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Four or Six Weeks of Immobilization in the Conservative Treatment of Distal Radius Fractures in Elderly Population?

Primary Purpose

Distal Radius Fracture

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Below elbow cast
Sponsored by
Parc de Salut Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients older than 65 years with a low energy distal radius fracture
  • Intra or extraarticular distal radius fracture (A2, A3, C1, C2)
  • Acceptable primary reduction (dorsal inclination <10º, radial shortening <3mm, articular gap <2mm)

Exclusion criteria:

  • History of ipsilateral fracture
  • Bilateral fracture
  • Open fracture
  • Other concomitant fracture (except ulnar styloid fracture)
  • Fracture AO B
  • Previous surgeries in this area
  • Dementia

Sites / Locations

  • Hospital del MarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

4 week cast

6 week cast

Arm Description

Patients over 65 years old with a distal radius fracture will be treated conservatively with a cast for 4 weeks. Once the immobilization will be removed, the standard rehabilitation protocol of our center used in these fractures will be carried out. The usual clinical and radiological follow-up will be performed at 3, 6 and 12 months.

Patients over 65 years old with a distal radius fracture will be treated conservatively with a cast for 6 weeks. Once the immobilization will be removed, the standard rehabilitation protocol of our center used in these fractures will be carried out. The usual clinical and radiological follow-up will be performed at 3, 6 and 12 months.

Outcomes

Primary Outcome Measures

Patient Rated Wrist Evaluation (PRWE)
The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.
Patient Rated Wrist Evaluation (PRWE)
The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.
Patient Rated Wrist Evaluation (PRWE)
The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.

Secondary Outcome Measures

Quick Disability of Arm and Shoulder (QuickDASH)
It is a questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.
Quick Disability of Arm and Shoulder (QuickDASH)
It is a questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.
Quick Disability of Arm and Shoulder (QuickDASH)
It is a questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.
Visual Analogue Scale (VAS)
is a measuring instrument that tries to measure the amount of pain a patient feels, which is supposed to be a value that oscillates in a continuous between no pain and an extreme amount of pain.
Visual Analogue Scale (VAS)
is a measuring instrument that tries to measure the amount of pain a patient feels, which is supposed to be a value that oscillates in a continuous between no pain and an extreme amount of pain.
Visual Analogue Scale (VAS)
is a measuring instrument that tries to measure the amount of pain a patient feels, which is supposed to be a value that oscillates in a continuous between no pain and an extreme amount of pain.
Range Of Movement (ROM)
Flexion, Extension, radial and ulnar deviation
Range Of Movement (ROM)
Flexion, Extension, radial and ulnar deviation
Range Of Movement (ROM)
Flexion, Extension, radial and ulnar deviation
Complications
Stiffness, delayed and non-union and complex regional pain syndrome (CRPS).

Full Information

First Posted
May 6, 2022
Last Updated
May 6, 2022
Sponsor
Parc de Salut Mar
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1. Study Identification

Unique Protocol Identification Number
NCT05370365
Brief Title
Four or Six Weeks of Immobilization in the Conservative Treatment of Distal Radius Fractures in Elderly Population?
Official Title
Four or Six Weeks of Immobilization in the Conservative Treatment of Distal Radius Fractures in Elderly Population?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
November 6, 2022 (Anticipated)
Study Completion Date
November 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Parc de Salut Mar

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to compare if there are differences in wrist function and pain after a distal radius fracture treated conservatively with immobilization for 4 or 6 weeks in elderly patients after six months of follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective single-blinded randomised clinical trial
Masking
InvestigatorOutcomes Assessor
Masking Description
Data from the demographic data collection and the outcome parameters will be cleaned blindly from the treatment data
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
4 week cast
Arm Type
Experimental
Arm Description
Patients over 65 years old with a distal radius fracture will be treated conservatively with a cast for 4 weeks. Once the immobilization will be removed, the standard rehabilitation protocol of our center used in these fractures will be carried out. The usual clinical and radiological follow-up will be performed at 3, 6 and 12 months.
Arm Title
6 week cast
Arm Type
Experimental
Arm Description
Patients over 65 years old with a distal radius fracture will be treated conservatively with a cast for 6 weeks. Once the immobilization will be removed, the standard rehabilitation protocol of our center used in these fractures will be carried out. The usual clinical and radiological follow-up will be performed at 3, 6 and 12 months.
Intervention Type
Procedure
Intervention Name(s)
Below elbow cast
Intervention Description
Patients will be stay with a below elbow cast for 4 or 6 weeks
Primary Outcome Measure Information:
Title
Patient Rated Wrist Evaluation (PRWE)
Description
The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.
Time Frame
3 months
Title
Patient Rated Wrist Evaluation (PRWE)
Description
The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.
Time Frame
6 months
Title
Patient Rated Wrist Evaluation (PRWE)
Description
The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quick Disability of Arm and Shoulder (QuickDASH)
Description
It is a questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.
Time Frame
3 months
Title
Quick Disability of Arm and Shoulder (QuickDASH)
Description
It is a questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.
Time Frame
6 months
Title
Quick Disability of Arm and Shoulder (QuickDASH)
Description
It is a questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.
Time Frame
1 year
Title
Visual Analogue Scale (VAS)
Description
is a measuring instrument that tries to measure the amount of pain a patient feels, which is supposed to be a value that oscillates in a continuous between no pain and an extreme amount of pain.
Time Frame
3 months
Title
Visual Analogue Scale (VAS)
Description
is a measuring instrument that tries to measure the amount of pain a patient feels, which is supposed to be a value that oscillates in a continuous between no pain and an extreme amount of pain.
Time Frame
6 months
Title
Visual Analogue Scale (VAS)
Description
is a measuring instrument that tries to measure the amount of pain a patient feels, which is supposed to be a value that oscillates in a continuous between no pain and an extreme amount of pain.
Time Frame
1 year
Title
Range Of Movement (ROM)
Description
Flexion, Extension, radial and ulnar deviation
Time Frame
3 months
Title
Range Of Movement (ROM)
Description
Flexion, Extension, radial and ulnar deviation
Time Frame
6 months
Title
Range Of Movement (ROM)
Description
Flexion, Extension, radial and ulnar deviation
Time Frame
1 year
Title
Complications
Description
Stiffness, delayed and non-union and complex regional pain syndrome (CRPS).
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients older than 65 years with a low energy distal radius fracture Intra or extraarticular distal radius fracture (A2, A3, C1, C2) Acceptable primary reduction (dorsal inclination <10º, radial shortening <3mm, articular gap <2mm) Exclusion criteria: History of ipsilateral fracture Bilateral fracture Open fracture Other concomitant fracture (except ulnar styloid fracture) Fracture AO B Previous surgeries in this area Dementia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sala
Phone
0034932484222
Email
asalapujals@psmar.cat
Facility Information:
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08021
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleix Sala Pujals
Phone
0034932484222
Email
asalapujals@psmar.cat

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Four or Six Weeks of Immobilization in the Conservative Treatment of Distal Radius Fractures in Elderly Population?

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