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

Primary Purpose

Muscle Weakness, Metatarsal Fracture, Healing Fracture of Bone

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Symptomatic Treatment
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Weakness focused on measuring metatarsal, fracture, muscle weakness, isokinetic test,

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Istanbul University, Istanbul Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Symptomatic treatment group

Cast group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changed of Baseline VAS-FA Scores at 6 months
The investigators was measured clinical outcomes, using the validated "Visual Analogue Scale Foot and Ankle (VAS-FA) Score". VAS-FA score is numbered from 0 to 100. 100 is the best health and 0 is the worst health.
Changed of Baseline EuroQol-5D VAS Scores at 6 months
The investigators was measured clinical outcomes using The EuroQol-5D visual analogue scale (EQ-5D VAS). (EQ-5D VAS is numbered from 0 to 100. 100 is the best health and 0 is the worst health.

Full Information

First Posted
November 13, 2019
Last Updated
November 17, 2019
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04168411
Brief Title
Comparison Different Method Treatment in Tuberosity Fractures of the Proximal Fifth Metatarsal
Official Title
A Prospective Comparison of Clinical, Functional, and Isokinetic Outcomes Between Short Leg Cast Immobilization and Symptomatic Treatment in Tuberosity Fractures of the Proximal Fifth Metatarsal
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
September 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

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
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.
Detailed Description
We prospectively treated 73 patients with 5th metatarsal base fractures (Zone 1) who came to the emergency department. Patients were allocated to a treatment group using an electronic random number generator. The generation of an even number randomized the participant to a below-knee cast, and an odd number to a double-layered elasticated bandage. In all, patients were allocated to wear a double layered elasticated bandage (group 1) applied by S.B and patients were given a below-knee cast (group 2) applied by D.K. Duration of both treatments were for four weeks and the cast removed in that time in our clinic. This reference form of treatment was the same as in previous reports. The non-injured extremity was measured with isokinetic test at initial injury time for evaluation of side effect of immobilization after treatment. At that time, patients were asked for height, weight and pain scores. Body muscle index was calculated for all patients. Tobacco using was also asked.To measure clinical outcomes, using the validated Visual Analogue Scale Foot and Ankle (VAS-FA) score [7] and The EuroQol-5D visual analogue scale (EQ-5D VAS) score were used [8]. The VAS-FA score ranges from 0 to 100 points: higher scores indicate a better functional outcome. EQ-5D VAS score was used as a secondary outcome measure: this ranges from 0 to 100. Baseline functional scores were collected at the time of consult in the clinic. Both ankle plantar-dorsiflexors and inversion-eversion'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 (T.Ş) 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 non-injured extremity. The non-injured extremity was measured at initial injury time for evaluation of side effect of both treatment methods. The tests were started with non-injured sides of the patients and measurements at low angular velocity. The dynamometer was calibrated at the beginning of each testing session. Subjects were tested in prone position and stabilized in the exercise chair as per the manufacturer's recommendation. The anatomical axis of the ankle was aligned with the axis of the dynamometer while the foot was secured to the foot plate with velcros. Proximal stabilization was achieved with the straps at the thigh and calf. In the test, dorsiflexion-plantarflexion and inversion-eversion peak torque force (strength) measurements were performed in 3 trials and 3 tests repetitions at 30 degrees/sec angular speed for both side of the patient. All of the patients were given follow-up appointments at 2, 4, 8, 12 and 24 week interval at our clinic. Radiographs were similarly scheduled for 4, 8, and 12 week intervals to assess bony healing. However, functional outcomes and isokinetic test was applied also at 24 week control. At second visit, isokinetic test was not applied. These studies were started on fixed ground and then continued on moving boards. Standard rehabilitation program was given for all patients each group included joint mobilizations, passive stretching, electrotherapy-ice compression for pain relieving and ankle proprioceptive exercises, as considered necessary by same author (T.Ş).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness, Metatarsal Fracture, Healing Fracture of Bone
Keywords
metatarsal, fracture, muscle weakness, isokinetic test,

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Symptomatic treatment group
Arm Type
Experimental
Arm Description
The patients were allocated to wear a double layered elasticated bandage for treatment 5th metatarsal base fractures (Zone 1).
Arm Title
Cast group
Arm Type
Active Comparator
Arm Description
The patients were given a below-knee cast for treatment 5th metatarsal base fractures (Zone 1).
Intervention Type
Procedure
Intervention Name(s)
Symptomatic Treatment
Intervention Description
Conservative treatment methods of tuberosity fractures of the proximal fifth metatarsal
Primary Outcome Measure Information:
Title
Changed of Baseline Isokinetic Muscle Strength at 6 months
Description
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.
Time Frame
Isokinetic Muscle Strength test was scheduled for baseline, 4, 8,12 and 24 week intervals to assess ankle muscle strength
Secondary Outcome Measure Information:
Title
Changed of Baseline VAS-FA Scores at 6 months
Description
The investigators was measured clinical outcomes, using the validated "Visual Analogue Scale Foot and Ankle (VAS-FA) Score". VAS-FA score is numbered from 0 to 100. 100 is the best health and 0 is the worst health.
Time Frame
baseline, 2, 4, 8,12 and 24 weeks follow-up visit
Title
Changed of Baseline EuroQol-5D VAS Scores at 6 months
Description
The investigators was measured clinical outcomes using The EuroQol-5D visual analogue scale (EQ-5D VAS). (EQ-5D VAS is numbered from 0 to 100. 100 is the best health and 0 is the worst health.
Time Frame
baseline, 2nd, 4th, 8th,12th and 24th week follow-up visit
Other Pre-specified Outcome Measures:
Title
Number of Days with using an assistive device
Description
Patients use the Canadian sticks while walking for decrease their pain level. The time of the using assistive device was investigated and compared between both groups.
Time Frame
through study completion, an average of 6 months
Title
Number of Days with a take of analgesia
Description
Patients take the pills for their pain. Our drug choose is paracetamol for patients. The time of take of drug was investigated and compared between both groups.
Time Frame
through study completion, an average of 6 months
Title
Number of Days with unable to work
Description
The time taken of unable to work was investigated and compared between both groups.
Time Frame
through study completion, an average of 6 months
Title
Rates of Complications
Description
Every treatment method has got a lot of complications. The complications of both treatment methods were investigated and noted. The complication rates of the treatment methods were compared between the two groups.
Time Frame
through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged over 18 years Acute (presented within one week of injury) Zone 1 fractures of fifth metatarsi Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Turgut Akgul, MD
Organizational Affiliation
Istanbul University
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University, Istanbul Faculty of Medicine
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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