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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Distal Radius Fracture

Intervention / Treatment
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* Other: Cast treatment
* Other: Immediate mobilization
* Procedure: Volar plating


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate mobilization after distal radius fracture treated with volar locking plate<br> | Other: Immediate mobilization<br>* Immediate mobilization postoperatively without casting<br>Procedure: Volar plating<br>* Volar plating of distal radius fracture<br>|
| Active Comparator: 2 weeks cast immobilization after distal radius fracture treated with volar locking plate<br> | Other: Cast treatment<br>* Dorsal cast placed in OR<br>Procedure: Volar plating<br>* Volar plating of distal radius fracture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Total lenght of the sick leave | Total number of days of work during the 1 year study period | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Complications | Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome | 4 weeks | 
| Complications | Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome | 2 months | 
| Complications | Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome | 6 months | 
| Complications | Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome | 12 months | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Visual analogue pain scale | Overall pain during last 7 days in a scale from 0 to 100 (worst) | 4 weeks | 
| Visual analogue pain scale | Overall pain during last 7 days in a scale from 0 to 100 (worst) | 2 months | 
| Visual analogue pain scale | Overall pain during last 7 days in a scale from 0 to 100 (worst) | 6 months | 
| Visual analogue pain scale | Overall pain during last 7 days in a scale from 0 to 100 (worst) | 12 months | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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volar plating, surgery, distal radius fracture