Distal Radial Fractures in Adult Patients: 4 Weeks Versus 6 Weeks of Cast Immobilisation Following Closed Reduction.

Distal Radial Fractures in Adult Patients: 4 Weeks Versus 6 Weeks of Cast Immobilization Following Closed Reduction.

A single-blinded randomized controlled trial is initiated. Four weeks of plaster cast immobilization is compared with six weeks of plaster cast immobilization in adult patients with adequately reduced distal radius fracture. Primary outcome parameters are functional outcomes measured with the Patient Rated Wrist Evaluation after 6 months of follow-up (FU). Secondary outcomes are Disability of Arm, Shoulder and Hand Score after 6 months and one year, 36-Item Short-Form Health Survey after 6 months and one year, functional outcome earlier in Follow up (6 weeks, 12 weeks, 6 months, and one year), range of motion, pain level, and complications: number of re-interventions, secondary displacement, delayed and non-union.

Study Overview

• Status: Not yet recruiting
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Procedure: Below Elbow cast

Detailed Description

This study will be conducted as a prospective single-blinded randomized clinical trial in a level one trauma center serving the southeast of Ireland. In this study, 4 weeks of plaster immobilization will be compared with 6 weeks of plaster immobilization. The methods of this study protocol are comparable to a previously published article comparing 3 weeks of cast immobilization to 5 weeks of cast immobilization in adult patients with non-displaced distal radius fractures. Patients will be treated in a lower arm cast in a neutral position. Following immobilization, treatment will be the same for both groups, in which additional physiotherapy after removal of the cast is advised, and exercises to train wrist function will be given. As extra structured advice programs may cause no extra benefit for the patient, this was not generally prescribed. However, during follow-up visits, patients will be asked if they were treated by a physiotherapist. If this is the case, details on the number of sessions per week and the total number of weeks the patient received physiotherapy, will be collected.

Patients will only be able to participate if closed reduction of the DRF is adequate. The indication for reduction will be set, using the Lidström criteria for misalignment. Patients will only be able to participate in this study if reduction is performed successfully. Successful reduction will be classified as radial shortening <3 mm, dorsal tilt <10° or intra-articular step-off <2 mm, according to the guidelines of the American Academy of Orthopaedic Surgeons.

After providing informed consent, eligible patients will be randomised after 2 weeks when the fracture has proven to be stable. An independent research assistant will perform concealed permuted block randomisation using a computer-generated randomisation schedule after stratification for fracture type, gender, and age. Allocation will be at random in four blocks. To prevent bias, stratification by age (younger and older than 60 years) and gender will be performed . Randomisation between another 2 or 4 weeks cast immobilisation will be performed to complete a total of 4 and 6 weeks of cast immobilisation, respectively. Randomisation will occur after informed consent.

cast removal, number of re-interventions, delayed and non-unions and Complex regional Pain Syndrome (CRPS).

At each FU visit, the research coordinator or research assistant will ascertain patient status (ie, secondary interventions, adverse events/complications, deaths) and will verify the information within medical records. All adverse events will be addressed to the principal investigator. At each FU visit, the patients will be asked to indicate the actual pain level on a VAS. Patients will also be asked if they have any complaints of their treatment and will be asked if they are currently treated by a physical therapist. At each visit from 8 weeks onwards, the range of motion of the wrist will be measured using a goniometer, according to the reference values for joint range of motion published by the American Academy of Orthopaedic Surgeons. In addition, patients will be asked to complete the questionnaires relating to disability. Plain X-rays of the wrist will be made at the time of presentation in the hospital (ED), after 1 and 2 weeks, 4 or 6 weeks, and at the follow-up visit after 8 weeks, 3 months, 6 months, and one year. The X-ray at 6 months will be taken in order to determine the grade of degenerative joint changes. The time to define the presence of a delayed- or non-union will be at 3 or 6 months. The sample size of 44 patients per treatment group is calculated with a power (1-β) of 80% and a type I error (α) of 5%, allowing for 10% dropout. In this study, we decided to include 50 patients per treatment group. To allow a 10% dropout in this study, in total 100 patients will be included.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James Harty, Professor; Phone Number: 00353214921383; Email: jamesharty@me.com

