Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures

NCT06019585 | Recruiting DMC

• 1 other identifier: 003may21PIInmovilizacionfxd
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Distal Radius Fractures; Internal Fixation; Complications, Mechanical

Keywords

distal radius fractures; volar plate; internal fixation; Inmobilization

Outcome Measures

Primary Outcomes (4)

• Pain in Visual Analogue Scale.

  Points from 1 to 10. Higher score: worse value. Lower score: better value.

  1 year

• Function in Patient Rated Wrist Evaluation Scale.

  Points from 1 to 100. Higher score: worse value. Lower score: better value.

  1 year

• Range Of Motion in Flexion.

  Grades from 0 to 70. Higher score: better value. Lower score: worse value.

  1 year

• Range Of Motion in Flexion.

  Grades from 0 to 80. Higher score: better value. Lower score: worse value.

  1 year

Secondary Outcomes (14)

• Function in Disabilities of Arm, Shoulder and Hand Scale.

  1 year

• Function in Mayo Wrist Score Scale.

  1 year

• Range of motion in Supination.

  1 year

• Number of participants with posoperative complications.

  1 year

• Number of posoperative Fisiotherapy sessions performed.

  1 year

Study Arms (2)

Splint inmmobilization

ACTIVE COMPARATOR

Distal radius fractures fixed with volar locking plate and immobilized with an antebrachial splint for 3 weeks

Device: Splint inmmobilization

Bandage immovilization

ACTIVE COMPARATOR

Distal radius fractures fixed with volar locking plate and immobilized with a compressive bandage for 3 weeks

Device: Bandage immovilization

Interventions

Splint inmmobilization DEVICE

After internal fixation with volar locking plate, groups of distal radius fractures are inmobilized with a plaster splint of París for 3 weeks

Splint inmmobilization

Bandage immovilization DEVICE

After internal fixation with volar locking plate, groups of distal radius fractures are inmobilized with compressive bandage for 3 weeks

Bandage immovilization

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Hospital Costa del Sol: lead

Study Sites (2)

Hospital Reina Sofía

Córdoba, 14004, Spain

RECRUITING

Hospital Costa del Sol

Málaga, 29603, Spain

RECRUITING

Related Publications (10)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 21508285 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 18519324 RESULT

• 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.

  PMID: 29256945 RESULT

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Alberto Izquierdo Fernández, Phd

  Hospital Reina Sofía ( Córdoba, Spain)

  STUDY DIRECTOR

Central Study Contacts

Jose Ignacio Miró Jiménez, MD

CONTACT

+34 674501958; ppnxmj89@gmail.com

Alberto Izquierdo Fernández, Phd

CONTACT

+34 667789977; alberto.izquierdo.fer@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patient receive the correspondant treatment based on the order of an aleatory numbers table
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 parallel groups, each one receives one treatment

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 31, 2023
• Study Start: June 1, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)