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Study protocol
Julian Doll
UniversitatsKlinikum Heidelberg Department Orthopadie Unfallchirurgie und Paraplegiologie
Corresponding Author
ORCiD: https://orcid.org/0000-0002-8563-3493
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
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.
Keywords
syndesmosis rupture, TightRope®, syndesmotic screw fixation, gait analysis
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CURRENT STATUS: Published
Version 4
Posted 03 Jun, 2020
Published
On 02 Jul, 2020
No community comments so far
Editorial decision: Accept
On 23 Jun, 2020
Review #1 received
Received 09 Jun, 2020
Reviewer #1 agreed
On 08 Jun, 2020
Reviewers invited
Invitations sent on 07 Jun, 2020
Editor assigned
On 26 May, 2020
Submission checks complete
On 25 May, 2020
No comments provided
Editorial decision: Minor revision
On 24 May, 2020
Review #1 received
Received 21 May, 2020
Reviewers invited
Invitations sent on 18 May, 2020
Reviewer #1 agreed
On 18 May, 2020
Editor assigned
On 16 May, 2020
Submission checks complete
On 15 May, 2020
No comments provided
Editorial decision: Major revision
On 13 May, 2020
Review #3 received
Received 06 Apr, 2020
Reviewer #3 agreed
On 02 Apr, 2020
Reviewer #2 agreed
On 16 Mar, 2020
Review #2 received
Received 16 Mar, 2020
Reviewers invited
Invitations sent on 14 Mar, 2020
Reviewer #1 agreed
On 14 Mar, 2020
Review #1 received
Received 14 Mar, 2020
Editor assigned
On 04 Mar, 2020
Submission checks complete
On 03 Mar, 2020
No comments provided
Editorial decision: Major revision
On 04 Feb, 2020
Review #2 received
Received 09 Jan, 2020
Reviewer #2 agreed
On 06 Jan, 2020
Review #1 received
Received 17 Dec, 2019
Reviewer #1 agreed
On 09 Dec, 2019
Reviewers invited
Invitations sent on 08 Dec, 2019
Editor assigned
On 04 Dec, 2019
Submission checks complete
On 29 Nov, 2019
First submitted
On 16 Nov, 2019
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Subject Areas
Orthopedic Surgery
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Julian Doll
UniversitatsKlinikum Heidelberg Department Orthopadie Unfallchirurgie und Paraplegiologie
Corresponding Author
ORCiD: https://orcid.org/0000-0002-8563-3493
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 4
Posted 03 Jun, 2020
Published
On 02 Jul, 2020
No community comments so far
Editorial decision: Accept
On 23 Jun, 2020
Review #1 received
Received 09 Jun, 2020
Reviewer #1 agreed
On 08 Jun, 2020
Reviewers invited
Invitations sent on 07 Jun, 2020
Editor assigned
On 26 May, 2020
Submission checks complete
On 25 May, 2020
No comments provided
Editorial decision: Minor revision
On 24 May, 2020
Review #1 received
Received 21 May, 2020
Reviewers invited
Invitations sent on 18 May, 2020
Reviewer #1 agreed
On 18 May, 2020
Editor assigned
On 16 May, 2020
Submission checks complete
On 15 May, 2020
No comments provided
Editorial decision: Major revision
On 13 May, 2020
Review #3 received
Received 06 Apr, 2020
Reviewer #3 agreed
On 02 Apr, 2020
Reviewer #2 agreed
On 16 Mar, 2020
Review #2 received
Received 16 Mar, 2020
Reviewers invited
Invitations sent on 14 Mar, 2020
Reviewer #1 agreed
On 14 Mar, 2020
Review #1 received
Received 14 Mar, 2020
Editor assigned
On 04 Mar, 2020
Submission checks complete
On 03 Mar, 2020
No comments provided
Editorial decision: Major revision
On 04 Feb, 2020
Review #2 received
Received 09 Jan, 2020
Reviewer #2 agreed
On 06 Jan, 2020
Review #1 received
Received 17 Dec, 2019
Reviewer #1 agreed
On 09 Dec, 2019
Reviewers invited
Invitations sent on 08 Dec, 2019
Editor assigned
On 04 Dec, 2019
Submission checks complete
On 29 Nov, 2019
First submitted
On 16 Nov, 2019
Subject Areas
Orthopedic Surgery
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
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
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