New App for Monitoring Postoperative Pain in Total Ankle Replacement

NCT03777072 | Unknown

• 1 other identifier: ARP1
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Osteoarthritis; Pain, Postoperative

Keywords

Total Ankle Replacement; Pain Measurement

Outcome Measures

Primary Outcomes (3)

• Pain area index

  Quantifies the percentage of pain area with respect to the total body area in the considered plane

  Through study completion, an average of 18 months

• VAS score

  Continuous value ranging from 0 (minimum) to 10 (maximum), indicating the pain level reported by patient.

  Through study completion, an average of 18 months

• Presence of side effects

  Dichotomic variable. Equal to 1 in case of reported side effects, 0 otherwise.

  Through study completion, an average of 18 months

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing first implant of total ankle replacement

You may qualify if:

• 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

You may not qualify if:

• previous ankle replacement implants or ipsilateral ankle arthrodesis

Sponsors & Collaborators

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

Study Sites (1)

Irccs Istituto Ortopedico Galeazzi

Milan, Milano, 20156, Italy

RECRUITING

Related Publications (6)

• Boudreau SA, Badsberg S, Christensen SW, Egsgaard LL. Digital Pain Drawings: Assessing Touch-Screen Technology and 3D Body Schemas. Clin J Pain. 2016 Feb;32(2):139-45. doi: 10.1097/AJP.0000000000000230.

  PMID: 25756558 BACKGROUND

• Campbell WI, Lewis S. Visual analogue measurement of pain. Ulster Med J. 1990 Oct;59(2):149-54.

  PMID: 2278111 BACKGROUND

• Haeseler G, Schaefers D, Prison N, Ahrens J, Liu X, Karch A. Combatting pain after orthopedic/trauma surgery- perioperative oral extended-release tapentadol vs. extended-release oxycodone/naloxone. BMC Anesthesiol. 2017 Jul 11;17(1):91. doi: 10.1186/s12871-017-0383-6.

  PMID: 28693439 BACKGROUND

• Hartrick C, Van Hove I, Stegmann JU, Oh C, Upmalis D. Efficacy and tolerability of tapentadol immediate release and oxycodone HCl immediate release in patients awaiting primary joint replacement surgery for end-stage joint disease: a 10-day, phase III, randomized, double-blind, active- and placebo-controlled study. Clin Ther. 2009 Feb;31(2):260-71. doi: 10.1016/j.clinthera.2009.02.009.

  PMID: 19302899 BACKGROUND

• Matthews M, Rathleff MS, Vicenzino B, Boudreau SA. Capturing patient-reported area of knee pain: a concurrent validity study using digital technology in patients with patellofemoral pain. PeerJ. 2018 Mar 8;6:e4406. doi: 10.7717/peerj.4406. eCollection 2018.

  PMID: 29568700 BACKGROUND

• Nett MP. Postoperative pain management. Orthopedics. 2010 Sep;33(9 Suppl):23-6. doi: 10.3928/01477447-20100722-60.

  PMID: 20839719 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Federico Federico, MD

  IRCCS Istituto Ortopedico Galeazzi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tito Bassani, PhD

CONTACT

+390266214939; tito.bassani@grupposandonato.it

Federico Usuelli, MD

CONTACT

+39‭3357351838‬; fusuelli@gmail.com

Study Design

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

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 17, 2018
• Study Start: December 12, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: December 17, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)