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

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ClinicalTrials.gov Identifier: NCT03835065
Recruitment Status : Not yet recruiting
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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.


Condition or disease Intervention/treatment Phase
Distal Forearm Fractures Procedure: Closed Reduction Other: Long Arm Fiberglass Cast Other: Short Arm Fiberglass Cast Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long Arm Vs Short Arm Fiberglass Cast for Treatment of Displaced Distal Radius Fractures: A Multi-Center Randomized Control Trial
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Long Arm Fiberglass Cast
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
The primary goal of closed reduction is to maintain appropriate bony alignment and angulation to allow for appropriate healing.

Other: Long Arm Fiberglass Cast
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.

Experimental: Short Arm Fiberglass Cast
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
The primary goal of closed reduction is to maintain appropriate bony alignment and angulation to allow for appropriate healing.

Other: Short Arm Fiberglass Cast
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.




Primary Outcome Measures :
  1. Patients requiring repeat intervention due to loss of alignment [ Time Frame: Up to 7 months ]
    Proportion of patients requiring repeat intervention (cast wedging, recasting, or surgical intervention) following short arm vs long arm cast application.


Secondary Outcome Measures :
  1. Pain assessed by patient reported outcomes - Surveys [ Time Frame: 1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks ]
    Patient Reported Outcome Measures for pain as assessed by PROMIS(Patient-Reported Outcomes Measurement Information System) Pediatric Pain Interference. Highest raw score is 32, lowest raw score is 0, it is interpreted by t-score.

  2. Pain assessed by patient reported outcomes - Surveys [ Time Frame: 1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks ]
    Patient Reported Outcome Measures for pain as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Pain Intensity. Highest raw score is 32, lowest raw score is 0, it is interpreted by t-score.

  3. Comfort assessed by patient reported outcomes - Scale [ Time Frame: 1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks ]
    Patient Reported Outcome Measures for pain as assessed by Visual Analog Scale (VAS) comfort in cast. VAS measures the amount of pain that a patient feels currently and ranges across a continuum from none to an extreme amount of pain. Higher values represent more pain/ worse outcome.

  4. Physical function assessed by patient reported outcomes - Surveys [ Time Frame: 1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks ]
    Patient Reported Outcome Measures for pain as assessed by Pedi-FABS ( Pediatric Functional Activity Brief Scale). Scoring of the Hospital for Special Surgery PediatricFunctional Activity Brief Scale is performed by addingpoints from each question for total possible score range from1 to 30 points. For ''Running'', ''Cutting'', ''Decelerating'',''Pivoting'', ''Duration'', and ''Endurance'', each question is worth 0, 1, 2, 3, or 4 points. Higher values mean that the child is more active.

  5. Physical function assessed by patient reported outcomes - Surveys [ Time Frame: 1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks ]
    Patient Reported Outcome Measures for pain as assessed by PROMIS ( Patient-Reported Outcomes Measurement Information System) Upper Extremity. Within the Pediatric Upper Extremity short form, there are two items (3880R2 and 3881R1) with collapsed response categories. These items have response options scored as 3=With no trouble, 2=With a little trouble, 1=With some trouble, 0=With a lot of trouble, 0=Not able to do.

  6. Physical function assessed by patient reported outcomes - Surveys [ Time Frame: 1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks ]
    Patient Reported Outcome Measures for pain as assessed by UCLA Activity Scale (University of California, Los Angeles Activity Scale). 1 is the lowest raw score, and 10 is the highest raw score. 1= 1: Wholly Inactive, dependent on others, and can not leave residence and 10= 10: Regularly participates in impact sports.

  7. Number of Participants with complications [ Time Frame: 1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks ]
    irritation, compartment syndrome, elbow stiffness, cast saw burns etc



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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835065


Contacts
Contact: Emily R Dodwell, MD MPH FRCSC 212-606-1451 ext 212 dodwelle@hss.edu
Contact: Grace Wang, BA 212-774-2121 ext 212 wangg@hss.edu

Locations
United States, New York
Hospital for Special Surgery Not yet recruiting
New York, New York, United States, 10021
Contact: Emily R Dodwell, MD MPH FRCSC         
Sub-Investigator: Roger Widmann, MD         
Sub-Investigator: Daniel W Green, MD         
Sub-Investigator: John S Blanco, MD         
Sub-Investigator: David M Scher, MD         
Sub-Investigator: Shevaun M Doyle, MD         
Sub-Investigator: Peter D Fabricant, MD         
Sub-Investigator: Ernest Sink, MD         
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Emiyl R Dodwell, MD MPH FRCSC Hospital for Special Surgery, New York

Publications:

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03835065     History of Changes
Other Study ID Numbers: 2017-1930
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital for Special Surgery, New York:
Displaced distal third forearm
Pediatric Patients
Closed reduction
Cast
Patient centered outcome data
RCT

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries
Calpastatin
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action