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Trial record 75 of 674 for:    applied AND web-

New App for Monitoring Postoperative Pain in Total Ankle Replacement

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ClinicalTrials.gov Identifier: NCT03777072
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi

Brief Summary:
The study evaluates a novel web-based application for monitoring the postoperative pain in patients undergoing total ankle replacement, from preoperative condition to 30 days follow-up. The indexes provided by the app in terms of percentages of pain areas are compared with that obtained with traditional visual analogue scale. Moreover, the relation between the percentage of pain area and the presence of side effects of the intervention are compared as well.

Condition or disease
Ankle Osteoarthritis Pain, Postoperative

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a Novel Web-based Application for Monitoring Postoperative Pain in Patients Underwent Total Ankle Replacement
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Pain area index [ Time Frame: Through study completion, an average of 18 months ]
    Quantifies the percentage of pain area with respect to the total body area in the considered plane

  2. VAS score [ Time Frame: Through study completion, an average of 18 months ]
    Continuous value ranging from 0 (minimum) to 10 (maximum), indicating the pain level reported by patient.

  3. Presence of side effects [ Time Frame: Through study completion, an average of 18 months ]
    Dichotomic variable. Equal to 1 in case of reported side effects, 0 otherwise.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects undergoing first implant of total ankle replacement
Criteria

Inclusion Criteria:

  • age from 18 to 60 years
  • ankle arthrosis grade 3 or 4, according to Kellgren-Lawrence classification
  • subject undergoing first implant of total ankle replacement
  • skeletal maturity
  • signed informed consent

Exclusion Criteria:

  • previous ankle replacement implants or ipsilateral ankle arthrodesis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777072


Contacts
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Contact: Tito Bassani, PhD +390266214939 tito.bassani@grupposandonato.it
Contact: Federico Usuelli, MD +39‭3357351838‬ fusuelli@gmail.com

Locations
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Italy
Irccs Istituto Ortopedico Galeazzi Recruiting
Milan, Milano, Italy, 20156
Contact: Federico Usuelli, MD    +39‭3357351838‬    fusuelli@gmail.com   
Principal Investigator: Federico Usuelli, MD         
Sponsors and Collaborators
Istituto Ortopedico Galeazzi
Investigators
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Principal Investigator: Federico Federico, MD IRCCS Istituto Ortopedico Galeazzi

Publications:
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Responsible Party: Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier: NCT03777072     History of Changes
Other Study ID Numbers: ARP1
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Istituto Ortopedico Galeazzi:
Total Ankle Replacement
Pain Measurement

Additional relevant MeSH terms:
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Osteoarthritis
Pain, Postoperative
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms