NCT04847115

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
47mo left

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Apr 2021Mar 2030

First Submitted

Initial submission to the registry

April 9, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

April 10, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2030

Expected
Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

5 years

First QC Date

April 9, 2021

Last Update Submit

April 26, 2024

Conditions

Fractures, StressMetatarsal Fracture

Outcome Measures

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".

    2 years

Secondary Outcomes (7)

  • Palpatory pain

    2 years

  • Radiological healing

    2 years

  • Work status

    2 years

  • Refracture

    2 years

  • Delayed union

    2 years

  • +2 more secondary outcomes

Study Arms (2)

Operative

ACTIVE COMPARATOR

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.

Procedure: OperativeOther: Walking boot orthosis

Non-operative

ACTIVE COMPARATOR

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

Other: Walking boot orthosis

Interventions

OperativePROCEDURE

Intramedullary screw fixation

Also known as: Osteosynthesis
Operative
Walking boot orthosisOTHER

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-operativeOperative

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Zone 3 fracture

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Østfold Hospital Trust

Grålum, Norway

RECRUITING

Akershus University Hospital

Lørenskog, Norway

RECRUITING

Oslo University Hospital

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Fractures, Stress

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Marius Molund, PhD

    Ostfold HT

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marius Molund, PhD

CONTACT

0047 90093988marius.molund@so-hf.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospecitve, randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2021

First Posted

April 19, 2021

Study Start

April 10, 2021

Primary Completion

March 31, 2026

Study Completion (Estimated)

March 31, 2030

Last Updated

April 29, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

NO(3)