Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures

Distal Radius Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06019585
• Other study ID #: 003may21PIInmovilizacionfxd
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 30, 2026

Study information

• Verified date: August 2023
• Source: Hospital Costa del Sol
• Contact: Jose Ignacio Miró Jiménez, MD
• Phone: +34 674501958
• Email: ppnxmj89[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Distal Radius Fractures
• Fractures, Bone
• Radius Fractures
• Wrist Fractures

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Reina Sofía	Córdoba
Spain	Hospital Costa del Sol	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Costa del Sol

Country where clinical trial is conducted

Spain, 

References & 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. — View 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- — View 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. — View 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. — View 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 Orthop — View 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. — View 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. — View 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. do — View 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;12:21514593 — View 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. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain in Visual Analogue Scale.	Points from 1 to 10. Higher score: worse value. Lower score: better value.	1 year
Primary	Function in Patient Rated Wrist Evaluation Scale.	Points from 1 to 100. Higher score: worse value. Lower score: better value.	1 year
Primary	Range Of Motion in Flexion.	Grades from 0 to 70. Higher score: better value. Lower score: worse value.	1 year
Primary	Range Of Motion in Flexion.	Grades from 0 to 80. Higher score: better value. Lower score: worse value.	1 year
Secondary	Function in Disabilities of Arm, Shoulder and Hand Scale.	Points from 1 to 150. Higher score: worse value. Lower score: better value	1 year
Secondary	Function in Mayo Wrist Score Scale.	Points from 1 to 100. Higher score: worse value. Lower score: better value.	1 year
Secondary	Range of motion in Supination.	Grades from 0 to 90. Higher score: better value. Lower score: worse value.	1 year
Secondary	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.	1 year
Secondary	Number of posoperative Fisiotherapy sessions performed.	Number of sessions per participant from 1 to 100. Higher score: worse value. Lower score: better value.	1 year
Secondary	Time of fracture union in radiographs.	Number of Weeks from 1 to 12. Higher score: worse value. Lower score: better value.	12 weeks
Secondary	Number of Instability distal radius fracture Criteria per participant.	Number of criteria from 1 to 6. Higher score: worse value. Lower score: better value.	1 year
Secondary	Grades of Dorsal Displacement in fracture.	Grades from -10 to 30 grades. Higher score: worse value. Lower score: better value.	6 weeks
Secondary	Range of motion in Pronation.	Grades from 0 to 90. Higher score: better value. Lower score: worse value.	1 year
Secondary	Range of motion in Radial Deviation	Grades from 0 to 15. Higher score: better value. Lower score: worse value.	1 year
Secondary	Range of motion in Ulnar deviation.	Grades from 0 to 30. Higher score: better value. Lower score: worse value.	1 year
Secondary	Number of shortening millimeters in fracture.	Number of millimeters from 0-10. Higher score: worse value. Lower score: better value.	6 weeks
Secondary	Number of ulnar variance millimeters in fracture.	Number of millimeters from -2 to +4. Higher score: worse value. Lower score: better value.	6 weeks
Secondary	Number of step-off millimeters in fracture.	Number of millimeters from 0 to 4 mm. Higher score: worse value. Lower score: better value.	6 weeks