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| Name | Class |
|---|---|
| Kuopio University Hospital | OTHER |
| Jyväskylä Central Hospital | OTHER |
| Sundsvall Hospital | OTHER |
| Danderyd Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate mobilization after distal radius fracture treated with volar locking plate | Experimental |
| |
| 2 weeks cast immobilization after distal radius fracture treated with volar locking plate | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cast treatment | Other | Dorsal cast placed in OR |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient activity | Patient activity measured with triaxial wrist accelerometer | 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aleksi Reito | Tampere University Hospital | Study Director |
| Laura Kärnä, MD | Tampere University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teemu Karjalainen | Jyväskylä | Finland | ||||
| Kuopio University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36368761 | Derived | Karna L, Launonen AP, Karjalainen T, Luokkala T, Ponkilainen V, Halonen L, Helminen M, Mattila VM, Reito A. LIMPER trials: immediate mobilisation versus 2-week cast immobilisation after distal radius fracture treated with volar locking plate - a study protocol for a prospective, randomised, controlled trial. BMJ Open. 2022 Nov 11;12(11):e064440. doi: 10.1136/bmjopen-2022-064440. |
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Data is available on reasonable request.
After the study has been completed and for 10 years after.
On reasonable request and research plan for IPD use should be provided.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 20, 2025 | Nov 22, 2025 |
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| OTHER |
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| Immediate mobilization | Other | Immediate mobilization postoperatively without casting |
|
| Volar plating | Procedure | Volar plating of distal radius fracture |
|
| 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 |
| Kuopio |
| Finland |
| Laura Kärnä | Tampere | Finland |
| Danderyds Sjukhus | Danderyd | Sweden |
| Sundsvalls sjukhuset | Sundsvall | Sweden |
| SAP_000.pdf |
| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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