)
name: Alberto Izquierdo Fernández, Phd
role: STUDY_DIRECTOR
References:
citation: Delft EAKV, Gelder TGV, Vries R, Vermeulen J, Bloemers FW. Duration of Cast Immobilization in Distal Radial Fractures: A Systematic Review. J Wrist Surg. 2019 Oct;8(5):430-438. doi: 10.1055/s-0039-1683433. Epub 2019 Mar 18.
citation: Quadlbauer S, Pezzei C, Jurkowitsch J, Kolmayr B, Keuchel T, Simon D, Hausner T, Leixnering M. Early Rehabilitation of Distal Radius Fractures Stabilized by Volar Locking Plate: A Prospective Randomized Pilot Study. J Wrist Surg. 2017 May;6(2):102-112. doi: 10.1055/s-0036-1587317. Epub 2016 Aug 5.
citation: Toemen A, Collocott S, Heiss-Dunlop W. Short Term Outcomes Following Open Reduction Internal Fixation Surgery for a Distal Radius Fracture: 2 Week Versus 4 Week Immobilization. A Retrospective Analysis. Geriatr Orthop Surg Rehabil. 2021 Mar 25;12:21514593211004528. doi: 10.1177/21514593211004528. eCollection 2021.
citation: Klein SM, Prantl L, Koller M, Vykoukal J, Dolderer JH, Graf S, Nerlich M, Loibl M, Geis S. Evidence based postoperative treatment of distal radius fractures following internal locking plate fixation. Acta Chir Orthop Traumatol Cech. 2015;82(1):33-40.
citation: Lichtman DM, Bindra RR, Boyer MI, Putnam MD, Ring D, Slutsky DJ, Taras JS, Watters WC 3rd, Goldberg MJ, Keith M, Turkelson CM, Wies JL, Haralson RH 3rd, Boyer KM, Hitchcock K, Raymond L; American Academy of Orthopaedic Surgeons. American Academy of Orthopaedic Surgeons clinical practice guideline on: the treatment of distal radius fractures. J Bone Joint Surg Am. 2011 Apr 20;93(8):775-8. doi: 10.2106/JBJS.938ebo. No abstract available.
citation: Valdes K, Naughton N, Michlovitz S. Therapist supervised clinic-based therapy versus instruction in a home program following distal radius fracture: a systematic review. J Hand Ther. 2014 Jul-Sep;27(3):165-73; quiz 174. doi: 10.1016/j.jht.2013.12.010. Epub 2014 Jan 3.
citation: Driessens S, Diserens-Chew T, Burton C, Lassig E, Hartley C, McPhail S. A retrospective cohort investigation of active range of motion within one week of open reduction and internal fixation of distal radius fractures. J Hand Ther. 2013 Jul-Sep;26(3):225-30; quiz 231. doi: 10.1016/j.jht.2013.05.002. Epub 2013 Jun 14.
citation: Koval K, Haidukewych GJ, Service B, Zirgibel BJ. Controversies in the management of distal radius fractures. J Am Acad Orthop Surg. 2014 Sep;22(9):566-75. doi: 10.5435/JAAOS-22-09-566.
citation: Lozano-Calderon SA, Souer S, Mudgal C, Jupiter JB, Ring D. Wrist mobilization following volar plate fixation of fractures of the distal part of the radius. J Bone Joint Surg Am. 2008 Jun;90(6):1297-304. doi: 10.2106/JBJS.G.01368.
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.