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| Name | Class |
|---|---|
| Tampere University Hospital | OTHER |
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PRCT multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.
Prospective randomized controlled multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Splint 3 weeks | Active Comparator | Removable ankle brace/splint |
|
| Cast 3 weeks | Active Comparator | Below-the-knee cast (glass fiber) |
|
| Cast 6 weeks | Active Comparator | Below-the-knee cast (glass fiber) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Splint 3 weeks | Other | A removable orthosis/splint. Dynacast/Ortho-Glass AS (BSN Medical). Splint is used for 3 weeks and no additional support is used after splint removal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Olerud-Molander score | Ankle functional outcome measure | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| FAOS | Foot and Ankle Outcome Score | 1 year |
| VAS | Visual Analogue Scale pain and function | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harri J Pakarinen, MD, PhD | Oulu University Hospital | Study Director |
| Tero HJ Kortekangas, MD | Oulu University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OYS, kirurgian klinkka, Oulu | Oulu | 90100 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30674451 | Derived | Kortekangas T, Haapasalo H, Flinkkila T, Ohtonen P, Nortunen S, Laine HJ, Jarvinen TL, Pakarinen H. Three week versus six week immobilisation for stable Weber B type ankle fractures: randomised, multicentre, non-inferiority clinical trial. BMJ. 2019 Jan 23;364:k5432. doi: 10.1136/bmj.k5432. |
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| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D013165 | Splints |
| C119975 | POLR1G protein, human |
| ID | Term |
|---|---|
| D016267 | External Fixators |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
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| Cast 3 weeks | Other | A standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is removed after 3 weeks and no additional support is used after cast removal. |
|
| Cast 6 weeks | Other | standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is changed after 3 weeks and removed after 6 weeks. No additional support is used after cast removal. |
|
| RAND 36 Health item survey | Quality of life measurement | 1 year |
| Fracture healing | 1 year |
| D004864 |
| Equipment and Supplies |
| D053831 | Surgical Fixation Devices |