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Aim of our study is to compare immediate full weight-bearing and partial weight-bearing for 6 weeks after a tibial shaft fracture treated with intramedullary nailing. Co-primary outcome is return to work and physical component scale in the SF-36 questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full weight-bearing | Experimental | Full immediate weight-bearing postoperatively |
|
| Partial-weight bearing | Active Comparator | Partial weight-bearing for the first 6 weeks postoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full weight-bearing | Procedure | Instruction for full and immediate weight-bearing postoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Return to work | Rate of return to work | 3 months |
| Physical component summary | Physical component summary of the SF-36 questionnaire | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Return to work | Rate of return to work | 6 months |
| Return to work | Rate of return to work | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total ground force during gait | Measurement of lower leg activity using pressure insoles | 3 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aleksi Reito, Assoc prof | Contact | +358444729631 | aleksi.reito@pshp.fi | |
| Satu Ylä-Mononen | Contact | satu.yla-mononen@pshp.fi |
| Name | Affiliation | Role |
|---|---|---|
| Aleksi Reito, Assoc prof | Tampere University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Finland Hospital Nova | Not yet recruiting | Jyväskylä | Central Finland | Finland |
IDP can be shared based on a reasonable request
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On a reasonable request along with a research plan.
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| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D000093002 | Partial Weight-Bearing |
| D005594 | Fracture Fixation, Intramedullary |
| ID | Term |
|---|---|
| D016474 | Weight-Bearing |
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
| D005593 | Fracture Fixation, Internal |
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Randomized controlled clinical trial
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| Partial weight-bearing | Procedure | Instruction for partial weight-bearing for 6 weeks postoperatively |
|
| Intramedullary nailing | Procedure | Intramedullary nailing of the fractured tibial shaft. |
|
| Physical component summary | Physical component summary of the SF-36 questionnaire | 6 months |
| Physical component summary | Physical component summary of the SF-36 questionnaire | 12 months |
| Total sick leave | Overall length of sick leave | 12 months |
| Lower extremity functional scale | Measurement of lower extremity function with a scale from 0 (worst) to 100 (best). | 3 months |
| Lower extremity functional scale | Measurement of lower extremity function with a scale from 0 (worst) to 100 (best). | 6 months |
| Lower extremity functional scale | Measurement of lower extremity function with a scale from 0 (worst) to 100 (best). | 12 months |
| Lower extremity functional scale | Measurement of lower extremity function with a scale from 0 (worst) to 100 (best). | 24 months |
| 36-Item Short Form Survey | 3 months |
| 36-Item Short Form Survey | 6 months |
| 36-Item Short Form Survey | 12 months |
| 36-Item Short Form Survey | 24 months |
| Tegner activity level scale | Method of grading work and sporting activities | 3 months |
| Tegner activity level scale | Method of grading work and sporting activities | 6 months |
| Tegner activity level scale | Method of grading work and sporting activities | 12 months |
| Tegner activity level scale | 24 months |
| University of California and Los Angeles activity level scale | Method of grading work and sporting activities | 3 months |
| University of California and Los Angeles activity level scale | Method of grading work and sporting activities | 6 months |
| University of California and Los Angeles activity level scale | Method of grading work and sporting activities | 12 months |
| University of California and Los Angeles activity level scale | Method of grading work and sporting activities | 24 months |
| Complications | Surgery related complications | 6 weeks |
| Complications | Surgery related complications | 3 months |
| Complications | Surgery related complications | 6 months |
| Complications | Surgery related complications | 12 months |
| Complications | Surgery related complications | 24 months |
| Tampere Univeristy Hospital | Recruiting | Tampere | Pirkanmaa | 33520 | Finland |
|
| Turku University Hospital | Not yet recruiting | Turku | Southwest Finland | Finland |
|
| D005592 |
| Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |