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

Not Applicable

Recruiting

• Conditions: Distal Radius Fracture
• Interventions: Other: Immediate mobilization; Other: Cast treatment; Procedure: Volar plating

• Registration Number: NCT05150925
• Lead Sponsor: Tampere University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-11-26
• Study Start: 2021-12-01
• Study First Posted: 2021-12-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 weeks cast immobilization after distal radius fracture treated with volar locking plate	Volar plating	-
Immediate mobilization after distal radius fracture treated with volar locking plate	Immediate mobilization	-
2 weeks cast immobilization after distal radius fracture treated with volar locking plate	Cast treatment	-
Immediate mobilization after distal radius fracture treated with volar locking plate	Volar plating	-

Primary Outcome Measures

Name	Time	Method
Patient-rated wrist evaluation questionnaire	2 months	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.
Total lenght of the sick leave	12 months	Total number of days of work during the 1 year study period

Secondary Outcome Measures

Name	Time	Method
Patient-rated wrist evaluation questionnaire	12 months	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.
Return to work	12 months	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.
Complications	12 months	Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome
Work capacity	12 months	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.
Visual analogue pain scale	12 months	Overall pain during last 7 days in a scale from 0 to 100 (worst)
Self-perceived working ability	12 months	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).
Patient-acceptable symptom state	12 months	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)?

Trial Locations

Locations (2)

Teemu Karjalainen; 🇫🇮 Jyväskylä, Finland

Laura Kärnä; 🇫🇮 Tampere, Finland