Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201909505821864 Date of Approval: 19/09/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of low-intensity pulsed ultrasound in healing of lower limb fractures
Official scientific title Efficacy of low-intensity pulsed ultrasound in healing of lower limb fractures
Brief summary describing the background and objectives of the trial Fracture healing represents a global challenge for patients and healthcare practitioners. The challenge is the normal healing process of 6-8 weeks which gets more extreme when the healing is delayed/non-union. The health care practitioners got to discover an approach to investigate the causes of delayed/ non-union with the goal to have the capacity to achieve better medical alternatives to accelerate better treatment options to speed up the fracture healing. This increases costs to the department of health. This now acquires added challenges to the patient, possible increased disability chances due to lengthy fracture healing, losing their jobs because of long sick time taken off work, which may prompt to loss of income, family burden because they need to be partly dependent and psychosocial problems due to the circumstances the patient find self in. Recent studies have shown that the effect of ultrasound on fracture healing depends on the intensity used. Low-intensity ultrasound has been used to accelerate fracture healing. Low doses of ultrasound did not have an adverse effect on bone growth in the short-term follow-up. Low-intensity ultrasound has been used to accelerate fracture healing) and has been proven to be effective (Gan et al, 2014; Liul et al, 2014; Morshed, 2014). The aim of the study is to determine the effect of non-invasive low-intensity US on the healing of lower limb fractures. The objective of the study was to establish the lower limb fracture outcome (callus formation) in lower limb fractures patients managed with LIPUS compared to the patients only managed surgically and to establish the influence of demographic, and health status variables and smoking in patients managed with LIPUS on fracture healing.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/01/2017
Actual trial start date 01/02/2017
Anticipated date of last follow up 30/09/2017
Actual Last follow-up date 12/12/2017
Anticipated target sample size (number of participants) 115
Actual target sample size (number of participants) 115
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Low intensity pulsed ultrasound The preset intensity of 0.03 W/cm2, Frequency of 1.5MHz, Pulse width of 200 µs 20 minutes every alternate days The patients were treated with ultrasound for 20 min The area to be treated was cleaned with clean water and the ultrasound head was placed on the affected area, then the machine was started as the machine was preset as above. 47
Control Group Sham ultrasound machine Similar settings like the intervention group were set, though it was sham machine. The preset intensity of 0.03 W/cm2, Frequency of 1.5MHz, Pulse width of 200 µs was set. 20 minutes every alternate days for 20 days The area to be treated was washed and cleaned with clean water. The head of ultrasound was placed on the affected area, the machine was swiched on and kept running for 20 minutes. 48 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients admitted with lower limb fractures of the lower limbs Patients with multiple fractures were excluded The patients who do not reside in the Gauteng region were excluded for follow up purposes 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/12/2016 University of the Witwatersrand Human resource ethics committee medical
Ethics Committee Address
Street address City Postal code Country
Faculty of Health Sciences, Phillip Tobias Building, 3rd Floor, Office 301, 29 Princess of Wales Terrace, Parktown, 2193 Parktown 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Radiographic methods were used to assess fracture healing. Measuring of callus formation was used. 6 weeks, 12 weeks and 18 weeks
Secondary Outcome Measuring of cortical bridging using X-rays 6 weeks, 12 weeks and 18 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Steve Biko Academic Hospital 349 Steve Biko Road Pretoria 0002 South Africa
Kalafong Academic Hospital Klipspringer St, Atteridgeville Pretoria 0008 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Enraf Mediotronics 545 Nupen Cres, Halfway House Midrand 1685 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Mediotronics 545 Nupen Cres Midrand 1685 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nontembiso Magida nontembiso.magida@up.ac.za +27829638547 91 Bayley Street
City Postal code Country Position/Affiliation
Farrarmere 1501 South Africa Principal researcher
Role Name Email Phone Street address
Public Enquiries Nontembiso Magida nontembiso.magida@up.ac.za +27829638547 91 Bayley Street
City Postal code Country Position/Affiliation
Farrarmere 1501 South Africa Lecturer
Role Name Email Phone Street address
Scientific Enquiries Hellen Myezwa hellen.myezwa@wits.ac.za +27834696249 7 York Road
City Postal code Country Position/Affiliation
Parktown 2193 South Africa Head of School
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data collected from the each patient will be shared if needed Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available from 2019 to 2020 Controlled: Only medical related people in orthopaedics and physiotherapy that may have access to the data if needed
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information