Distal Radius Interventions for Fracture Treatment (DRIFT)
Primary Purpose
Fracture Distal Radius
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reduction
Immobilization
Sponsored by
About this trial
This is an interventional treatment trial for Fracture Distal Radius
Eligibility Criteria
Inclusion Criteria:
- Provision of signed and dated informed consent form by parent or legal guardian
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 4-10 years
- Diagnosis of 100% dorsally displaced radius metaphyseal fracture with any or no ulna involvement
- Fracture is less than 5cm from the distal radial growth plate
- Willing to adhere to the immobilization regimen
- Fracture is acute (occurred less than 10 days prior to consent and assignment of treatment arm AND with ability to be taken to operating room (OR) or reduced in the emergency department (ED)
Exclusion Criteria:
- Physeal involvement of fracture
- Presence of open fracture, pathologic fracture, neuromuscular disease, or metabolic disease
- Fracture cannot be treated with acute reduction due to being older than 10 days
- Patient and parents are unable to adhere to procedures or complete follow-up due to insufficient comprehension of consent form or surveys or developmental delay.
Sites / Locations
- Phoenix Children's HospitalRecruiting
- Riley Children'sRecruiting
- Johns Hopkins HospitalRecruiting
- Boston Children's HospitalRecruiting
- Gillette Children's Specialty HealthcareRecruiting
- Montefiore Medical CenterRecruiting
- University of North Carolina at Chapel HillRecruiting
- Cincinnati Children's Hospital Medical CenterRecruiting
- University Hospitals Rainbow Babies & ChildrenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Non-sedated Immobilization
Formal Reduction
Arm Description
Immobilization in a cast without reduction
closed reduction under conscious sedation followed by casting
Outcomes
Primary Outcome Measures
functional and patient reported outcomes
pediatric upper extremity function PROMIS computer adaptive test (PROMIS UE CAT)
Secondary Outcome Measures
PROMIS UE Computerized Adaptive Test (CAT)
functional and patient reported outcomes
Disabilities of the Arm, Shoulder and Hand (DASH) S/PA
functional and patient reported outcomes
PROMIS Pain interference
functional and patient reported outcomes
Wong-Baker Faces Pain scores
functional and patient reported outcomes
Radiographic alignment of bone
imaging
Number of revisions, refractures, re-reductions, and reoperations
clinical outcomes
Estimated unit cost data for hospital and patient charges and costs
cost data
PROMIS Global Health 7+2
functional and patient reported outcomes
Satisfaction questionnaire
functional and patient reported outcomes
Follow-up PROMIS Upper Extremity (UE) CAT
functional and patient reported outcomes
Follow-up Disabilities of the Arm, Shoulder and Hand (DASH) S/PA
functional and patient reported outcomes
Full Information
NCT ID
NCT05131685
First Posted
October 4, 2021
Last Updated
August 30, 2023
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT05131685
Brief Title
Distal Radius Interventions for Fracture Treatment
Acronym
DRIFT
Official Title
Reduction and Nonreduction Treatment of Displaced Pediatric Distal Radius Fractures (Peds-DRIFT Trial - Distal Radius Interventions for Fracture Treatment)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2022 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
September 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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
This protocol describes a multicenter, prospective randomized superiority trial comparing functional outcomes between children treated with sedated reduction versus no formal reduction.
