Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate

Distal Radius Fracture Clinical Trial

— LIMPER-DRF  

Official title:

Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate - a Study Protocol for a Prospective, Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05150925
• Other study ID #: R21111
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2022
• Source: Tampere University Hospital
• Contact: Laura Kärnä, MD
• Phone: +3583311611
• Email: laura.karna[@]pshp.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to analyze total lenght of the sick leace and functional outcome (PRWE) at 2 months between 2 weeks casting and immediate mobilization following volar plating for a DRF.

Description:

This study is a prospective, randomized, controlled trial. The aim of this study will be to compare the early postoperative outcomes of the patients enrolled in the early mobilization with those patients in post-operative 2-week casting following volar plating for a DRF. Co-primary outcome in this study will be the total lenght of sick leave and Patient-Rated Wrist Evaluation (PRWE) 2 months after the operation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Intra- or extra articular DRF (Colles, Smith, Volar barton)
• operative treatment justified

Exclusion Criteria:

• Refusal to participate in the study
• Open fracture with a severity greater than Gustilo grade 1
• Patient aged less than 18 or over 65
• Patient does not understand written or spoken guidance in local languages
• Pathological fracture
• Previous fracture in the same wrist or forearm in the last 10 years, that has led to impairment of function
• Ipsilateral fracture in upper extremity
• Associated fractures of the ulna (except fractures of the PSU)
• Polytrauma

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Other:
• Cast treatment
Dorsal cast placed in OR
• Immediate mobilization
Immediate mobilization postoperatively without casting

Procedure:
• Volar plating
Volar plating of distal radius fracture

Locations

Country	Name	City	State
Finland	Teemu Karjalainen	Jyväskylä
Finland	Laura Kärnä	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient activity	Patient activity measured with triaxial wrist accelerometer	4 weeks
Primary	Patient-rated wrist evaluation questionnaire	The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities.	2 months
Primary	Total lenght of the sick leave	Total number of days of work during the 1 year study period	12 months
Secondary	Patient-rated wrist evaluation questionnaire	The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities.	4 weeks
Secondary	Patient-rated wrist evaluation questionnaire	The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities.	6 months
Secondary	Patient-rated wrist evaluation questionnaire	The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities.	12 months
Secondary	Return to work	Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work.	4 weeks
Secondary	Return to work	Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work.	2 months
Secondary	Return to work	Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work.	6 months
Secondary	Return to work	Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work.	12 months
Secondary	Complications	Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome	4 weeks
Secondary	Complications	Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome	2 months
Secondary	Complications	Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome	6 months
Secondary	Complications	Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome	12 months
Secondary	Self-perceived working ability	Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled).	4 weeks
Secondary	Self-perceived working ability	Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled).	2 months
Secondary	Self-perceived working ability	Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled).	6 months
Secondary	Self-perceived working ability	Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled).	12 months
Secondary	Visual analogue pain scale	Overall pain during last 7 days in a scale from 0 to 100 (worst)	4 weeks
Secondary	Visual analogue pain scale	Overall pain during last 7 days in a scale from 0 to 100 (worst)	2 months
Secondary	Visual analogue pain scale	Overall pain during last 7 days in a scale from 0 to 100 (worst)	6 months
Secondary	Visual analogue pain scale	Overall pain during last 7 days in a scale from 0 to 100 (worst)	12 months
Secondary	Patient-acceptable symptom state	Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)?	2 months
Secondary	Patient-acceptable symptom state	Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)?	6 months
Secondary	Patient-acceptable symptom state	Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)?	12 months
Secondary	Work capacity	The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best.	4 weeks
Secondary	Work capacity	The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best.	2 months
Secondary	Work capacity	The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best.	6 months
Secondary	Work capacity	The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best.	12 months