Treatment of Fifth Metatarsal Zone 3 Fractures

Ostfold Hospital Trust

Status: Enrolling

Conditions: Fractures, Stress; Metatarsal Fracture

Treatments: Procedure: Operative; Other: Walking boot orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT04847115

201144

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Operative

Active Comparator group

Description:

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.

Treatment:

Procedure: Operative

Other: Walking boot orthosis

Non-operative

Active Comparator group

Description:

The patients in this arm will have non-operative treatment with a walking boot orthosis for six weeks. They will weight bear as tolerated

Treatment:

Other: Walking boot orthosis