Perioperative Case Series: Qualitative Evaluation of Gait Cycle and Ground in Knee Arthroplasty Patients
Condition: Gait, Unsteady
MeSH terms: Gait Disorders, Neurologic
Study type: Observational

Summary: 
      Gait analysis is a quick and powerful tool with a wide range of clinical applications in
      various fields. However, due to the expensive and highly specialized equipment required, gait
      studies are mostly limited to academic research centers and small sample sizes and no
      large-scale, randomized controlled trials have been performed. Several authors have proposed
      inexpensive accelerometer-based systems to remedy this situation. Through mathematic
      transformation they adequately measure step time and length. With these systems however only
      temporal spatial gait parameters can be recorded; kinetic gait parameters, such as ground
      reaction force, cannot be measured. As these kinetic parameters are important for clinical
      studies, especially in fracture and rehabilitation research different methods are needed. Its
      availability is mainly limited to research centers, conventional gait analysis is further
      hindered by its stationarity and that it only allows momentary views of the patient's gait in
      a confined research environment. Even smaller, wearable systems have to be attached to an
      external apparatus, or are limited by their battery capacity, data storage and other device
      specific factors. Furthermore, the use of these systems is at an early clinical stage and
      their full potential not yet developed. As most disease processes are continuous, tools with
      long-term, continuous measuring capabilities are needed. For this reason a new
      pressure-measuring insole with built in battery and data storage was developed in cooperation
      with the AO Foundation(AO Foundation, Davos, Switzerland). The system offers complete
      independence from any external measures for up to 4 weeks and monitors a patient step during
      this time.

      The purpose of this pilot study is to investigate which how TKA arthroplasty may impact gait
      during early and medium term rehabilitation phase. This will be done through the use of the
      OpenGo Sensor Insole (Moticon GmbH).
    

Detailed description: 
      Advanced degenerative arthropathies of the knee ultimately manifest as pain and a loss of
      function leading to impaired gait and activity. Total knee arthroplasty (TKA) is a procedure
      that aim to eliminate pain, restore the function of the joint and ultimately improve the
      ability of the patient to move and live an active life. TotalKneeArthroplasty has a history
      of success, but as the orthopedic and healthcare sectors evolve, a greater level of scrutiny
      and expectation for success will be applied to surgeons and device makers alike. In response
      to these elevated levels of scrutiny and expectation more advanced methods will likely be
      required to better capture and understand how a TotalKneeArthroplasty impacts patient
      function both on an individual, patient by patient, basis as well as on device design and
      surgical technique basis.

      The present study is aimed at performing a preliminary evaluation to provide:

      More advanced insight into a patient's functional recovery and rehabilitation with the
      potential for phisician's to intervene earlier and with greater specificity to any challenges
      encountered by the patient Objective evidence of the quality and value of the intervention on
      an individualized basis. Study objectives Any change in gait as a result of arthroplasty and
      dynamics of gait recovery during acute recovery and rehabilitation timeframe. Outcome
      measures will be gait cycle and ground: foot interaction dynamics which will be observed
      longitudinally and compared to the healthy contralateral limb (ground: foot interaction
      dynamics) as well literature data (gait cycle).

      Primary objective:Evaluation of gait cycle and ground in primary TotalKneeArthroplasty
      patients compared to the healthy contralateral limb.

      Secondary objectives:Easy of use. Qualitative user (Phisician and patient) feedback on
      experience using and wearing the insoles Study design:This is, single arm, prospective,
      single center, pilot study to measure the pre-operative and post-operative gait and ground:
      foot interaction dynamics of 6 subjects who are undergoing TotalKneeArthroplasty .

      Data that will be collected at baseline (pre-op) besides the standard clinical data
      (VisualAnalogueScale, KneeSocietyScore SatisfactionForm-12, Knee Injury and Osteoarthritis
      Outcome Score(KOOS)) include: gait and ground: foot interaction dynamics during a prescribed
      in clinic activity as well as during activities of daily living.

      Data that will be collected about the clinical follow-up include: gait and ground: foot
      interaction dynamics during a prescribed in clinic activity as well as during activities of
      daily living; user feedback regarding their experience using and wearing the insoles.

      Total study duration for study participants will be 6 months with follow-up visits planned
      at: daily until discharge, 1 week, 2 weeks, 3 weeks, 3 months and 6 months. Full enrollement
      is estimated to require 1 months, therefore the total study duration is expected to be 7
      months.

      Subjects will be included in 1 Italian site. Data and user feedback will be analyzed
      continuously as they become available throughout the study period.

      Patients selection:Once a subject has completed the informed consent procedure and signed the
      Informed Consent Form, the PI or delegated study research staff can complete the screening
      process with the subject. All potential subjects who undergo the screening process will be
      documented on a Screening and Enrollment Log, on which reasons for exclusion from or denial
      to participate should be noted.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients affected by degenerative gonarthrosis who need a TKA in one of the two Knees
      
Keywords: gait cycle; knee arthroplasty; wearable insole