Detailed Description
INTRODUCTION
Distal radius fractures (DRFs) make up 20-25% of all pediatric fractures (Brudvik 2003, Cooper 2004), and are the most common fractures seen in the emergency department in children in the United States. (Naranje 2016)
The available evidence on distal radius fracture (DRF) reduction/non-reduction is based on case series, observational comparisons, and expert opinions. Displaced metaphyseal DRFs have historically been treated with attempts at closed reduction (under conscious sedation or anesthesia). This approach was supported by retrospective studies and consensus opinion that anatomical alignment was necessary for normal function.(Rockwood 2010 text, Bae 2012 JPO) Furthermore, it is unsettling for physicians and families to see bones overlapped on a radiograph when a straightening procedure can be completed in a straightforward fashion. However, simple immobilization without attempted reduction has recently been reported for management of DRFs in children under age 10.(Crawford 2012) This approach is conceptually supported by the fracture's proximity to the distal radial physis and the remaining growth of the child, which provides significant remodeling potential and can allow for improvement of malalignment as the child grows.(Crawford 2010 JBJSAm, Price 1990 JPO) There is a paucity of literature comparing reduced to non-reduced fractures to guide management. No established or standardized guidelines exist for the optimal management of completely displaced fractures. Surveys have identified widely discrepant recommendations and high practice variation for treatments for identical DRF patterns.(Georgiadis 2019 POSNA or JPO 2020) Although these studies provide preliminary data to support clinical management, the studies lack a control population for comparison, are retrospective, lack randomization, have variable follow-up times and have no standard definitions of outcomes. In addition, the studies used radiographic or non-validated outcome measures to make conclusions, limiting their utility in identifying optimal management.
It appears that children may be undergoing unnecessary procedures, sedations, and anesthetics. The use of anesthesia and sedation has recently come into question as studies examine their effects on cognitive development. (Loepke 2013, Flick 2011) There could be a significant cost savings in terms of procedure costs, hospital costs, and lost time from work if non-procedure management is found to be a non-inferior treatment regimen. The physician investigators want to tell patients that they know why they are proposing treatments, the risks and benefits of the treatment, and use evidence to inform these recommendations and the family's decisions. The proposed trial will compare the effectiveness of alignment under sedation/anesthesia with simple immobilization for management of displaced DRFs in children, providing critical data regarding optimal management of this common fracture. Therefore, this study's primary question is: does anatomic reduction under sedation/anesthesia of DRF result in improved patient outcomes at six months compared to immobilization without attempted reduction?
Multiple reasons exist for comparing these treatment strategies for DRF, including: 1) these are the most common treatments for DRF, 2) the strategies are widely divergent (operative vs. non-operative), and 3) there is a large potential to change clinical practice.
QUALITY ASSURANCE AND QUALITY CONTROL
Quality control (QC) procedures will be implemented beginning with the data entry system and data QC checks that will be run on the database will be generated. Any missing data or data anomalies will be communicated to the site(s) for clarification/resolution.
Following written Standard Operating Procedures (SOPs), the monitors will verify that the clinical trial is conducted and data are generated and biological specimens are collected, documented (recorded), and reported in compliance with the protocol, International Conference on Harmonisation Good Clinical Practice (ICH GCP), and applicable regulatory requirements (e.g., Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)).
The investigational site will provide direct access to all trial related sites, source data/documents, and reports for the purpose of monitoring and auditing by the sponsor, and inspection by local and regulatory authorities.
For specific details regarding quality assurance and quality control, please see the data management plan.
DATA HANDLING AND RECORD KEEPING
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site investigator. The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data reported.
Clinical data and patient reported outcomes will be entered into REDCap, a 21 CFR Part 11-compliant data capture system provided by the DCRI. The data system includes password protection and internal quality checks, such as automatic range checks, to identify data that appear inconsistent, incomplete, or inaccurate. Clinical data will be entered directly from the source documents.
SAFETY OVERSIGHT
Safety oversight will be under the direction of a Data and Safety Monitoring Board (DSMB) composed of individuals with the appropriate expertise and knowledge of pediatric orthopaedic surgery usually obtained via an accredited pediatric orthopaedic fellowship. Members of the DSMB should be independent from the study conduct and free of conflict of interest, or measures should be in place to minimize perceived conflict of interest. The DSMB will meet at least semiannually to assess safety data on each arm of the study. The DMSB will operate under the rules of an approved charter that will be written and reviewed at the organizational meeting of the DSMB. At this time, each data element that the DSMB needs to assess will be clearly defined. The DSMB will provide its input to NIAMS.
