Differences in gait analysis and clinical outcome after TightRope® or screw fixation in acute syndesmosis rupture: Study protocol for a prospective randomized pilot study
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 injuries of the syndesmosis, both isolated and combined with fractures, is necessary to avoid long-term consequences (chronic instability, cartilage damage and post-traumatic osteoarthritis). The most popular treatment option is a static screw fixation and the newly developed dynamic TightRope® (Arthrex, Naples, FL, USA).
The aim of this pilot study is to compare monitor ankle range of motion and maximum ankle power in gait as functional outcome parameters of instrumented gait analysis, as well as clinical and radiographic outcome for assessing the stabilization of acute syndesmosis rupture with either a static implant (a 3.5mm metallic screw) or a dynamic device (TightRope®).
Methods: This prospective, randomized, controlled, clinical trial will be carried out at the Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg. Adult patients, who suffer from an acute syndesmosis rupture, both isolated and in combination with fractures of the lateral malleolus (Weber C and Maisonneuve fractures) 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.
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Differences in gait analysis and clinical outcome after TightRope® or screw fixation in acute syndesmosis rupture: Study protocol for a prospective randomized pilot study
Posted 03 Jun, 2020
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
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 injuries of the syndesmosis, both isolated and combined with fractures, is necessary to avoid long-term consequences (chronic instability, cartilage damage and post-traumatic osteoarthritis). The most popular treatment option is a static screw fixation and the newly developed dynamic TightRope® (Arthrex, Naples, FL, USA).
The aim of this pilot study is to compare monitor ankle range of motion and maximum ankle power in gait as functional outcome parameters of instrumented gait analysis, as well as clinical and radiographic outcome for assessing the stabilization of acute syndesmosis rupture with either a static implant (a 3.5mm metallic screw) or a dynamic device (TightRope®).
Methods: This prospective, randomized, controlled, clinical trial will be carried out at the Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg. Adult patients, who suffer from an acute syndesmosis rupture, both isolated and in combination with fractures of the lateral malleolus (Weber C and Maisonneuve fractures) 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