RecruitingNot ApplicableNCT04847115

Treatment of Fifth Metatarsal Zone 3 Fractures

Treatment of Fifth Metatarsal Zone 3 Fractures - A Prospective, Randomized, Controlled Trial


Sponsor

Ostfold Hospital Trust

Enrollment

100 participants

Start Date

Apr 10, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria1

  • Zone 3 fracture

Exclusion Criteria11

  • 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

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Interventions

PROCEDUREOperative

Intramedullary screw fixation

OTHERWalking 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.


Locations(3)

Østfold Hospital Trust

Grålum, Norway

Akershus University Hospital

Lørenskog, Norway

Oslo University Hospital

Oslo, Norway

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NCT04847115