Treatment of Fifth Metatarsal Zone 3 Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-10

Study Completion Date

2030-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Fractures, Stress Metatarsal Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospecitve, randomized trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Operative

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.

Group Type ACTIVE_COMPARATOR

Operative

Intervention Type PROCEDURE

Intramedullary screw fixation

Walking boot orthosis

Intervention Type OTHER

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.

Non-operative

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

Group Type ACTIVE_COMPARATOR

Walking boot orthosis

Intervention Type OTHER

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.

Interventions

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Operative

Intramedullary screw fixation

Intervention Type PROCEDURE

Walking 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.

Intervention Type OTHER

Other Intervention Names

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Osteosynthesis

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No