Comparison Different Method Treatment in Tuberosity Fractures of the Proximal Fifth Metatarsal

NCT04168411 | Completed

• 1 other identifier: 2018/536
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Fracture of the base of the fifth metatarsal is one of the most common injuries in ankle trauma. There are many conservative treatment protocols for fifth metatarsal base fractures which have up to 99% success. Short leg cast and walking boot are conservative treatment methods that aim to prevent weight-bearing. There are many different conservative treatment methods that allow weight-bearing such as an elastic bandage. There was no significant difference between cast and symptomatic treatment in the previous studies. Muscle atrophy developing after immobilization with cast may adversely affect the daily activities of the patient in the first few months. However, there was no study comparing the effect of these two treatment methods on ankle muscle strength. In this study, the investigators compared the strength of the ınjured and healthy ankle muscle when symptomatic and cast treatment methods are applied to patients with tuberosity fractures of proximal fifty metatars. In addition, patients' functional, clinic and radiological outcomes were also compared.

Conditions

Muscle Weakness; Metatarsal Fracture; Healing Fracture of Bone

Keywords

metatarsal, fracture, muscle weakness, isokinetic test,

Outcome Measures

Primary Outcomes (1)

• Changed of Baseline Isokinetic Muscle Strength at 6 months

  Both ankle plantar-dorsiflexion muscle strength and inversion-eversion muscle strength (peak torque %BW (Body Weight)) were measured with an isokinetic dynamometer (Cybex Humac Norm, CA, USA) at Isokinetic Test Laboratory of Sports Medicine in the Istanbul Medical Faculty. Test procedure was performed by the same investigator in all cases for ensuring standardization. The muscle strength can be defined as the capacity of a muscle to withstand great force. Injured extremity values were compared with healthy extremity. he healthy extremity was measured at initial injury time for evaluation of side effect of both treatment methods.

  Isokinetic Muscle Strength test was scheduled for baseline, 4, 8,12 and 24 week intervals to assess ankle muscle strength

Secondary Outcomes (2)

• Changed of Baseline VAS-FA Scores at 6 months

  baseline, 2, 4, 8,12 and 24 weeks follow-up visit

• Changed of Baseline EuroQol-5D VAS Scores at 6 months

  baseline, 2nd, 4th, 8th,12th and 24th week follow-up visit

Other Outcomes (4)

• Number of Days with using an assistive device

  through study completion, an average of 6 months

• Number of Days with a take of analgesia

  through study completion, an average of 6 months

• Number of Days with unable to work

  through study completion, an average of 6 months

Study Arms (2)

Symptomatic treatment group

EXPERIMENTAL

The patients were allocated to wear a double layered elasticated bandage for treatment 5th metatarsal base fractures (Zone 1).

Procedure: Symptomatic Treatment

Cast group

ACTIVE COMPARATOR

The patients were given a below-knee cast for treatment 5th metatarsal base fractures (Zone 1).

Procedure: Symptomatic Treatment

Interventions

Symptomatic Treatment PROCEDURE

Conservative treatment methods of tuberosity fractures of the proximal fifth metatarsal

Cast group; Symptomatic treatment group

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged over 18 years
• Acute (presented within one week of injury) Zone 1 fractures of fifth metatarsi

You may not qualify if:

• Zone 2-3 fractures
• Diabetes mellitus
• Osteoporotic bone (T score\<-2.5),
• History of osteoporotic drug therapy,
• Other lower extremity any fracture,
• Previous foot surgery or fracture in both lower extremity,
• Chronic fracture, pathological fracture,
• Aged over 65 years (congruity of muscle strength test)
• Open fracture

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscle Weakness; Fractures, Bone

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Wounds and Injuries

Study Officials

• Turgut Akgul, MD

  Istanbul University

  STUDY DIRECTOR

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: Medical Doctor

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 19, 2019
• Study Start: April 15, 2018
• Primary Completion: June 20, 2019
• Study Completion: September 9, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-11

Locations

TU (1)