Long Arm Vs Short Arm Fiberglass Cast for Treatment of Displaced Distal Radius Fractures

NCT03835065 | Withdrawn

• 1 other identifier: 2017-1930
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to determine by multicenter randomized controlled trial whether short arm fiberglass casts are as effective as long arm casts for immobilizing displaced pediatric distal third forearm fractures that have undergone closed reduction. The primary outcome is loss of reduction requiring cast wedging, recasting, repeat reduction, or surgical intervention. Secondary outcomes will include Patient Reported Outcome Measures for physical function, such as Pedi-FABS, PROMIS (Patient Reported Outcomes Measurement Information System) Upper Extremities , and UCLA (University of California Los Angelos) Activity Scale, and pain/comfort levels,such as PROMIS Pediatric Pain Interference, PROMIS Pediatric Pain Intensity, and VAS ( Visual Analogue Scale) comfort in cast. In addition, secondary outcomes include complications (skin irritation, compartment syndrome, elbow stiffness, cast saw burns etc). The investigators will assess potential risk factors for loss of reduction including initial displacement, level of fracture (physeal, metaphyseal, meta-diaphyseal), initial translation, initial angulation, age, sex, cast index, padding index, adequacy of initial reduction, and provider level of training.

Conditions

Distal Forearm Fractures

Keywords

Displaced distal third forearm; Pediatric Patients; Closed reduction; Cast; Patient centered outcome data; RCT

Outcome Measures

Primary Outcomes (1)

• Patients requiring repeat intervention due to loss of alignment

  Proportion of patients requiring repeat intervention (cast wedging, recasting, or surgical intervention) following short arm vs long arm cast application.

  Up to 7 months

Secondary Outcomes (7)

• Pain assessed by patient reported outcomes - Surveys

  1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks

• Pain assessed by patient reported outcomes - Surveys

  1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks

• Comfort assessed by patient reported outcomes - Scale

  1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks

• Physical function assessed by patient reported outcomes - Surveys

  1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks

• Physical function assessed by patient reported outcomes - Surveys

  1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks

Study Arms (2)

Long Arm Fiberglass Cast

ACTIVE COMPARATOR

Conscious sedation will be provided to patient while the reduction is performed by a cast trained orthopedic resident using standard techniques under fluoroscopic guidance. The arm will be held by an assistant or finger traps in the absence thereof. The arm will not be suspended until after the manipulation is performed. A stockingette and webril will first be applied, after which the short arm fiberglass portion of the cast will be applied. After short arm casting has been appropriately placed, randomization group will be revealed. Casting will be extended to the shoulder joint if the patient is assigned to the long arm cast group. The mold will then be applied and cast construct will be bivalved and taped.

Procedure: Closed Reduction; Other: Long Arm Fiberglass Cast

Short Arm Fiberglass Cast

EXPERIMENTAL

Conscious sedation will be provided to patient while the reduction is performed by a cast trained orthopedic resident using standard techniques under fluoroscopic guidance. The arm will be held by an assistant or finger traps in the absence thereof. The arm will not be suspended until after the manipulation is performed. A stockingette and webril will first be applied, after which the short arm fiberglass portion of the cast will be applied. After short arm casting has been appropriately placed, randomization group will be revealed. Casting will be complete at this point if the patient is assigned to the short arm cast group. The mold will then be applied and cast construct will be bivalved and taped.

Procedure: Closed Reduction; Other: Short Arm Fiberglass Cast

Interventions

Closed Reduction PROCEDURE

The primary goal of closed reduction is to maintain appropriate bony alignment and angulation to allow for appropriate healing.

Long Arm Fiberglass Cast; Short Arm Fiberglass Cast

Long Arm Fiberglass Cast OTHER

A stockingette and webril will first be applied, after which the short arm fiberglass portion of the cast will be applied. After short arm casting has been appropriately placed, randomization group will be revealed. Casting will be extended to the shoulder joint if the patient is assigned to the long arm cast group. The mold will then be applied and cast construct will be bivalved and taped.

