Trials / Recruiting
RecruitingNCT04847115
Treatment of Fifth Metatarsal Zone 3 Fractures
Treatment of Fifth Metatarsal Zone 3 Fractures - A Prospective, Randomized, Controlled Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Ostfold Hospital Trust · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Operative | Intramedullary screw fixation |
| OTHER | Walking boot orthosis | 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. |
Timeline
- Start date
- 2021-04-10
- Primary completion
- 2026-03-31
- Completion
- 2030-03-31
- First posted
- 2021-04-19
- Last updated
- 2024-04-29
Locations
3 sites across 1 country: Norway
Source: ClinicalTrials.gov record NCT04847115. Inclusion in this directory is not an endorsement.