Perioperative Case Series: Qualitative Evaluation of Gait Cycle and Ground in Knee Arthroplasty Patients

NCT04268680 | Completed DMC

• 1 other identifier: OpenGO
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Gait, Unsteady

Keywords

gait cycle; knee arthroplasty; wearable insole

Outcome Measures

Primary Outcomes (1)

• Perioperative Case Series: clinical evaluation of gait cycle and ground in Knee arthroplasty patients

  Evaluation of gait cycle and ground in primary TKA patients compared to the healthy contralateral limb.

  baseline to 3 month

Secondary Outcomes (1)

• Perioperative Case Series: qualitative evaluation of gait cycle and ground in Knee arthroplasty patients

  baseline to 3 month

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by degenerative gonarthrosis who need a TKA in one of the two Knees

You may qualify if:

• primary TKA
• years of age (included)
• skeletally mature
• willing and able to participate in required pre-op and follow-up visits at the investigational site and to complete study procedures and questionnaires
• consented to participating in the study by signing the IRB/EC approved informed consent form
• BMI \<32

You may not qualify if:

• symptomatic/debilitating co-commitant arthropathy of non-operative joints (e.g. a TKA patient cannot have advanced arthritis of the contralateral knee or ipsilateral hip/ankle) that would impede or otherwise confuse the peri-operative measurement of gait.
• Significant comorbidities that would impede the patients ability to participate in standard recovery and rehabilitation

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

Istituto Ortopedico Galeazzi

Milan, 20161, Italy

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michele Ulivi, Dr

  IRCCS Istituto Ortopedico GaleazziMilano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: November 7, 2017
• Primary Completion: January 9, 2018
• Study Completion: June 8, 2018
• Last Updated: April 24, 2020

Record last verified: 2020-02

Locations

IT (1)