Treatment of Fifth Metatarsal Zone 3 Fractures

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorOstfold Hospital Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Zone 3 fracture

Disqualifiers

Neuropathy

Open fractures

High energy injuries

Associated injury in the same or opposite extremity that may affect treatment or rehabilitation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Operative

    Procedure/Surgery

    Intramedullary screw fixation

  • Walking boot orthosis

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: OperativeActive comparator 2 interventions
Group B: Non-operativeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Palpatory pain

Visual Analog Scale below 3

Time frame
2 years
2

Radiological healing

Time to radiological callus formation

Time frame
2 years
3

Work status

Time of sick leave

Time frame
2 years
4

Refracture

Rate of refractures

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ostfold Hospital Trust

Lead sponsor

Oslo University Hospital

Collaborator

University Hospital, Akershus

Collaborator