Clinical Trials Directory

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

TypeNameDescription
PROCEDUREOperativeIntramedullary screw fixation
OTHERWalking boot orthosisNon-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.