Long Arm Fiberglass Cast

Short Arm Fiberglass Cast OTHER

A stockingette and webril will first be applied, after which the short arm fiberglass portion of the cast will be applied. After short arm casting has been appropriately placed, randomization group will be revealed. Casting will be complete at this point if the patient is assigned to the short arm cast group. The mold will then be applied and cast construct will be bivalved and taped.

Short Arm Fiberglass Cast

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients 4-12 years of age
• Displaced distal third forearm fracture (physeal, metaphyseal, meta-diaphyseal) requiring closed reduction
• Displacement must be: For children 4-9: angulation \>30 degrees and/or 100% translation on either AP (anteroposterior) or lateral view. For children 10-12: angulation \> 15 degrees and/or \>50% translation on either AP or lateral view

You may not qualify if:

• Patients undergoing additional orthopedic procedures at the time closed reduction of distal arm fracture
• Patient with a presenting open fracture
• A known pathologic fracture
• Patient with a refracture through pre-existing fracture lines
• Patients with compartment syndrome or neuropathy

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (9)

• Nellans KW, Kowalski E, Chung KC. The epidemiology of distal radius fractures. Hand Clin. 2012 May;28(2):113-25. doi: 10.1016/j.hcl.2012.02.001. Epub 2012 Apr 14.

  PMID: 22554654 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

• Webb GR, Galpin RD, Armstrong DG. Comparison of short and long arm plaster casts for displaced fractures in the distal third of the forearm in children. J Bone Joint Surg Am. 2006 Jan;88(1):9-17. doi: 10.2106/JBJS.E.00131.

  PMID: 16391244 BACKGROUND

• Paneru SR, Rijal R, Shrestha BP, Nepal P, Khanal GP, Karn NK, Singh MP, Rai P. Randomized controlled trial comparing above- and below-elbow plaster casts for distal forearm fractures in children. J Child Orthop. 2010 Jun;4(3):233-7. doi: 10.1007/s11832-010-0250-1. Epub 2010 Mar 17.

  PMID: 21629372 BACKGROUND

• Colaris JW, Allema JH, Biter LU, Reijman M, van de Ven CP, de Vries MR, Bloem RM, Kerver AJ, Verhaar JA. Conversion to below-elbow cast after 3 weeks is safe for diaphyseal both-bone forearm fractures in children. Acta Orthop. 2013 Oct;84(5):489-94. doi: 10.3109/17453674.2013.850010. Epub 2013 Oct 31.

  PMID: 24171685 BACKGROUND

• Worlock P, Stower M. Fracture patterns in Nottingham children. J Pediatr Orthop. 1986 Nov-Dec;6(6):656-60. doi: 10.1097/01241398-198611000-00003.

  PMID: 3793885 BACKGROUND

• Webb JE, Lewallen LW, Christophersen C, Krych AJ, McIntosh AL. Clinical outcome of internal fixation of unstable juvenile osteochondritis dissecans lesions of the knee. Orthopedics. 2013 Nov;36(11):e1444-9. doi: 10.3928/01477447-20131021-30.

  PMID: 24200451 BACKGROUND

• Kamat AS, Pierse N, Devane P, Mutimer J, Horne G. Redefining the cast index: the optimum technique to reduce redisplacement in pediatric distal forearm fractures. J Pediatr Orthop. 2012 Dec;32(8):787-91. doi: 10.1097/BPO.0b013e318272474d.

  PMID: 23147621 BACKGROUND

• Chess DG, Hyndman JC, Leahey JL, Brown DC, Sinclair AM. Short arm plaster cast for distal pediatric forearm fractures. J Pediatr Orthop. 1994 Mar-Apr;14(2):211-3. doi: 10.1097/01241398-199403000-00015.

  PMID: 8188836 BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Interventions

Closed Fracture Reduction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics

Study Officials

• Emiyl R Dodwell, MD MPH FRCSC

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: February 8, 2019
• Study Start: February 12, 2019
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: March 24, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)