Back to resultsInmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures
Primary Purpose
Distal Radius Fractures, Internal Fixation; Complications, Mechanical
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Splint inmmobilization
Bandage immovilization
Sponsored by
About this trial
This is an interventional treatment trial for Distal Radius Fractures focused on measuring distal radius fractures, volar plate, internal fixation, Inmobilization
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.).
Sites / Locations
- Hospital Reina SofíaRecruiting
- Hospital Costa del SolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Splint inmmobilization
Bandage immovilization
Arm Description
Distal radius fractures fixed with volar locking plate and immobilized with an antebrachial splint for 3 weeks
Distal radius fractures fixed with volar locking plate and immobilized with a compressive bandage for 3 weeks
Outcomes
Primary Outcome Measures
Pain in Visual Analogue Scale.
Points from 1 to 10. Higher score: worse value. Lower score: better value.
Function in Patient Rated Wrist Evaluation Scale.
Points from 1 to 100. Higher score: worse value. Lower score: better value.
Range Of Motion in Flexion.
Grades from 0 to 70. Higher score: better value. Lower score: worse value.
Range Of Motion in Flexion.
Grades from 0 to 80. Higher score: better value. Lower score: worse value.
Secondary Outcome Measures
Function in Disabilities of Arm, Shoulder and Hand Scale.
Points from 1 to 150. Higher score: worse value. Lower score: better value
Function in Mayo Wrist Score Scale.
Points from 1 to 100. Higher score: worse value. Lower score: better value.
Range of motion in Supination.
Grades from 0 to 90. Higher score: better value. Lower score: worse value.
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.
Number of posoperative Fisiotherapy sessions performed.
Number of sessions per participant from 1 to 100. Higher score: worse value. Lower score: better value.
Time of fracture union in radiographs.
Number of Weeks from 1 to 12. Higher score: worse value. Lower score: better value.
Number of Instability distal radius fracture Criteria per participant.
Number of criteria from 1 to 6. Higher score: worse value. Lower score: better value.
Grades of Dorsal Displacement in fracture.
Grades from -10 to 30 grades. Higher score: worse value. Lower score: better value.
Range of motion in Pronation.
Grades from 0 to 90. Higher score: better value. Lower score: worse value.
Range of motion in Radial Deviation
Grades from 0 to 15. Higher score: better value. Lower score: worse value.
Range of motion in Ulnar deviation.
Grades from 0 to 30. Higher score: better value. Lower score: worse value.
Number of shortening millimeters in fracture.
Number of millimeters from 0-10. Higher score: worse value. Lower score: better value.
Number of ulnar variance millimeters in fracture.
Number of millimeters from -2 to +4. Higher score: worse value. Lower score: better value.
Number of step-off millimeters in fracture.
Number of millimeters from 0 to 4 mm. Higher score: worse value. Lower score: better value.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06019585
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 30, 2026 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Costa del Sol
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fractures, Internal Fixation; Complications, Mechanical
Keywords
distal radius fractures, volar plate, internal fixation, Inmobilization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 parallel groups, each one receives one treatment
Masking
Outcomes Assessor
Masking Description
Patient receive the correspondant treatment based on the order of an aleatory numbers table
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Splint inmmobilization
Arm Type
Active Comparator
Arm Description
Distal radius fractures fixed with volar locking plate and immobilized with an antebrachial splint for 3 weeks
Arm Title
Bandage immovilization
Arm Type
Active Comparator
Arm Description
Distal radius fractures fixed with volar locking plate and immobilized with a compressive bandage for 3 weeks
Intervention Type
Device
Intervention Name(s)
Splint inmmobilization
Intervention Description
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
Intervention Name(s)
Bandage immovilization
Intervention Description
After internal fixation with volar locking plate, groups of distal radius fractures are inmobilized with compressive bandage for 3 weeks
Primary Outcome Measure Information:
Title
Pain in Visual Analogue Scale.
