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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
| University Hospital, Akershus | OTHER |
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The fifth metatarsal is one of the bones where stress fractures can occur. Current literature provides support for both operative and non-operative treatment, but is mostly based on retrospective studies. One small randomized controlled trial reported faster recovery in the surgery group, but this study is probably subject to selection bias as well as underpowered design. There is a need to strengthen the knowledge base regarding treatment of stress fractures in the fifth metatarsal. This study seeks to answer whether osteosynthesis with an intramedullar screw fixation gives faster painfree weight bearing compared to non-operative treatment with a walking boot.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operative | Active Comparator | The patients in this arm will be treated operatively with intramedullar screw osteosynthesis. In addition to this, they will weight bear as tolareted in a walking boot orthosis for six weeks. |
|
| Non-operative | Active Comparator | The patients in this arm will have non-operative treatment with a walking boot orthosis for six weeks. They will weight bear as tolerated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Operative | Procedure | Intramedullary screw fixation |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Pain free weight bearing | Defined as Visual Analoge Scale below 3. The scale range is 0 to 10, where 0 means "no pain" and 10 means "worst pain". | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Palpatory pain | Visual Analog Scale below 3 | 2 years |
| Radiological healing | Time to radiological callus formation | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marius Molund, PhD | Contact | 0047 90093988 | marius.molund@so-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| Marius Molund, PhD | Ostfold HT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Østfold Hospital Trust | Recruiting | Grålum | Norway |
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| ID | Term |
|---|---|
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Prospecitve, randomized trial
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| Walking boot orthosis | Other | Non-operative treatment with walking boot orthosis for six weeks. The non-operative study arm will use walking boot orthosis only. The operative study arm will use walking boot orthosis as adjuvant treatment. |
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| Work status | Time of sick leave | 2 years |
| Refracture | Rate of refractures | 2 years |
| Delayed union | Rate of delayed unions | 2 years |
| Nonunions | Rate of nonunions | 2 years |
| Level of activity | Time to normal activity level is resumed | 2 years |
| Akershus University Hospital | Recruiting | Lørenskog | Norway |
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| Oslo University Hospital | Recruiting | Oslo | Norway |
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