Study Locations

• Ireland
  • Cork, Ireland, T12DFK4
    • Cork University Hospital
    • Contact: Hany Elbardesy, M.Sc., FRCS; Phone Number: +353892106657; Email: elbardecy@i.com
    • Contact: James Harty, Professor; Email: jamesharty@me.com
    • Sub-Investigator: David Morrissey, FRCS
    • Principal Investigator: Hany Elbardesy, FRCS
    • Principal Investigator: Janes Harty, FRCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Primary displaced distal radius fracture
2. age older than 18 years.
3. Adequate closed reduction of the distal radius fracture according to Lidström criteria for misalignment.

Exclusion Criteria:

1. Ipsilateral fractures proximal to the distal radius.
2. Pre-existent abnormalities or functional deficits of the fractured wrist that influences the patient reported function of the wrist.
3. Open fractures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4 Weeks cast immobilisation; Patients with fracture distal radius ( indicated for conservative treatment) will stay in a below-elbow cast for 4 weeks. Following immobilisation, treatment will be the same for both groups, in which additional physiotherapy after removal of the cast is advised and exercises to train wrist function will be given. As extra structured advice programmes may cause no extra benefit for the patient, this was not generally prescribed. However, during FU visits, patients will be asked if they were treated by a physiotherapist. If this is the case, details on the number of sessions per week and the total number of weeks the patient received physiotherapy, will be collected.	Procedure: Below Elbow cast; below-elbow cast ( 4 or 6 weeks )
Experimental: 6 Weeks cast immobilisation; Patients with fracture distal radius ( indicated for conservative treatment) will stay in a below-elbow cast for 6 weeks. Following immobilisation, treatment will be the same for both groups, in which additional physiotherapy after removal of the cast is advised and exercises to train wrist function will be given. As extra structured advice programmes may cause no extra benefit for the patient, this was not generally prescribed. However, during FU visits, patients will be asked if they were treated by a physiotherapist. If this is the case, details on the number of sessions per week and the total number of weeks the patient received physiotherapy, will be collected.	Procedure: Below Elbow cast; below-elbow cast ( 4 or 6 weeks )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Rated Wrist Evaluation (PRWE)	is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living	One year
Patient Rated Wrist Evaluation (PRWE)	is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living	Three months
Patient Rated Wrist Evaluation (PRWE)	is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living	Six months
Quick Disability of Arm and Shoulder (DASH)	is a self-report questionnaire that assesses a person's perceived level of incapacity pertaining to disability of the arm, shoulder, and hand and is based on the 30-item DASH instrument, where each item on the QuickDASH was retained relative to key concepts of upper-limb functioning as well as the selection of the highest ranked items from the original according to their psychometric properties	3 months
Quick Disability of Arm and Shoulder (DASH)	is a self-report questionnaire that assesses a person's perceived level of incapacity pertaining to disability of the arm, shoulder, and hand and is based on the 30-item DASH instrument, where each item on the QuickDASH was retained relative to key concepts of upper-limb functioning as well as the selection of the highest ranked items from the original according to their psychometric properties	6 months
Quick Disability of Arm and Shoulder (DASH)	is a self-report questionnaire that assesses a person's perceived level of incapacity pertaining to disability of the arm, shoulder, and hand and is based on the 30-item DASH instrument, where each item on the QuickDASH was retained relative to key concepts of upper-limb functioning as well as the selection of the highest ranked items from the original according to their psychometric properties	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Movement	Flexion, Extension, radial and ulnar deviation	3 months
Range of Movement	Flexion, Extension, radial and ulnar deviation	6 months
Range of Movement	Flexion, Extension, radial and ulnar deviation	one year
Complications	Stiffness, delayed and non-union and complex regional pain syndrome (CRPS).	one year

Collaborators and Investigators

• Sponsor: Cork University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 20, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: July 24, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 12, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: distal radius fracture, 4 weeks, 6 weeks.
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: ECM 3 (vvv) 09/02/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: July 2022
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No