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

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05370365
• Other study ID #: 4/6
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: November 6, 2023

Study information

• Verified date: May 2022
• Source: Parc de Salut Mar
• Contact: Sala
• Phone: 0034932484222
• Email: asalapujals[@]psmar.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: November 6, 2023
• Est. primary completion date: November 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Procedure:
• Below elbow cast
Patients will be stay with a below elbow cast for 4 or 6 weeks

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Rated Wrist Evaluation (PRWE)	The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.	3 months
Primary	Patient Rated Wrist Evaluation (PRWE)	The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.	6 months
Primary	Patient Rated Wrist Evaluation (PRWE)	The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.	1 year
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	1 year
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	1 year
Secondary	Range Of Movement (ROM)	Flexion, Extension, radial and ulnar deviation	3 months
Secondary	Range Of Movement (ROM)	Flexion, Extension, radial and ulnar deviation	6 months
Secondary	Range Of Movement (ROM)	Flexion, Extension, radial and ulnar deviation	1 year
Secondary	Complications	Stiffness, delayed and non-union and complex regional pain syndrome (CRPS).	1 year