Comparison of the results of two treatment systems in ankle injuries
| ISRCTN | ISRCTN71276902 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71276902 |
| Secondary identifying numbers | Código HULP 5242 |
- Submission date
- 22/10/2021
- Registration date
- 01/11/2021
- Last edited
- 01/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Syndesmotic injuries are injuries to the ligaments that connect the bones of the lower leg to the ankle joint. The current gold standard treatment for these is screw fixation where the bones are screwed together. However, this leads to problems due to the limited movement of the joint. Newer such devices as flexible TighRope Knotless have been developed which allow healing to take place without the use of screws.
The aim of this study is compare screw fixation with flexible fixation.
Who can participate?
Patients with a syndesmosis injury combined with an ankle fracture identified by clinical examination and X-ray
What does the study involve?
Participants will be randomly allocated to receive either dynamic (TighRope Knotless) or static fixation (Screw). Follow up is at 3, 6 and 12 months following surgery.
What are the possible benefits and risks of participating?
TighRope Knotless does not require a knot reducing wound complications related to the suture knot reported in previous studies performed with classic TighRope. This reduces risks related to a second surgery such as loss of reduction or infection.
Where is the study run from?
University Hospital Infanta Sofía, Madrid (Spain)
When is the study starting and how long is it expected to run for?
March 2019 to November 2023
Who is funding the study?
Foundation of Spanish Trauma and Orthopedic Surgery Society (SECOT).
Who is the main contact?
Patricia Morales Muñoz, MD, patrmorales@hotmail.com
Contact information
Scientific
Avenida de Los Quiñones 2. Portal G.
San Sebastián de Los Reyes
Madrid
28702
Spain
 ORCID ID |
0000-0002-0765-132X |
|---|---|
| Phone | +34 620296088 |
| pmoralesm.hdoc@salud.madrid.org |
Public
Avenida de Los Quiñones 2. Portal G
San Sebastián de Los Reyes
Madrid
28702
Spain
| Phone | +34 620296088 |
|---|---|
| patrmorales@hotmail.com |
Study information
| Study design | Single-centre interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 40580_PIS_v2_01Feb2019.pdf |
| Scientific title | Clinical and functional results of screws and TighRope Knotless device in the treatment of syndesmosis acute injuries: a randomized controlled trial |
| Study objectives | New-generation suture button device (TighRope Knotless) would provide similar results as screw fixation in syndesmosis injuries. |
| Ethics approval(s) | Approved 28/03/2019, Ethics committee of the University Hospital LA PAZ (P.º de la Castellana, 261, 28046 Madrid, Spain; +34 91 727 75 30; secretariatecnica@idipaz.es), ref: 5242 |
| Health condition(s) or problem(s) studied | Treatment of syndesmosis injury |
| Intervention | During surgery, once bone fractures have been fixed, the lesion of syndesmosis is verified by performing an external rotation stress test with the radiological study. If the patient suffers a syndesmosis injury, we open a randomization envelope and treat the injury with the corresponding implant: screw or tighrope. All patients in both treatment groups are treated with a splint postoperatively for two weeks. Afterwards, mobilization without load is allowed for a month and then progressive load begins. Until six months after surgery, impact sports activities are not authorized. All patients are reviewed two weeks after the intervention, one month, and at 3,6 and 12 months. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | TighRope Knotless |
| Primary outcome measure | 1. Pain is measured using Visual Analogue Scale (VAS) at 3, 6 and 12 months 2. Functional outcome is measured using AOFAS Scale and Olerud-Molander scale at 3, 6 and 12 months |
| Secondary outcome measures | 1. Ankle range motion measured using manual goniometer at 3, 6 and 12 months 2. Syndesmosis reduction measured usind rx at 3, 6 and 12 months and CT at baseline 3. Complications are collected during follow-up |
| Overall study start date | 28/03/2019 |
| Completion date | 30/11/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 50 patients will be treated with TighRope Knotless device and 50 patients with screws depending on the outcome of the randomization (sealed opaque envelopes) |
| Key inclusion criteria | 1. Patients over 16 years all with physis closed 2. Patients with acute isolated syndesmosis disruption and patients with ankle fracture associated with syndesmosis disruption |
| Key exclusion criteria | 1. Patients with physis opened 2. Patients with previus injuries about ankle 3. Patients unable to perform postoperative treatment adequately |
| Date of first enrolment | 01/04/2019 |
| Date of final enrolment | 30/09/2023 |
Locations
Countries of recruitment
- Spain
Study participating centre
San Sebastián de los Reyes
Madrid
28702
Spain
Sponsor information
Hospital/treatment centre
Paseo de Europa, 34
San Sebastián de Los Reyes
Madrid
28702
Spain
| Phone | +34 911 91 40 00 |
|---|---|
| macarena.vivar@salud.madrid.org | |
| Website | https://www.comunidad.madrid/hospital/infantasofia/ |
"ROR" |
https://ror.org/05dfzd836 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planed publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository All the data will be collected by specialists of the Foot and Ankle Unit of Infanta Sofía University Hospital. A double dissociated database will be created in Excel format with the function of safeguarding the confidentiality of patients. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2 | 01/02/2019 | 01/11/2021 | No | Yes |
Additional files
Editorial Notes
01/11/2021: Trial's existence confirmed by Ethics Committee of University Hospital La Paz
