Treatment of Fifth Metatarsal Zone 3 Fractures
Primary Purpose
Fractures, Stress, Metatarsal Fracture
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Operative
Walking boot orthosis
Sponsored by
About this trial
This is an interventional treatment trial for Fractures, Stress
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Operative
Non-operative
Arm 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.
The patients in this arm will have non-operative treatment with a walking boot orthosis for six weeks. They will weight bear as tolerated
Outcomes
Primary Outcome Measures
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".
Secondary Outcome Measures
Palpatory pain
Visual Analog Scale below 3
Radiological healing
Time to radiological callus formation
Work status
Time of sick leave
Refracture
Rate of refractures
Delayed union
Rate of delayed unions
Nonunions
Rate of nonunions
Level of activity
Time to normal activity level is resumed
Full Information
NCT ID
NCT04847115
First Posted
April 9, 2021
Last Updated
April 14, 2021
Sponsor
Ostfold Hospital Trust
Collaborators
Oslo University Hospital, University Hospital, Akershus
1. Study Identification
Unique Protocol Identification Number
NCT04847115
Brief Title
Treatment of Fifth Metatarsal Zone 3 Fractures
Official Title
Treatment of Fifth Metatarsal Zone 3 Fractures - A Prospective, Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 10, 2021 (Anticipated)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ostfold Hospital Trust
Collaborators
Oslo University Hospital, University Hospital, Akershus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Stress, Metatarsal Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospecitve, randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Operative
Arm Type
Active Comparator
Arm 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.
Arm Title
Non-operative
Arm Type
Active Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Operative
Other Intervention Name(s)
Osteosynthesis
Intervention Description
Intramedullary screw fixation
Intervention Type
Other
Intervention Name(s)
Walking boot orthosis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain free weight bearing
Description
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 Outcome Measure Information:
Title
Palpatory pain
Description
Visual Analog Scale below 3
Time Frame
2 years
Title
Radiological healing
Description
Time to radiological callus formation
Time Frame
2 years
Title
Work status
Description
Time of sick leave
Time Frame
2 years
Title
Refracture
Description
Rate of refractures
Time Frame
2 years
Title
Delayed union
Description
Rate of delayed unions
Time Frame
2 years
Title
Nonunions
Description
Rate of nonunions
Time Frame
2 years
Title
Level of activity
Description
Time to normal activity level is resumed
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marius Molund, PhD
Phone
0047 90093988
Email
marius.molund@so-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marius Molund, PhD
Organizational Affiliation
Ostfold HT
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Fifth Metatarsal Zone 3 Fractures
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