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Distal Radius FracturesNCT06019585

Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures

A study testing Splint inmmobilization and Bandage immovilization in people with Distal Radius Fractures and Internal Fixation; Complications, Mechanical, run by Hospital Costa del Sol at 2 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Splint inmmobilization and Bandage immovilization
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesSpain
Study dates
1 Jun 2021to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.).

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jose Ignacio Miró Jiménez, MD contact

+34 674501958

ppnxmj89@gmail.com

Alberto Izquierdo Fernández, Phd contact

+34 667789977

alberto.izquierdo.fer@hotmail.com

Spain2 sites, 2 recruiting

  • Hospital Reina Sofía

    Córdoba, 14004

    Recruiting

  • Hospital Costa del Sol

    Málaga, 29603

    Francisco Rivas, Phd

    Recruiting

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Splint inmmobilization, Bandage immovilization
Keywords
distal radius fractures, volar plate, internal fixation, Inmobilization
Medical subject headings
Wrist Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Splint inmmobilizationDevice

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

  • Bandage immovilizationDevice

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

Study groups in NCT06019585
Study groupRoleWhat they receive
Splint inmmobilizationActive comparatorDistal radius fractures fixed with volar locking plate and immobilized with an antebrachial splint for 3 weeks
Receives: Device: Splint inmmobilization
Bandage immovilizationActive comparatorDistal radius fractures fixed with volar locking plate and immobilized with a compressive bandage for 3 weeks
Receives: Device: Bandage immovilization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain in Visual Analogue Scale.

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

    Measured: 1 year

  2. Function in Patient Rated Wrist Evaluation Scale.

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

    Measured: 1 year

  3. Range Of Motion in Flexion.

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

    Measured: 1 year

  4. Range Of Motion in Flexion.

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

    Measured: 1 year

Secondary outcomes (14)

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

    Points from 1 to 150. Higher score: worse value. Lower score: better value

    Measured: 1 year

  2. Function in Mayo Wrist Score Scale.

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

    Measured: 1 year

  3. Range of motion in Supination.

    Grades from 0 to 90. Higher score: better value. Lower score: worse value.

    Measured: 1 year

  4. Number of participants with posoperative complications.

    Number of participants per group that suffer some complication or side effect during the follow-up period. Higher number of complications: worse value.

    Measured: 1 year

  5. Number of posoperative Fisiotherapy sessions performed.

    Number of sessions per participant from 1 to 100. Higher score: worse value. Lower score: better value.

    Measured: 1 year

  6. Time of fracture union in radiographs.

    Number of Weeks from 1 to 12. Higher score: worse value. Lower score: better value.

    Measured: 12 weeks

  7. Number of Instability distal radius fracture Criteria per participant.

    Number of criteria from 1 to 6. Higher score: worse value. Lower score: better value.

    Measured: 1 year

  8. Grades of Dorsal Displacement in fracture.

    Grades from -10 to 30 grades. Higher score: worse value. Lower score: better value.

    Measured: 6 weeks

  9. Range of motion in Pronation.

    Grades from 0 to 90. Higher score: better value. Lower score: worse value.

    Measured: 1 year

  10. Range of motion in Radial Deviation

    Grades from 0 to 15. Higher score: better value. Lower score: worse value.

    Measured: 1 year

  11. Range of motion in Ulnar deviation.

    Grades from 0 to 30. Higher score: better value. Lower score: worse value.

    Measured: 1 year

  12. Number of shortening millimeters in fracture.

    Number of millimeters from 0-10. Higher score: worse value. Lower score: better value.

    Measured: 6 weeks

  13. Number of ulnar variance millimeters in fracture.

    Number of millimeters from -2 to +4. Higher score: worse value. Lower score: better value.

    Measured: 6 weeks

  14. Number of step-off millimeters in fracture.

    Number of millimeters from 0 to 4 mm. Higher score: worse value. Lower score: better value.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2023
  2. Study start1 Jun 2021
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
2 parallel groups, each one receives one treatment
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06019585
Sponsor's protocol ID
003may21PIInmovilizacionfxd
Status last verified
Aug 2023
First submitted
24 Jul 2023
Last updated
31 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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: 10.2106/JBJS.938ebo. No abstract available.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 25157038

  • 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.

    PubMed 18519324

  • 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.

    PubMed 29256945

Questions about this trial

What is this clinical trial studying?

A study testing Splint inmmobilization and Bandage immovilization in people with Distal Radius Fractures and Internal Fixation; Complications, Mechanical, run by Hospital Costa del Sol at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jose Ignacio Miró Jiménez, MD (+34 674501958, ppnxmj89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain in Visual Analogue Scale. (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06019585, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.

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