Fifth Metatarsal Orthopedic Outcome Trial

NCT05450107 | Unknown DMC

• 1 other identifier: 80748.075.22
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief Summary

Fractures of the shaft, distal to zone three, of the fifth metatarsal often occur after foot distortion. There is very little evidence available regarding the optimal treatment. Currently the most common treatment is prolonged cast immobilization. Operative treatment has been reported as an alternative and could promote early recovery. No comparative study has been published regarding optimal treatment

Conditions

Metatarsal Fracture

Outcome Measures

Primary Outcomes (1)

• Numerical rating scale-11 score for pain 3 months

  Numerical rating scale, score ranging from 0-10 where 10 is a worse outcome

  3 months after intervention

Secondary Outcomes (9)

• Numerical rating scale-11 score for pain through time

  0-12 months after intervention

• American Orthopedic Foot &Ankle Society Lesser Toe Scale

  3 months after intervention

• Foot and Ankle Ability Measure

  6 weeks, 3,6 and 12 months after intervention

• Patient Reported Outcome Measure Information System - Mobility

  6 weeks, 3,6 and 12 months after intervention

• Patient Reported Outcome Measure Information System - Pain Interference

  6 weeks, 3,6 and 12 months after intervention

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group is offered surgical treatment of the shaft fracture of the fifth metatarsal bone with ORIF. Depending on the type of shaft fracture this will be either lag screw fixation or plate fixation. After surgery a period of cast immobilisation with gradual increase of weight bearing will commence

Procedure: Open Reduction Internal Fixation

Control

ACTIVE COMPARATOR

The control group (conservative treatment), will receive a period of cast immobilisation, with a gradual increase in weight bearing by protocol.

Procedure: Cast immobilisation

Interventions

Open Reduction Internal Fixation PROCEDURE

Surgical intervention by lag screw or plate fixation

Intervention

Cast immobilisation PROCEDURE

Cast immobilsation for a total of 6 weeks with gradual increase in weight bearing after 2 weeks

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older at the time of study entry
• Informed consent
• Competent to participate in follow up and fill out questionnaires
• Dislocated (1mm or more on plain radiography) fracture of the shaft, distal from zone 3, of the fifth metatarsal according to the Orthopedic Trauma Association (OTA) classification 87.5.3 A-C

You may not qualify if:

• Open fracture
• Proximal fifth metatarsal fracture, Jones fracture
• Clinically significant or symptomatic vascular or neurologic pathology on the ipsilateral leg
• Former surgery or history of development disorder of the contralateral fifth metatarsal
• Multiple fractured metatarsals in the affected foot
• Medical history of Rheumatoid Arthritis
• Unable to undergo surgical procedure

Sponsors & Collaborators

• Isala: lead

Study Sites (3)

Rijnstate ziekenhuis

Arnhem, Gelderland, 6815AD, Netherlands

RECRUITING

IsalaK

Zwolle, Overijssel, 8025AB, Netherlands

RECRUITING

Martini ziekenhuis

Groningen, 9728NT, Netherlands

RECRUITING

Study Officials

• Rutger Zuurmond, MD, PhD

  Isala

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maarten Cornelissen, MD

CONTACT

0886248117; m.p.cornelissen@isala.nl

Roelina Munnik-Hagewoud, PhD

CONTACT

0886245375; r.munnik@isala.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Model Details: Randomized controlled clinical intervention trial

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 8, 2022
• Study Start: September 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)