Statistical Hypotheses:
• Primary Efficacy Endpoint(s):
The null hypothesis is that there is no difference in PROMIS UE (CAT) at 1 year between arms. The alternative hypothesis is that there is a difference between arms.
SAMPLE SIZE DETERMINATION
Sample size calculations were based on detecting a clinically meaningful difference in the Patient Reported Outcomes Measurement Information System (PROMIS) Upper extremity computer adaptive test (CAT) of 4 points. PROMIS measures use a T-score metric with a mean of 50 and standard deviation of 10 in a reference population. A sample size of 133 per am, assuming a two-sided type I error rate of 0.05, will provide 90% power to detect a difference between arms of 4 points.
To conservatively account for 20% lost-to-follow-up or missing data on the primary outcome at 12 months, the investigators have inflated the sample size to 167 per arm, for a total target enrollment of 334.
A blinded sample size re-estimation based on the standard deviation of the primary outcome, after 100 participants have completed the 6 month follow-up, will be performed.
GENERAL APPROACH
Note: Statistical Analyses are described in depth in the Statistical Analysis Plan.
Descriptive statistics will summarize all baseline variables by arm. Specifically, continuous variables will be summarized using mean and standard deviation, for normally distributed variables, and median and IQR, for non-normally distributed variables. Categorical variables will be summarized with frequency and percentages. There will be no formal hypothesis testing for comparison of baseline characteristics between treatment arms.
Primary analyses of the primary outcome at 1 year will be assessed with a two-sided type I error rate of 0.05 for a MCID of 4 points. A false discovery rate (FDR) correction will be applied to analyses of all secondary outcomes to account for multiplicity.
ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S)
Analysis for the primary aim will utilize a mixed effect model for the primary outcome, PROMIS Upper Extremity Function at 12 months, with a fixed effect for treatment arm and a random effect for site. Fixed effects will also include all variables considered in the randomization (site, sex, age), to control for imbalances in both the design and analysis. Incorporation of a random center effect will allow for separation of between site and within site variance components. Distributional assumptions will be assessed and transformations or inclusions of higher order terms may be considered, as appropriate.
ANALYSIS OF THE SECONDARY ENDPOINT(S)
Secondary analyses will employ similar methods for all secondary continuous outcomes. A generalized linear mixed effect model with Poisson distribution and log link will be used for the secondary count outcome, number of revisions, refractures, re-reductions, and reoperations. Distributional assumptions will be assessed, and a dichotomous version may be used instead if appropriate (any revisions, refractures, reductions, and reoperations vs never). Descriptive statistics will be used summarize satisfaction survey by treatment arm. Simple non-parametric test statistics or chi-squared test statistics may be used to compare ordinal and binary variables, respectively.
Exploratory analyses may also consider trajectories of the primary outcome measured over time. Fixed effects for baseline PROMIS Upper Extremity Function, time, treatment arm, and the interaction will be included in a linear mixed effect model with random patient nested in center effects.
