Effects of low-intensity pulsed ultrasound on tibial transport
| ISRCTN | ISRCTN13948004 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13948004 |
| Sponsor | Vall d'Hebron Institut de Recerca |
| Funder | Investigator initiated and funded |
- Submission date
- 08/07/2026
- Registration date
- 23/09/2026
- Last edited
- 23/09/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Some patients lose part of the tibia after a severe injury or bone infection. One way to rebuild the missing bone is called bone transport. In this treatment, a circular metal frame is attached to the leg and slowly moves a piece of bone across the gap. New bone forms behind it. This method can rebuild large bone defects, but patients often need to wear the frame for many months.
Low-intensity pulsed ultrasound, also called LIPUS, is a treatment that sends gentle ultrasound waves through the skin to the bone. It is painless and does not involve surgery. LIPUS has been used to help bone healing in other situations, but it is not clear whether it helps patients who are having tibial bone transport.
The aim of this study was to find out whether adding LIPUS treatment could reduce the time patients needed to wear the circular frame. The study also looked at bone healing on X-rays, patient satisfaction, leg function, treatment adherence, and safety.
Who can participate?
Adults aged 18 years or older could take part if they had a missing section of tibia caused by injury or infection and were being treated with tibial bone transport using a circular external frame.
What does the study involve?
This study took place in two hospitals in Spain. After the first stages of surgical treatment and bone transport had been completed, patients were randomly placed into one of two groups.
Patients in the LIPUS group used the EXOGEN® ultrasound device at home for 20 minutes every day. The device was placed on the skin over the area where new bone was forming. Treatment continued until the circular frame was removed. The device automatically recorded how many sessions were completed.
Patients in the control group received the same standard surgical treatment and follow-up but did not receive LIPUS.
The main measurement was the amount of time patients wore the circular frame, adjusted for the size of the bone defect. The study also assessed X-rays, treatment adherence, side effects or device problems, satisfaction, leg function, recurrence of infection, and amputation during follow-up.
What are the possible benefits and risks of participating?
Patients who received LIPUS may have benefited if the treatment helped the new bone mature faster, although this could not be guaranteed. The study may also help improve treatment for future patients with similar complex bone problems.
LIPUS is a non-surgical treatment and was used according to the device instructions. Possible disadvantages included the need to use the device every day, mild local discomfort or skin irritation where the device was applied, or technical problems with the device. All patients continued to receive standard surgical care and follow-up for their condition.
Where is the study run from?
Hospital Universitari Vall d’Hebron, Barcelona, and Hospital Clínico Universitario Virgen de la Arrixaca, Murcia (Spain)
When is the study starting and how long is it expected to run for?
October 2021 to January 2026
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Kushal Mukesh Lakhani Mahtani, kushallakhani@hotmail.com
Contact information
Scientific, Public
Ctra. Gral. del Rosario, 145
Santa Cruz de Tenerife
38010
Spain
 ORCID ID |
0000-0001-8801-2839 |
|---|---|
| Phone | +34 (0)922602000 |
| 1622253@uab.cat |
Principal investigator
Pg. de la Vall d'Hebron, 119, Horta-Guinardó
Barcelona
08035
Spain
| ORCID ID |
0000-0003-4128-3142 |
|---|---|
| Phone | +34 (0)934893000 |
| pablo.corona@uab.cat |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | A multicentre, open-label, parallel-group randomised controlled trial comparing low-intensity pulsed ultrasound versus standard care for reducing the external fixation index in adults undergoing tibial bone transport for post-traumatic or septic segmental tibial defects |
| Study acronym | ELIT |
| Study objectives | To compare the external fixation index (EFI) between patients undergoing tibial bone transport treated with adjunctive LIPUS technology and a control group and to evaluate final radiological regenerate quality, safety and adherence to LIPUS treatment, and patient satisfaction and functional outcomes between groups. |
| Ethics approval(s) |
1. Approved 08/10/2021, Research Ethics Committee for Medicines and Research Projects Committee of the Vall d’Hebron University Hospital (Pg. de la Vall d'Hebron, 119, Horta-Guinardó, Barcelona, 08035, Spain; +34 (0)934893000; ceic@vhir.org), ref: PR(ATR)335/2021 2. Approved 08/09/2021, Research Ethics Committee for Medicines (CEIm) Virgen de la Arrixaca Hospital (Ctra. Madrid-Cartagena, Murcia, 30120, Spain; +34 (0)968369500; ceim.arrixaca.sms@carm.es), ref: 2021-10-14-HCUVA |
| Health condition(s) or problem(s) studied | Post-traumatic or septic segmental tibial defects treated with bifocal bone transport using circular external fixation |
| Intervention | Randomisation was performed centrally using REDCap. Participants were allocated in a 1:1 ratio to the LIPUS group or the control group using a computer-generated randomisation sequence with permuted blocks, stratified by participating centre. Allocation was disclosed after completion of the initial reconstructive phases and once the patient was eligible for randomisation. The study was open-label and no sham/placebo device was used. Patients allocated to the LIPUS group received treatment with the EXOGEN® Ultrasound Bone Healing System. Therapy was initiated after randomization and after specific patient instruction on the use of the device. Thus, LIPUS intervention was focused on the bone regenerate maturation phase once the initial reconstructive phases of surgical treatment had been completed. Treatment consisted of a daily 20-minute application, performed at home, with the transducer placed on the skin over the bone regenerate and using coupling gel to facilitate transmission of the ultrasound signal. LIPUS therapy was continued until definitive removal of the circular external fixator. Actual treatment exposure was quantified using the internal log of the EXOGEN® device, which automatically records completed sessions. Treatment adherence was expressed as the percentage of completed sessions relative to the total number of prescribed sessions during the treatment period. Adequate adherence was defined as completion of at least 95% of the prescribed sessions. Participants in the control group received the same standard surgical and follow-up protocol for tibial bone transport using circular external fixation, but without adjunctive LIPUS treatment. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | EXOGEN® Ultrasound Bone Healing System |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/01/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 22 |
| Total final enrolment | 26 |
| Key inclusion criteria | 1. Age: 18 years old and older 2. Affected bone segment: tibia 3. Aetiology of the segmental bone defect: post-traumatic or infectious septic nonunion 4. Selected treatment: bone transport using circular external fixation according to the treatment protocol of the Osteoarticular Septic Surgery Unit (UCSO) at Vall d’Hebron University Hospital (HUVH) 5. Type of bone transport: bifocal, with a single osteotomy 6. Patients who freely and without coercion agree to participate in this clinical trial, and who have sufficient autonomy and capacity to read and understand the patient information sheet and sign the informed consent form for participation |
| Key exclusion criteria | 1. Paediatric patients 2. Bone defects of oncological aetiology 3. Bone transport procedures performed using monolateral external fixation 4. Trifocal bone transport procedures, involving double osteotomy 5. Relative contraindications and warnings for use of the EXOGEN® Ultrasound Bone Healing System |
| Date of first enrolment | 21/10/2021 |
| Date of final enrolment | 12/02/2024 |
Locations
Countries of recruitment
- Spain
Study participating centres
Barcelona
08035
Spain
Murcia
30120
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | Individual participant data will not be made publicly available because of the small sample size, the rarity and complexity of the condition, and the potential risk of participant re-identification. Anonymised aggregate data will be reported in the doctoral thesis and any resulting publications. Reasonable requests for additional anonymised data may be considered by the study investigators, subject to sponsor approval and applicable ethics and data protection requirements. |
Editorial Notes
09/07/2026: Study's existence confirmed by the Research Ethics Committee for Medicines and Research Projects Committee of the Vall d’Hebron University Hospital.