Description
Points from 1 to 10. Higher score: worse value. Lower score: better value.
Time Frame
1 year
Title
Function in Patient Rated Wrist Evaluation Scale.
Description
Points from 1 to 100. Higher score: worse value. Lower score: better value.
Time Frame
1 year
Title
Range Of Motion in Flexion.
Description
Grades from 0 to 70. Higher score: better value. Lower score: worse value.
Time Frame
1 year
Title
Range Of Motion in Flexion.
Description
Grades from 0 to 80. Higher score: better value. Lower score: worse value.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Function in Disabilities of Arm, Shoulder and Hand Scale.
Description
Points from 1 to 150. Higher score: worse value. Lower score: better value
Time Frame
1 year
Title
Function in Mayo Wrist Score Scale.
Description
Points from 1 to 100. Higher score: worse value. Lower score: better value.
Time Frame
1 year
Title
Range of motion in Supination.
Description
Grades from 0 to 90. Higher score: better value. Lower score: worse value.
Time Frame
1 year
Title
Number of participants with posoperative complications.
Description
Number of participants per group that suffer some complication or side effect during the follow-up period. Higher number of complications: worse value.
Time Frame
1 year
Title
Number of posoperative Fisiotherapy sessions performed.
Description
Number of sessions per participant from 1 to 100. Higher score: worse value. Lower score: better value.
Time Frame
1 year
Title
Time of fracture union in radiographs.
Description
Number of Weeks from 1 to 12. Higher score: worse value. Lower score: better value.
Time Frame
12 weeks
Title
Number of Instability distal radius fracture Criteria per participant.
Description
Number of criteria from 1 to 6. Higher score: worse value. Lower score: better value.
Time Frame
1 year
Title
Grades of Dorsal Displacement in fracture.
Description
Grades from -10 to 30 grades. Higher score: worse value. Lower score: better value.
Time Frame
6 weeks
Title
Range of motion in Pronation.
Description
Grades from 0 to 90. Higher score: better value. Lower score: worse value.
Time Frame
1 year
Title
Range of motion in Radial Deviation
Description
Grades from 0 to 15. Higher score: better value. Lower score: worse value.
Time Frame
1 year
Title
Range of motion in Ulnar deviation.
Description
Grades from 0 to 30. Higher score: better value. Lower score: worse value.
Time Frame
1 year
Title
Number of shortening millimeters in fracture.
Description
Number of millimeters from 0-10. Higher score: worse value. Lower score: better value.
Time Frame
6 weeks
Title
Number of ulnar variance millimeters in fracture.
Description
Number of millimeters from -2 to +4. Higher score: worse value. Lower score: better value.
Time Frame
6 weeks
Title
Number of step-off millimeters in fracture.
Description
Number of millimeters from 0 to 4 mm. Higher score: worse value. Lower score: better value.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Ignacio Miró Jiménez, MD
Phone
+34 674501958
Email
ppnxmj89@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alberto Izquierdo Fernández, Phd
Phone
+34 667789977
Email
alberto.izquierdo.fer@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Izquierdo Fernández, Phd
Organizational Affiliation
Hospital Reina Sofía ( Córdoba, Spain)
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Costa del Sol
City
Málaga
ZIP/Postal Code
29603
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Rivas, Phd
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31579555
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.
Results Reference
result
PubMed Identifier
28428911
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.
Results Reference
result
PubMed Identifier
35186419
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.
Results Reference
result
PubMed Identifier
25748659
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.
Results Reference
result
PubMed Identifier
21508285
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.
Results Reference
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PubMed Identifier
24508093
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.
Results Reference
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PubMed Identifier
23770202
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.
Results Reference
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PubMed Identifier
25157038
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.
Results Reference
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PubMed Identifier
18519324
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.
Results Reference
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PubMed Identifier
29256945
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.
Results Reference
result
Learn more about this trial
Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures
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