Treatment of Fifth Metatarsal Zone 3 Fractures

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

Study Overview

• Status: Recruiting
• Conditions: Fractures, Stress; Metatarsal Fracture
• Intervention / Treatment: Procedure: Operative; Other: Walking boot orthosis

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marius Molund, PhD; Phone Number: 0047 90093988; Email: marius.molund@so-hf.no

Study Locations

• Norway
  • Grålum, Norway
    • Recruiting
    • Østfold Hospital Trust
    • Contact: Petter Morten Pettersen, MD
  • Lørenskog, Norway
    • Recruiting
    • Akershus University Hospital
    • Contact: Tor Kristian Andresen, MD
  • Oslo, Norway
    • Recruiting
    • Oslo University Hospital
    • Contact: Are Haukåen Stødle, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Operative; Intramedullary screw fixation; Other Names: Osteosynthesis; Other: 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.
Active Comparator: 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	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Palpatory pain	Visual Analog Scale below 3	2 years
Radiological healing	Time to radiological callus formation	2 years
Work status	Time of sick leave	2 years
Refracture	Rate of refractures	2 years
Delayed union	Rate of delayed unions	2 years
Nonunions	Rate of nonunions	2 years
Level of activity	Time to normal activity level is resumed	2 years

Collaborators and Investigators

• Sponsor: Ostfold Hospital Trust
• Collaborators: Oslo University Hospital; University Hospital, Akershus
• Investigators: Principal Investigator: Marius Molund, PhD, Ostfold HT

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2021
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2030

Study Registration Dates

• First Submitted: April 9, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Stress
• Other Study ID Numbers: 201144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No