scholarly journals 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 ◽  
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

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

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.

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

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 ◽  
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 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.

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

Injury ◽  
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

scholarly journals Preferences for everyday living inventory (PELI): study protocol for piloting a culture-sensitive and setting-specific translated instrument in German care settings (PELI-D)

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e030268
Author(s):  
Tobias Ingo Stacke ◽  
Johannes Michael Bergmann ◽  
Armin Michael Ströbel ◽  
René Müller-Widmer ◽  
Daniel Purwins ◽  
...  
Keyword(s):  
Pilot Study ◽  
Older People ◽  
Study Protocol ◽  
Personal Information ◽  
Care Process ◽  
Internal Quality ◽  
Care Practice ◽  
Individual Preferences ◽  
Need Of Care ◽  
Everyday Living

IntroductionRegardless of the healthcare setting, person-centred care and its implementation in caring for older people are a central issue for those who are responsible as professional caregivers and for those in need of care within the care process. Both aspects encompass the possibility of recognising personal preferences. To provide person-centred care, professional caregivers need to know about the individual preferences of the persons being cared for. Therefore, the PELI (an acronym for ‘Preferences for Everyday Living Inventory’) instrument was developed at the Polisher Research Institute (USA) for the systematic recording of individual preferences of older people in need of care. There is currently no comparable instrument available in the German language.MethodsAs part of the proposed project PELI-D, all versions of the original PELI instrument (nursing home version) were (1) culture-sensitively translated into German and will be (2) examined in a pilot study for their reliability, feasibility and practicability. For the project PELI-D, we worked together with our practice partners in Germany (Diaconia and Caritas in North Rhine-Westphalia) and collaborated with our partners in the USA who developed the PELI instrument. This study protocol focuses on the pilot study, which will be conducted by the German Center for Neurodegenerative Diseases (DZNE) (site Witten).Ethics and disseminationThis study was approved by the internal quality control committee of the DZNE (ID number: WI029 PELI-D) and by the ethics committee of the German Society of Nursing Science Duisburg branch office (ID number: 18-010). All personal information will be deidentified with a specific identification code and stored in a secured location apart from the rest of the study data. Only qualified and study-related staff will be allowed access to the data. The results of the study will be distributed nationally and internationally through peer-reviewed journals, conferences and journals for nursing care practice.

scholarly journals Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 12: Pedicle screw fixation as an adjunct to posterolateral fusion

2014 ◽  
Vol 21 (1) ◽  
pp. 75-78 ◽  
Author(s):  
Michael W. Groff ◽  
Andrew T. Dailey ◽  
Zoher Ghogawala ◽  
Daniel K. Resnick ◽  
William C. Watters ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Clinical Outcome ◽  
Pedicle Screw ◽  
Chronic Low Back Pain ◽  
Screw Fixation ◽  
Lumbar Fusion ◽  
Pedicle Screw Fixation ◽  
Controlled Study ◽  
Low Back

The utilization of pedicle screw fixation as an adjunct to posterolateral lumbar fusion (PLF) has become routine, but demonstration of a definitive benefit remains problematic. The medical evidence indicates that the addition of pedicle screw fixation to PLF increases fusion rates when assessed with dynamic radiographs. More recent evidence, since publication of the 2005 Lumbar Fusion Guidelines, suggests a stronger association between radiographic fusion and clinical outcome, although, even now, no clear correlation has been demonstrated. Although several reports suggest that clinical outcomes are improved with the addition of pedicle screw fixation, there are conflicting findings from similarly classified evidence. Furthermore, the largest contemporary, randomized, controlled study on this topic failed to demonstrate a significant clinical benefit with the use of pedicle screw fixation in patients undergoing PLF for chronic low-back pain. This absence of proof should not, however, be interpreted as proof of absence. Several limitations continue to compromise these investigations. For example, in the majority of studies the sample size is insufficient to detect small increments in clinical outcome that may be observed with pedicle screw fixation. Therefore, no definitive statement regarding the efficacy of pedicle screw fixation as a means to improve functional outcomes in patients undergoing PLF for chronic low-back pain can be made. There appears to be consistent evidence suggesting that pedicle screw fixation increases the costs and complication rate of PLF. High-risk patients, including (but not limited to) patients who smoke, patients who are undergoing revision surgery, or patients who suffer from medical conditions that may compromise fusion potential, may appreciate a greater benefit with supplemental pedicle screw fixation. It is recommended, therefore, that the use of pedicle screw fixation as a supplement to PLF be reserved for those patients in whom there is an increased risk of nonunion when treated with only PLF.

scholarly journals Pilot study on increased adherence to physical activity on prescription (PAP) through mindfulness: study protocol

Trials ◽  
2018 ◽  
Vol 19 (1) ◽  
Author(s):  
Peter Nymberg ◽  
Eva Ekvall Hansson ◽  
Emelie Stenman ◽  
Susanna Calling ◽  
Kristina Sundquist ◽  
...  
Keyword(s):  
Physical Activity ◽  
Pilot Study ◽  
Study Protocol
Sign in / Sign up

Export Citation Format

Share Document