An interventional study of Operative and Walking boot orthosis in Fractures, Stress and Metatarsal Fracture, sponsored by Ostfold Hospital Trust. Recruiting at 3 sites in Norway. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-29.
Sponsored by Ostfold Hospital Trust · Not applicable, Interventional, and Treatment
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.
23 studies on the registry are indexed under Fractures, Stress; 4 are open to participants now.
This study's planned enrollment of 100 is close to the median of 110 across 17 interventional studies indexed under Fractures, Stress.
Browse Fractures, Stress studies →Ostfold Hospital Trust is the lead sponsor of 50 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
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.
Procedure: Operative · Other: Walking boot orthosis
The patients in this arm will have non-operative treatment with a walking boot orthosis for six weeks. They will weight bear as tolerated
Other: Walking boot orthosis
Intramedullary screw fixation
Also known as: Osteosynthesis
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.
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".
Time frame: 2 years
Palpatory pain
Visual Analog Scale below 3
Time frame: 2 years
Radiological healing
Time to radiological callus formation
Time frame: 2 years
Work status
Time of sick leave
Time frame: 2 years
Refracture
Rate of refractures
Time frame: 2 years
Delayed union
Rate of delayed unions
Time frame: 2 years
Nonunions
Rate of nonunions
Time frame: 2 years
Level of activity
Time to normal activity level is resumed
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2021 (actual). Primary completion is estimated for Mar 2026, 59 months after the start.
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Ostfold Hospital Trust