- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04471259
Functional Follow-up After Endoscopic Calcaneoplasty for Haglund's Deformity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients. A retrospective (medical records), level 3 evidence study was designed to evaluate the outcomes of patients who underwent endoscopic surgery for Haglund's deformity. The present study was approved by the Peking University Third Hospital's ethics committee. Written informed consent was obtained from all patients, parents or guardians of the patients prior to the present study. The rights of the patients were protected.
Diagnosis. Patients were designed to be diagnosed based on subjective complaints, combined with clinical and radiological examinations. Radiological measurements for this disease include the Fowler-Phillip angle, calcaneal pith angle, parallel pitch lines, Chauveaux-Liet angle and the X/Y ratio.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100191
- Peking University Third Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who underwent endoscopic surgery for Haglund's deformity
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients' injured side
The Biodex, AOFAS, VAS were tested on the patients' injured side
|
We classified patients by gender, age, recovery time,etc
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Patients' uninjured side
The Biodex, AOFAS, VAS were tested on the patients' uninjured side
|
We classified patients by gender, age, recovery time,etc
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biodex results on both sides before surgery
Time Frame: pre-surgery
|
Biodex isokinetic muscle testing system was applied in this research.
Isokinetic muscle strength test is a kind of muscle function evaluation and test method, which has been applied in the research and clinical work of sports medicine and rehabilitation medicine but never on Haglund's disease before.
The isokinetic muscle strength test of the flexor and dorsiflexion of the ankle joint can evaluate the muscle strength and endurance to reflect the postoperative patient's capacity for action, providing reliable clinical evidence for postoperative rehabilitation of patients after endoscopic calcaneoplasties.
Isokinetic strength test conducted on both the injured and uninjured sides of the patients using the Biodex system before surgery.
|
pre-surgery
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Biodex results on both sides at 3 months
Time Frame: 3 months after surgery
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Isokinetic strength test conducted on both the injured and uninjured sides of the patients using the Biodex system 3 months after surgery.
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3 months after surgery
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Biodex results on both sides at 6 months
Time Frame: 6 months after surgery
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Isokinetic strength test conducted on both the injured and uninjured sides of the patients using the Biodex system 6 months after surgery.
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6 months after surgery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2018151
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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