Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-07-01 @ 10:18 PM
Study NCT ID:
NCT03356951
Status:
COMPLETED
Last Update Posted:
2017-12-04
First Post:
2017-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gait Analysis Following Total Ankle Replacement and Subtalar Fusion
Sponsor:
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Organization:
Study Overview
Official Title:
Analysis of Patients Who Underwent Ankle Replacement and Simultaneous Subtalar Fusion by Biomechanical and Clinical Evaluation
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Subtalar fusion is commonly performed in post-traumatic subtalar osteoarthritis, rheumatoid arthritis, posterior tibial tendon dysfunction, tarsal coalition and primary subtalar osteoarthritis. Patients with osteoarthritis or severe dysfunction involving both the ankle and the subtalar joint may benefit from an tibiotalocalcaneal fusion (TTC) or an ankle replacement and subtalar fusion. With the development of new prosthetic designs and of surgical techniques, total ankle replacements (TAR) became a reasonable alternative to fusion with functional and quality of life improvements. A gait analysis of patients that underwent TAR and simultaneous subtalar fusion allows to study with precision and reliability the ankle range of motion (ROM). On the contrary, in healthy subjects or in patients that underwent isolated TAR this is not possible because the ankle ROM is influenced by the ROM of the subtalar joint in such a way that it is not possible to analyze the two joints separately. Also, excluding the role of the subtalar joint, it is possible to accurately analyze and compare the consequences on ankle kinematics of two different prosthetic designs.
Detailed Description:
Patients who previously have underwent TAR and simultaneous subtalar fusion are retrospectively reviewed. Minimum follow-up after the surgery is 12 months.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: