Metatarsal Fracture Clinical Trial
Official title:
Treatment of Fifth Metatarsal Zone 3 Fractures - A Prospective, Randomized, Controlled Trial
NCT number | NCT04847115 |
Other study ID # | 201144 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 10, 2021 |
Est. completion date | March 31, 2030 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | March 31, 2030 |
Est. primary completion date | March 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Zone 3 fracture Exclusion Criteria: - Neuropathy - Open fractures - High energy injuries - Associated injury in the same or opposite extremity that may affect treatment or rehabilitation - Pressure ulcer(s) - Lack of consent competence - Fracture radiologically confirmed more than six months ago - No possibility of follow-up at one of the study centers - Established pseudarthrosis - Medical condition that contraindicates surgery - Non-compliance |
Country | Name | City | State |
---|---|---|---|
Norway | Østfold Hospital Trust | Grålum | |
Norway | Akershus University Hospital | Lørenskog | |
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Ostfold Hospital Trust | Oslo University Hospital, University Hospital, Akershus |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Palpatory pain | Visual Analog Scale below 3 | 2 years | |
Secondary | Radiological healing | Time to radiological callus formation | 2 years | |
Secondary | Work status | Time of sick leave | 2 years | |
Secondary | Refracture | Rate of refractures | 2 years | |
Secondary | Delayed union | Rate of delayed unions | 2 years | |
Secondary | Nonunions | Rate of nonunions | 2 years | |
Secondary | Level of activity | Time to normal activity level is resumed | 2 years |
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