Functional Follow-up After Endoscopic Calcaneoplasty for Haglund's Deformity

July 9, 2020 updated by: Peking University Third Hospital
Isokinetic muscle strength test implemented by the Biodex system is a method used for evaluating muscle function that has been applied clinically in the field of sports and rehabilitation medicine. However, information on its application on Haglund's deformity remain insufficient. Therefore, the present study is designed to examine the effectiveness of the muscle strength test using the Biodex system in evaluating the recovery of athletic capacity in patients with Haglund's deformity following endoscopic surgery.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital

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

The study included 42 cases of 37 patients diagnosed with Haglund disease treated by the author from 2012 to 2018 treated with endoscopic surgery (5 of whom were patients with left and right feet, 33 men, 4 women, average age 32.3 (range:15 to 62, SD=13.6) years, 2 of whom are professional athletes.

Description

Inclusion Criteria:

  • Patients who underwent endoscopic surgery for Haglund's deformity

Exclusion Criteria:

  • None

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

  • 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
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
Biodex results on both sides at 3 months
Time Frame: 3 months after surgery
Isokinetic strength test conducted on both the injured and uninjured sides of the patients using the Biodex system 3 months after surgery.
3 months after surgery
Biodex results on both sides at 6 months
Time Frame: 6 months after surgery
Isokinetic strength test conducted on both the injured and uninjured sides of the patients using the Biodex system 6 months after surgery.
6 months after surgery

Collaborators and Investigators

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

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 22, 2012

Primary Completion (Actual)

December 22, 2018

Study Completion (Actual)

March 21, 2020

Study Registration Dates

First Submitted

June 27, 2020

First Submitted That Met QC Criteria

July 9, 2020

First Posted (Actual)

July 15, 2020

Study Record Updates

Last Update Posted (Actual)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 9, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

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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