A False Discovery Rate (FDR) correction will be applied to all secondary analyses to account for multiplicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture Distal Radius
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
334 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non-sedated Immobilization
Arm Type
Experimental
Arm Description
Immobilization in a cast without reduction
Arm Title
Formal Reduction
Arm Type
Active Comparator
Arm Description
closed reduction under conscious sedation followed by casting
Intervention Type
Procedure
Intervention Name(s)
Reduction
Intervention Description
closed reduction under conscious sedation followed by casting
Intervention Type
Procedure
Intervention Name(s)
Immobilization
Intervention Description
immobilization in cast without reduction
Primary Outcome Measure Information:
Title
functional and patient reported outcomes
Description
pediatric upper extremity function PROMIS computer adaptive test (PROMIS UE CAT)
Time Frame
1 year follow-up
Secondary Outcome Measure Information:
Title
PROMIS UE Computerized Adaptive Test (CAT)
Description
functional and patient reported outcomes
Time Frame
6 weeks and 3, and 6 months
Title
Disabilities of the Arm, Shoulder and Hand (DASH) S/PA
Description
functional and patient reported outcomes
Time Frame
6 weeks and 3, and 6 months
Title
PROMIS Pain interference
Description
functional and patient reported outcomes
Time Frame
6 weeks, 3, 6, and 12 months
Title
Wong-Baker Faces Pain scores
Description
functional and patient reported outcomes
Time Frame
6 weeks, 3, 6, and 12 months
Title
Radiographic alignment of bone
Description
imaging
Time Frame
6 weeks and 3 months
Title
Number of revisions, refractures, re-reductions, and reoperations
Description
clinical outcomes
Time Frame
within 1 year
Title
Estimated unit cost data for hospital and patient charges and costs
Description
cost data
Time Frame
study duration
Title
PROMIS Global Health 7+2
Description
functional and patient reported outcomes
Time Frame
3, 6, 12, 24, and 36 months
Title
Satisfaction questionnaire
Description
functional and patient reported outcomes
Time Frame
3,6, and 12 months
Title
Follow-up PROMIS Upper Extremity (UE) CAT
Description
functional and patient reported outcomes
Time Frame
12, 24 and 36 months
Title
Follow-up Disabilities of the Arm, Shoulder and Hand (DASH) S/PA
Description
functional and patient reported outcomes
Time Frame
12, 24 and 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of signed and dated informed consent form by parent or legal guardian
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 4-10 years
Diagnosis of 100% dorsally displaced radius metaphyseal fracture with any or no ulna involvement
Fracture is less than 5cm from the distal radial growth plate
Willing to adhere to the immobilization regimen
Fracture is acute (occurred less than 10 days prior to consent and assignment of treatment arm AND with ability to be taken to operating room (OR) or reduced in the emergency department (ED)
Exclusion Criteria:
Physeal involvement of fracture
Presence of open fracture, pathologic fracture, neuromuscular disease, or metabolic disease
Fracture cannot be treated with acute reduction due to being older than 10 days
Patient and parents are unable to adhere to procedures or complete follow-up due to insufficient comprehension of consent form or surveys or developmental delay.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie Burgess, PhD
Phone
312-227-6531
Email
jburgess@luriechildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Candace Young, BS
Phone
(312) 227-6427
Email
cstrohbach@luriechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jospeh Janicki, MD
Organizational Affiliation
Ann and Robert H. Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kajol Majhail
Phone
602-933-2712
Email
Kmajhail@phoenixchildrens.com
First Name & Middle Initial & Last Name & Degree
Mohan Belthur, MD
Facility Name
Riley Children's
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Molly Moore
Email
momfreed@iupui.edu
First Name & Middle Initial & Last Name & Degree
Erika Daley, MD
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabrielle Reichard
Email
greicha1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
R. Jay Lee, MD
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Fajardo
Email
maya.fajardo@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Collin May, MD
Facility Name
Gillette Children's Specialty Healthcare
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Price
Phone
651-325-2315
Email
jamienprice@gillettechildrens.com
First Name & Middle Initial & Last Name & Degree
Walter Truong, MD
First Name & Middle Initial & Last Name & Degree
Andrew Georgiadis, MD
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leila Alvandi
Email
lalvandi@montefiore.org
First Name & Middle Initial & Last Name & Degree
Jacob Schulz, MD
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malvika Choudhari
Phone
919-966-9718
Email
malvika_choudhari@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Stuart Leighton Mitchell, MD
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Brthko
Phone
karen.brthko@cchmc.org
First Name & Middle Initial & Last Name & Degree
Wendy Ramalingam, MD
Facility Name
University Hospitals Rainbow Babies & Children
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abigail Schlosser, RN BSN
First Name & Middle Initial & Last Name & Degree
Christina Hardesty
12. IPD Sharing Statement
Plan to Share IPD
No
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Distal Radius Interventions for Fracture Treatment
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