- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04950361
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
Conditions
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.
Sponsor
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.
Clinical Trials on Talocalcaneal Coalition
-
University Hospital, LimogesNot yet recruitingCalcaneonavicular CoalitionFrance
-
Ain Shams UniversityCompletedPes Planus | Talocalcaneal BarEgypt
-
Odense University HospitalOdense Patient Data Explorative NetworkRecruitingToe Joint Deformity | Clubfoot | Flatfoot | Trigger Finger | Syndactyly | Hand Deformities, Congenital | Tarsal Coalition | Congenital Talipes Equinovarus | Valgus Foot Deformity | Club Foot | Polydactyly Toe | Thumb Hypoplasia | Polydactyly; Fingers | Osteomyelitis of Hindfoot | Osteomyelitis of Midfoot | Congenital Talipes... and other conditionsDenmark
Clinical Trials on talocalcaneal coalition
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalRecruiting
-
MedShape, IncMedical University of South CarolinaNot yet recruitingFoot ArthritisUnited States
-
The University of Texas Health Science Center,...National Institute on Drug Abuse (NIDA); Penn State UniversityEnrolling by invitationSubstance Use | Adolescent Problem BehaviorUnited States
-
MedShape, IncUniversity of California, DavisRecruitingFoot ArthritisUnited States
-
University of Texas Southwestern Medical CenterEmory UniversityTerminatedDystonia
-
Ain Shams UniversityCompletedPes Planus | Talocalcaneal BarEgypt
-
MaineHealthCompletedPneumonia | Asthma | Tobacco Cessation | Tobacco Smoking | Bronchiolitis | Bronchopulmonary Dysplasia | Reactive Airway DiseaseUnited States
-
Aalborg UniversityWithdrawn
-
University of California, San FranciscoNational Institute of Allergy and Infectious Diseases (NIAID); San Francisco... and other collaboratorsRecruiting