Ankle Osteoarthritis Clinical Trial
Official title:
Evaluation of the Relation Between the Rotation Angle of the Talar Component and the Antero-medial Pain in Patients Underwent Total Ankle Replacement, at Least One Year After Surgery
NCT number | NCT03772236 |
Other study ID # | ARP2 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 4, 2018 |
Est. completion date | June 30, 2020 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - previous intervention of first implant of total ankle replacement, with at least 12 months of follow up and maximum 36 months Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Irccs Istituto Ortopedico Galeazzi | Milan | Milano |
Lead Sponsor | Collaborator |
---|---|
Istituto Ortopedico Galeazzi |
Italy,
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. — View Citation
Manzi L, Villafañe 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. 2017 Nov 8. pii: S1268-7731(17)31308-5. doi: 10.1016/j.fas.2017.10.009. [Epub ahead of print] — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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