Above-versus Below-elbow Casting for Conservative Treatment of Distal Radius Fractures

NCT03126175 | Completed DMC

• 1 other identifier: Above X below-elbow casting
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

For the non-surgical treatment of distal radius fractures in adults a variety cast options are available, including or not the elbow joint. The literature is inconclusive regarding the need to immobilize the elbow joint after reduction of the distal radius fracture.This study was undertaken to evaluate the best method of immobilization between the above and below-elbow cast groups at the end of 6 months of follow-up.

Conditions

Distal Radius Fracture

Keywords

conservative treatment, treatment outcome

Outcome Measures

Primary Outcomes (1)

• maintenance of reduction by evaluation of radiographic parameters (wrist radiographs).

  Posteroanterior and lateral x-rays of the wrist to measure radiographic parameters to determine maintenance of reduction will be done every follow up visit. Measurements of the alignment will be made on the radiographs with a marker, straight edge, and protractor. The radiographic measurement technique will be standardized, and repeatability testing demonstrated by a complete blinded assessor. All radiographs will be reviewed by one of the four authors.

  One, two, three, four, six, eight, twelve and twenty four weeks after fracture reduction(radiographs).

Secondary Outcomes (4)

• DASH questionnaire

  Two, six , eight, twelve and twenty four weeks

• Patient Rated Wrist Evaluation (PRWE)

  Eight, twelve and twenty four weeks.

• Pain (VAS - "Visual Analogue Pain Scale").

  one, two, three, four, six, eight, twelve and twenty four weeks after fracture reduction

• Objective functional evaluation (goniometry and dynamometry)

  Six, eight, twelve and twenty four weeks follow up visit.

Study Arms (2)

Above elbow immobilization

ACTIVE COMPARATOR

Above elbow immobililization with short radial splint that will be performed with 20cm wide gypsum cut to fit the thumb. The splint will be applied to the radial aspect of the wrist covering the volar and dorsal portion of the radius to the elbow. Additional splint with a 15cm width splint on the ulnar aspect of the forearm that begins at the middle of the forearm and extends into the armpit.

Device: Above elbow immobilization

Below elbow immobilization

EXPERIMENTAL

Below elbow immobilization with exclusively short radial splint that will be performed with 20cm wide gypsum cut to fit the thumb. The splint will be applied to the radial aspect of the wrist covering the volar and dorsal portion of the radius to the elbow.

Device: Below elbow immobilization

Interventions

Below elbow immobilization DEVICE

20cm wide gypsum in the forearm cut to fit the thumb.

Also known as: Plaster immobilization with elbow free (Below elbow)

Below elbow immobilization

Above elbow immobilization DEVICE

20cm wide gypsum in the forearm cut to fit the thumb associated a elbow splint made with a 15cm width on the ulnar aspect of the forearm that begins at the middle of the forearm and extends into the armpit.

Also known as: Plater immobilization including elbow (Above elbow)

Above elbow immobilization

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with growth plate closured, both gender, with closed acute displaced distal radius fracture (up to 1 week), associated or not with the ulnar styloid fractures with no other fractures, which may be closed reduced after intravenous anesthesia. No previous fractures to the ipsilateral or contralateral forearm.
• Displaced and reducible fractures (after venous anesthesia) classified by AO as type A2, A3, C1, C2 and C3.

You may not qualify if:

• Open fractures.
• Vascular ou neurological compromise

Sponsors & Collaborators

• Hospital Dr. Fernando Mauro Pires da Rocha: lead
• Federal University of São Paulo: collaborator

Study Sites (1)

Hospital Municipal Dr. Fernando Mauro Pires da Rocha

São Paulo, São Paulo, 05835-005, Brazil

Location

Related Publications (7)

• Bunger C, Solund K, Rasmussen P. Early results after Colles' fracture: functional bracing in supination vs dorsal plaster immobilization. Arch Orthop Trauma Surg (1978). 1984;103(4):251-6. doi: 10.1007/BF00387330.

  PMID: 6391415 BACKGROUND

• Bong MR, Egol KA, Leibman M, Koval KJ. A comparison of immediate postreduction splinting constructs for controlling initial displacement of fractures of the distal radius: a prospective randomized study of long-arm versus short-arm splinting. J Hand Surg Am. 2006 May-Jun;31(5):766-70. doi: 10.1016/j.jhsa.2006.01.016.

  PMID: 16713840 BACKGROUND

• Stewart HD, Innes AR, Burke FD. Functional cast-bracing for Colles' fractures. A comparison between cast-bracing and conventional plaster casts. J Bone Joint Surg Br. 1984 Nov;66(5):749-53. doi: 10.1302/0301-620X.66B5.6389558.

  PMID: 6389558 BACKGROUND

• Bohm ER, Bubbar V, Yong Hing K, Dzus A. Above and below-the-elbow plaster casts for distal forearm fractures in children. A randomized controlled trial. J Bone Joint Surg Am. 2006 Jan;88(1):1-8. doi: 10.2106/JBJS.E.00320.

  PMID: 16391243 BACKGROUND

• Pool C. Colles's fracture. A prospective study of treatment. J Bone Joint Surg Br. 1973 Aug;55(3):540-4. No abstract available.

  PMID: 4125714 BACKGROUND

• Sarmiento A, Pratt GW, Berry NC, Sinclair WF. Colles' fractures. Functional bracing in supination. J Bone Joint Surg Am. 1975 Apr;57(3):311-7.

  PMID: 1123382 RESULT

• Okamura A, de Mendonca GM, Raduan Neto J, de Moraes VY, Faloppa F, Belloti JC. Above-versus below-elbow casting for conservative treatment of distal radius fractures: a randomized controlled trial and study protocol. BMC Musculoskelet Disord. 2018 Mar 27;19(1):92. doi: 10.1186/s12891-018-2007-9.

  PMID: 29587687 DERIVED

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• João Carlos Belloti, PhD

  Federal University of São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 24, 2017
• Study Start: April 2, 2018
• Primary Completion: December 9, 2019
• Study Completion: December 9, 2019
• Last Updated: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data of study protocol is already available. doi: 10.1186/s12891-018-2007-9
• Access Criteria: open

Locations

BR (1)