Distal Radius Fracture
Conditions
Keywords
distal radius fracture, volar plating, surgery
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.
Interventions
OTHERCast treatment
Dorsal cast placed in OR
Immediate mobilization postoperatively without casting
PROCEDUREVolar plating
Volar plating of distal radius fracture
Sponsors
Tampere University Hospital
Kuopio University Hospital
Jyväskylä Central Hospital
Sundsvall Hospital
Danderyd Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Patient-rated wrist evaluation questionnaire | 4 weeks | 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 | 4 weeks | 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 | 4 weeks | Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
| Self-perceived working ability | 4 weeks | 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). |
| Visual analogue pain scale | 4 weeks | Overall pain during last 7 days in a scale from 0 to 100 (worst) |
| Patient-acceptable symptom state | 2 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)? |
| Work capacity | 4 weeks | 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. |
Countries
Finland, Sweden
Contacts
STUDY_DIRECTORAleksi Reito
Tampere University Hospital
PRINCIPAL_INVESTIGATORLaura Kärnä, MD
Tampere University Hospital
Outcome results
None listed