Phi Angle and Antero-medial Pain in Total Ankle Replacement Follow-up

NCT03772236 | Unknown

• 1 other identifier: ARP2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates the relation between the rotational alignment of the talar component (phi angle) and the antero-medial ankle pain in patients underwent total ankle replacement, at least one year after surgery. Moreover, the study aims to define a range of the phi angle associated with a lower frequency of antero-medial pain.

Conditions

Ankle Osteoarthritis; Prostheses and Implants

Keywords

Total Ankle Replacement; Pain Measurement

Outcome Measures

Primary Outcomes (2)

• Phi angle

  Relative angle (measured in degrees) between the alignment of the talar component of the implant, and the axis passing through the second metatarsal bone, in the dorsoplantar plane.

  Through study completion, an average of 18 months

• Antero-medial ankle pain

  Sum of the antero and medial pain areas, measured as percentage with respect to the total body area in the considered plane.

  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

Patients undergoing follow-up examination at a third-level hospital after total ankle replacement

You may qualify if:

• previous intervention of first implant of total ankle replacement, with at least 12 months of follow up and maximum 36 months

You may not qualify if:

• more than 36 months from the surgery of first implant of total ankle replacement
• previous revision surgery of ankle prosthesis
• previous intervention of ankle disarthrodesis and ankle prosthesis implant

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 (5)

• 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

• Manzi L, Villafane JH, Indino C, Tamini J, Berjano P, Usuelli FG. Reliability of the Phi angle to assess rotational alignment of the talar component in total ankle replacement. Foot Ankle Surg. 2019 Apr;25(2):169-173. doi: 10.1016/j.fas.2017.10.009. Epub 2017 Nov 8.

  PMID: 29409284 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

• Roukis TS. The Salto Talaris XT Revision Ankle Prosthesis. Clin Podiatr Med Surg. 2015 Oct;32(4):551-67. doi: 10.1016/j.cpm.2015.06.019. Epub 2015 Jul 31.

  PMID: 26407741 BACKGROUND

• Saltzman CL, Tochigi Y, Rudert MJ, McIff TE, Brown TD. The effect of agility ankle prosthesis misalignment on the peri-ankle ligaments. Clin Orthop Relat Res. 2004 Jul;(424):137-42. doi: 10.1097/01.blo.0000132463.80467.65.

  PMID: 15241155 BACKGROUND

Study Officials

• Federico Usuelli, 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: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 11, 2018
• Study Start: December 4, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: December 14, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)