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

Muscle Weakness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04168411
• Other study ID #: 2018/536
• Status: Completed
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: September 9, 2019

Study information

• Verified date: November 2019
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 9, 2019
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Healing Fracture of Bone
• Metatarsal Fracture
• Muscle Weakness
• Paresis

Intervention

Procedure:
• Symptomatic Treatment
Conservative treatment methods of tuberosity fractures of the proximal fifth metatarsal

Locations

Country	Name	City	State
Turkey	Istanbul University, Istanbul Faculty of Medicine	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Days with using an assistive device	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.	through study completion, an average of 6 months
Other	Number of Days with a take of analgesia	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.	through study completion, an average of 6 months
Other	Number of Days with unable to work	The time taken of unable to work was investigated and compared between both groups.	through study completion, an average of 6 months
Other	Rates of Complications	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.	through study completion, an average of 6 months
Primary	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	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.	baseline, 2, 4, 8,12 and 24 weeks follow-up visit
Secondary	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.	baseline, 2nd, 4th, 8th,12th and 24th week follow-up visit