Differences in gait analysis and clinical outcome after TightRope® or screw fixation in acute syndesmosis rupture: Study protocol for a prospective randomized pilot study

Abstract 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 trial

10.21203/rs.2.18010/v2 ◽

2020 ◽

Author(s):

Julian Doll ◽

Stefan Waizenegger ◽

Thomas Bruckner ◽

Gerhard Schmidmaier ◽

Sebastian I. Wolf ◽

...

Keyword(s):

Gait Analysis ◽

Screw Fixation ◽

Treatment Options ◽

Cartilage Damage ◽

Trauma Surgery ◽

University Hospital ◽

Controlled Clinical Trial ◽

Radiographic Outcome ◽

Cord Injury

Abstract 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 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.

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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

10.21203/rs.2.18010/v3 ◽

2020 ◽

Author(s):

Julian Doll ◽

Stefan Waizenegger ◽

Thomas Bruckner ◽

Gerhard Schmidmaier ◽

Sebastian I. Wolf ◽

...

Keyword(s):

Pilot Study ◽

Gait Analysis ◽

Screw Fixation ◽

Treatment Options ◽

Cartilage Damage ◽

Trauma Surgery ◽

Controlled Clinical Trial ◽

Radiographic Outcome ◽

Cord Injury

Abstract 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.

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Differences in gait analysis and clinical outcome after TightRope® or screw fixation in acute syndesmosis rupture: a prospective randomized trial

10.21203/rs.2.18010/v1 ◽

2019 ◽

Author(s):

Julian Doll ◽

Stefan Waizenegger ◽

Thomas Bruckner ◽

Gerhard Schmidmaier ◽

Sebastian I. Wolf ◽

...

Keyword(s):

Gait Analysis ◽

Screw Fixation ◽

Treatment Options ◽

Trauma Surgery ◽

University Hospital ◽

Ankle Sprains ◽

Radiographic Outcome ◽

Aged Patients ◽

Cord Injury

Abstract 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.

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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

Trials ◽

10.1186/s13063-020-04550-5 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Julian Doll ◽

Stefan Waizenegger ◽

Thomas Bruckner ◽

Gerhard Schmidmaier ◽

Sebastian I. Wolf ◽

...

Keyword(s):

Pilot Study ◽

Clinical Outcome ◽

Gait Analysis ◽

Study Protocol ◽

Screw Fixation

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Assessment of muscular perfusion after oral intake of pre-workout nitric-oxide stimulating supplements by Contrast-Enhanced Ultrasound (CEUS). Study protocol for a placebo-controlled, randomized cross-over trial in healthy young males

10.21203/rs.3.rs-18728/v1 ◽

2020 ◽

Author(s):

Julian Doll ◽

Franziska Bürkle ◽

Arndt Neide ◽

Stefanos Tsitlakidis ◽

Thomas Bruckner ◽

...

Keyword(s):

Nitric Oxide ◽

Imaging Modality ◽

Trauma Surgery ◽

Oral Intake ◽

University Hospital ◽

Contrast Enhanced Ultrasound ◽

Double Blind ◽

Male Athletes ◽

Contrast Enhanced ◽

Cord Injury

Abstract Background The market for dietary supplements in the sports sector has been growing rapidly for several years, though there is still lacking evidence regarding their claimed benefits. One group is that of nitric oxide increasing supplements, so-called "NO-boosters", which are claimed to improve the supply of oxygen and nutrients to the muscle by enhancing vasodilation. The aim of this study was to investigate three of these supplements in healthy male athletes for their muscle perfusion-enhancing potential using contrast-enhanced ultrasound (CEUS).Methods This placebo-controlled, double-blind, randomized cross-over trial will be carried out at the Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg. Three commercial NO enhancing products including 300 mg of the specific green tea extract VASO6™ and a combination of 8 g L-citrulline malate and 3 g L-arginine hydrochloride will be examined for their potential to increase muscular perfusion in 30 male athletes between 18 and 40 years and will be compared with a placebo. On each of the three appointments CEUS of the dominant biceps muscle will be performed at rest and after a standardized resistance training. Every athlete receives each of the three supplements once after a wash-out period of at least one week. Perfusion will be quantified via VueBox® quantification software. The results of CEUS perfusion measurements will be compared intra- and interindividually and correlated with clinical parameters.Discussion The results of this study may help to establish CEUS as a suitable imaging modality for the evaluation of potentially vasodilatory drugs in the field of sports. Other supplements could also be evaluated in this way to verify the content of their advertising claims.Trial registration German Clinical Trials Register (DRKS), ID: DRKS00016972, registered on 25.03.2019.

