Background: Ankle sprains and fractures are most common injuries in orthopedic and trauma surgery. The concurrent occurrence of syndesmosis ruptures in these injuries represents a more complex problem, as they often remain undetected. A proper and accurate treatment of isolated injuries of the syndesmosis is necessary to avoid long-term consequences. The most popular treatment option is a static screw fixation and the newly developed dynamic TightRope® (Arthrex, Naples, FL, USA). The aim of this study is to compare gait analysis, clinical and radiographic outcome after stabilization of an acute syndesmosis rupture with either a static implant (a 3.5mm metallic screw) or a dynamic device (TightRope®).
Methods: This prospective, randomized, controlled, clinical non-inferiority trial will be carried out at the Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg. Full-aged patients, who suffer from an acute syndesmosis rupture and who are undergoing surgery at our trauma center will be included in our study. The patients will be randomized to the different treatment options (screw fixation or “TightRope®”). Subsequent to the surgical treatment, all patients will receive the same standardized follow-up procedures including a gait analysis and MRI of the ankle at 6 months follow-up. The primary endpoint of the study is the successful healing of the syndesmosis and biomechanical investigation with gait analysis.
Discussion: The results of the gait analysis from the current study will help to impartially and reliably evaluate the clinical and biomechanical outcome of both treatment options of acute syndesmosis ruptures. We hypothesize that the dynamic fixation provides an equivalent or better biomechanical, clinical and radiographic outcome in comparison to the screw fixation.
Trial registration: German Clinical Trials Register (DRKS), ID: DRKS00013562, registered on 07.12.2017.
Figure 1
Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
Loading...
On 02 Jul, 2020
On 23 Jun, 2020
Received 09 Jun, 2020
On 08 Jun, 2020
Invitations sent on 07 Jun, 2020
On 26 May, 2020
On 25 May, 2020
On 24 May, 2020
Received 21 May, 2020
Invitations sent on 18 May, 2020
On 18 May, 2020
On 16 May, 2020
On 15 May, 2020
On 13 May, 2020
Received 06 Apr, 2020
On 02 Apr, 2020
On 16 Mar, 2020
Received 16 Mar, 2020
Invitations sent on 14 Mar, 2020
On 14 Mar, 2020
Received 14 Mar, 2020
On 04 Mar, 2020
On 03 Mar, 2020
Posted 03 Dec, 2019
On 04 Feb, 2020
Received 09 Jan, 2020
On 06 Jan, 2020
Received 17 Dec, 2019
On 09 Dec, 2019
Invitations sent on 08 Dec, 2019
On 04 Dec, 2019
On 29 Nov, 2019
On 16 Nov, 2019
On 02 Jul, 2020
On 23 Jun, 2020
Received 09 Jun, 2020
On 08 Jun, 2020
Invitations sent on 07 Jun, 2020
On 26 May, 2020
On 25 May, 2020
On 24 May, 2020
Received 21 May, 2020
Invitations sent on 18 May, 2020
On 18 May, 2020
On 16 May, 2020
On 15 May, 2020
On 13 May, 2020
Received 06 Apr, 2020
On 02 Apr, 2020
On 16 Mar, 2020
Received 16 Mar, 2020
Invitations sent on 14 Mar, 2020
On 14 Mar, 2020
Received 14 Mar, 2020
On 04 Mar, 2020
On 03 Mar, 2020
Posted 03 Dec, 2019
On 04 Feb, 2020
Received 09 Jan, 2020
On 06 Jan, 2020
Received 17 Dec, 2019
On 09 Dec, 2019
Invitations sent on 08 Dec, 2019
On 04 Dec, 2019
On 29 Nov, 2019
On 16 Nov, 2019
Background: Ankle sprains and fractures are most common injuries in orthopedic and trauma surgery. The concurrent occurrence of syndesmosis ruptures in these injuries represents a more complex problem, as they often remain undetected. A proper and accurate treatment of isolated injuries of the syndesmosis is necessary to avoid long-term consequences. The most popular treatment option is a static screw fixation and the newly developed dynamic TightRope® (Arthrex, Naples, FL, USA). The aim of this study is to compare gait analysis, clinical and radiographic outcome after stabilization of an acute syndesmosis rupture with either a static implant (a 3.5mm metallic screw) or a dynamic device (TightRope®).
Methods: This prospective, randomized, controlled, clinical non-inferiority trial will be carried out at the Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg. Full-aged patients, who suffer from an acute syndesmosis rupture and who are undergoing surgery at our trauma center will be included in our study. The patients will be randomized to the different treatment options (screw fixation or “TightRope®”). Subsequent to the surgical treatment, all patients will receive the same standardized follow-up procedures including a gait analysis and MRI of the ankle at 6 months follow-up. The primary endpoint of the study is the successful healing of the syndesmosis and biomechanical investigation with gait analysis.
Discussion: The results of the gait analysis from the current study will help to impartially and reliably evaluate the clinical and biomechanical outcome of both treatment options of acute syndesmosis ruptures. We hypothesize that the dynamic fixation provides an equivalent or better biomechanical, clinical and radiographic outcome in comparison to the screw fixation.
Trial registration: German Clinical Trials Register (DRKS), ID: DRKS00013562, registered on 07.12.2017.
Figure 1
Figure 2
Loading...