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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04471259
Other study ID # M2018151
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 22, 2012
Est. completion date March 21, 2020

Study information

Verified date July 2020
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date March 21, 2020
Est. primary completion date December 22, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients who underwent endoscopic surgery for Haglund's deformity

Exclusion Criteria:

- None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Classification statistics
We classified patients by gender, age, recovery time,etc

Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biodex results on both sides before 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
Primary Biodex results on both sides at 3 months 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
Primary Biodex results on both sides at 6 months 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