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The Effects of Hand-bike Exercise Equipment in People with Spinal Cord Injury: A pilot study : A Pilot Study

Korean Journal of Sports Science ◽

10.35159/kjss.2018.06.27.3.983 ◽

2018 ◽

Vol 27 (3) ◽

pp. 983-991

Author(s):

So-Eun Lee ◽

Dong-Il Kim

Keyword(s):

Spinal Cord ◽

Spinal Cord Injury ◽

Pilot Study ◽

Cord Injury ◽

Exercise Equipment

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Corrigendum to ‘3D - Navigated percutaneous screw fixation of pelvic ring injuries - a pilot study’ [Injury 51S3 (2020) S28 – S33]

Injury ◽

10.1016/j.injury.2021.02.011 ◽

2021 ◽

Author(s):

Michela Florio ◽

Luigi Capasso ◽

Alessandro Olivi ◽

Carla Vitiello ◽

Antonio Leone ◽

...

Keyword(s):

Pilot Study ◽

Screw Fixation ◽

Pelvic Ring ◽

Percutaneous Screw Fixation ◽

Pelvic Ring Injuries

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“Proximalization is Advancement”—Zone 3 Frozen Elephant Trunk vs Zone 2 Frozen Elephant Trunk: A Literature Review

Vascular and Endovascular Surgery ◽

10.1177/15385744211002493 ◽

2021 ◽

pp. 153857442110024

Author(s):

Rozina Yasmin Choudhury ◽

Kamran Basharat ◽

Syeda Anum Zahra ◽

Tien Tran ◽

Lara Rimmer ◽

...

Keyword(s):

Spinal Cord ◽

Spinal Cord Injury ◽

Surgical Treatment ◽

Literature Review ◽

Treatment Options ◽

Frozen Elephant Trunk ◽

Elephant Trunk ◽

Descending Aorta ◽

Cord Injury ◽

Aortic Pathologies

Over the decades, the Frozen Elephant Trunk (FET) technique has gained immense popularity allowing simplified treatment of complex aortic pathologies. FET is frequently used to treat aortic conditions involving the distal aortic arch and the proximal descending aorta in a single stage. Surgical preference has recently changed from FET procedures being performed at Zone 3 to Zone 2. There are several advantages of Zone 2 FET over Zone 3 FET including reduction in spinal cord injury, visceral ischemia, neurological and cardiovascular sequelae. In addition, Zone 2 FET is a technically less complicated procedure. Literature on the comparison between Zone 3 and Zone 2 FET is scarce and primarily observational and anecdotal. Therefore, further research is warranted in this paradigm to substantiate current surgical treatment options for complex aortic pathologies. In this review, we explore literature surrounding FET and the reasons for the shift in surgical preference from Zone 3 to Zone 2.

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COT-13 Current situation and problems of cancer genomic profiling test in Kyoto University Hospital

Neuro-Oncology Advances ◽

10.1093/noajnl/vdaa143.099 ◽

2020 ◽

Vol 2 (Supplement_3) ◽

pp. ii22-ii22

Author(s):

Yoshiki Arakawa ◽

Junko Suga ◽

Yukinori Terada ◽

Kohei Nakajima ◽

Masahiro Tanji ◽

...

Keyword(s):

Treatment Options ◽

Insurance Coverage ◽

Germline Mutations ◽

University Hospital ◽

Genomic Profiling ◽

Test Results ◽

Final Test ◽

First Time ◽

To Receive ◽

Secondary Finding

Abstract Objective: Kyoto University Hospital has introduced the cancer genomic profiling tests, Oncoprime in 2015, Guardant360 in 2018, which are not under insurance coverage, FoundationOne CDx(F1CDx) and OncoGuide NCC Oncopanel system(NCC OP) in 2019, which received approval for insurance coverage for the first time in Japan. We investigated the results of cancer genomic profiling test under insurance coverage in our hospital. Methods: A special facility for the cancer genomic profiling tests was produced. To perform the cancer genomic profiling test, an outpatient must visit the facility three times (learning, ordering of the test, and getting the results). The expert panels decide the final test results and treatment options with the all information of the patients. Results: From November 2019 to March 2020, 51 and 9 patients were tested with F1CDx and NCC OP, respectively. 16 patients (31%) of F1CDX and 2 patients (22%) of NCC OP got treatment recommendations from the expert panels. However, only 5 patients (9.8%) of F1CDX and 1 patient (11%) of NCC OP received the treatments. The secondary finding suspecting germline mutations was found in 8 patients of F1CDX. Conclusion: After the approval the cancer genomic profiling tests with insurance coverage in Japan, it becomes easy for the patients to perform the test and get the genetic information of the tumor. However, it remains not easy to receive the recommended drugs because of several limitations of their usages.

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