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Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures

NCT ID: NCT06019585

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2026-12-30

Brief Summary

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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

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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.

Conditions

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Distal Radius Fractures Internal Fixation; Complications, Mechanical

Keywords

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distal radius fractures volar plate internal fixation Inmobilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 parallel groups, each one receives one treatment
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Patient receive the correspondant treatment based on the order of an aleatory numbers table

Study Groups

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Splint inmmobilization

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

Group Type ACTIVE_COMPARATOR

Splint inmmobilization

Intervention Type DEVICE

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

Bandage immovilization

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

Group Type ACTIVE_COMPARATOR

Bandage immovilization

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Bandage immovilization

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

Intervention Type DEVICE

Eligibility Criteria

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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.).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Costa del Sol

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alberto Izquierdo Fernández, Phd

Role: STUDY_DIRECTOR

Hospital Reina Sofía ( Córdoba, Spain)

Locations

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Hospital Reina Sofía

Córdoba, , Spain

Site Status RECRUITING

Hospital Costa del Sol

Málaga, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Jose Ignacio Miró Jiménez, MD

Role: CONTACT

Phone: +34 674501958

Email: [email protected]

Alberto Izquierdo Fernández, Phd

Role: CONTACT

Phone: +34 667789977

Email: [email protected]

References

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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.

Reference Type RESULT
PMID: 31579555 (View on PubMed)

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.

Reference Type RESULT
PMID: 28428911 (View on PubMed)

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.

Reference Type RESULT
PMID: 35186419 (View on PubMed)

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.

Reference Type RESULT
PMID: 25748659 (View on PubMed)

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.

Reference Type RESULT
PMID: 21508285 (View on PubMed)

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.

Reference Type RESULT
PMID: 24508093 (View on PubMed)

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.

Reference Type RESULT
PMID: 23770202 (View on PubMed)

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.

Reference Type RESULT
PMID: 25157038 (View on PubMed)

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.

Reference Type RESULT
PMID: 18519324 (View on PubMed)

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.

Reference Type RESULT
PMID: 29256945 (View on PubMed)

Other Identifiers

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003may21PIInmovilizacionfxd

Identifier Type: -

Identifier Source: org_study_id