Follow-up of Patients With Talocalcaneal Coalitions

July 1, 2021 updated by: Peking University Third Hospital
The objective of this study was to develop a new classification system based on the articular facets involved to cover all coalitions and guide operative planning.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Patients were diagnosed with talocalcaneal coalition using a CT scan, between January 2009 and February 2021. We classified the coalition into four main types according to the shape and nature of the coalition: I, inferiorly overgrown talus or superiorly overgrown calcaneus; II, both talus and calcaneus overgrew; III, coalition with an accessory ossicle; (I-III types are non-osseous coalition) IV, complete osseous coalition. Then each type was further divided into three subtypes according to the articular facets involved. A, the coalition involving the anterior facets; M, the coalition involving the middle facets, and P, the coalition involving the posterior facets.

Study Type

Observational

Enrollment (Actual)

106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients that were diagnosed with talocalcaneal coalition using a CT scan, between January 2009 and February 2021.

Description

Inclusion Criteria:

  • Patients diagnosed as talocalcaneal coalition by CT or MRI at the outpatient
  • Underwent arthroscopic talocalcaneal coalition resection due to failure of conservative treatment

Exclusion Criteria:

  • The affected side underwent other foot and ankle operations
  • Combined with other ankle diseases
  • Refused to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CT
Time Frame: pre-surgery
computerized tomography scan
pre-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI
Time Frame: pre-surgery
magnetic resonance imaging
pre-surgery
AFOAS
Time Frame: pre-surgery, one year after sugery
he American Orthopaedic Foot & Ankle Society score
pre-surgery, one year after sugery
Tegner
Time Frame: pre-surgery, one year after sugery
the Tegner score
pre-surgery, one year after sugery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Qinwei Guo, MD, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

June 10, 2021

Study Registration Dates

First Submitted

June 25, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 6, 2021

Study Record Updates

Last Update Posted (Actual)

July 6, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • M2020197

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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