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Recruiting NCT06019585

Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures

No phase Interventional Distal Radius Fractures Internal Fixation; Complications, Mechanical

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Splint inmmobilization, Bandage immovilization.
Who it may be relevant to
Registry conditions: Distal Radius Fractures, Internal Fixation; Complications, Mechanical. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures Operated by Internal Fixation With Volar Locking Plate: A Pilot Study

Overview

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.

Interventions

  • Device Splint inmmobilization
    After internal fixation with volar locking plate, groups of distal radius fractures are inmobilized with a plaster splint of París for 3 weeks
  • Device Bandage immovilization
    After internal fixation with volar locking plate, groups of distal radius fractures are inmobilized with compressive bandage for 3 weeks

Primary outcome measures

  • Pain in Visual Analogue Scale. [Time frame: 1 year]
  • Function in Patient Rated Wrist Evaluation Scale. [Time frame: 1 year]
  • Range Of Motion in Flexion. [Time frame: 1 year]
  • Range Of Motion in Flexion. [Time frame: 1 year]
Secondary outcome measures (12)
  • Function in Disabilities of Arm, Shoulder and Hand Scale. [Time frame: 1 year]
  • Function in Mayo Wrist Score Scale. [Time frame: 1 year]
  • Range of motion in Supination. [Time frame: 1 year]
  • Number of participants with posoperative complications. [Time frame: 1 year]
  • Number of posoperative Fisiotherapy sessions performed. [Time frame: 1 year]
  • Time of fracture union in radiographs. [Time frame: 12 weeks]
  • Number of Instability distal radius fracture Criteria per participant. [Time frame: 1 year]
  • Grades of Dorsal Displacement in fracture. [Time frame: 6 weeks]
  • Range of motion in Pronation. [Time frame: 1 year]
  • Range of motion in Radial Deviation [Time frame: 1 year]
  • Range of motion in Ulnar deviation. [Time frame: 1 year]
  • Number of shortening millimeters in fracture. [Time frame: 6 weeks]

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.).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 2 centers
  • Hospital Reina Sofía — Córdoba
  • Hospital Costa del Sol — Málaga

Publications

  • 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. PMID 31579555
  • 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. PMID 28428911
  • 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. PMID 35186419
  • 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. PMID 25748659
  • 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: 10.2 PMID 21508285
  • 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. PMID 24508093
  • 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. PMID 23770202
  • 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. PMID 25157038

Identifiers

NCT: NCT06019585 · 003may21PIInmovilizacionfxd

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