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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04955535
Other study ID # M201947901
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 3, 2020
Est. completion date December 27, 2020

Study information

Verified date June 2021
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study retrospectively analyzed the history of present illness of PVNS patients in our hospital. The enrolled patients were followed up by telephone to follow up their postoperative recovery and living conditions. Take the patient's pathological specimens for immunohistochemical testing, evaluate the relationship between the expression of different molecular targets, clinical manifestations and patient prognosis, and explore new molecular targets related to disease diagnosis and treatment.


Description:

This study retrospectively analyzed the symptoms, time of onset, injury history, laboratory examinations, imaging examinations, and intraoperative conditions of PVNS patients in our hospital. The enrolled patients were followed up by telephone to follow up their postoperative recovery and living conditions (VAS score, SF-36 score). Take the patient's pathological specimens for immunohistochemical testing, evaluate the relationship between the expression of different molecular targets, clinical manifestations and patient prognosis, and explore new molecular targets related to disease diagnosis and treatment.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 27, 2020
Est. primary completion date December 27, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: 1. Clinical diagnosis of pigmented villonodular synovitis. 2. Clinical diagnosis of giant cell tumor of tendon sheath Exclusion Criteria: 1. No surgical treatment. 2. There were no pathological specimens during the operation. 3. The age of the patient is less than 18 years old or more than 60 years old. 4. The operation record shows nodular type.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Arthroscopic synovectomy
Arthroscopic synovectomy

Locations

Country Name City State
China Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries, Beijing, China 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 Difference of scale score between immunohistochemistry positive group and negative group Difference of Visual Analog Score for pain between CSF-1 immunohistochemistry positive group and negative group One week after surgery
Primary Difference of Visual Analog Score for pain between TNF-a immunohistochemistry positive group and negative group Difference of Visual Analog Score for pain between TNF-a immunohistochemistry positive group and negative group One week after surgery
Primary Difference of Visual Analog Score for pain between IL-1B immunohistochemistry positive group and negative group Difference of Visual Analog Score for pain between IL-1B immunohistochemistry positive group and negative group One week after surgery
Primary Difference of SF-36 score between CSF-1 immunohistochemistry positive group and negative group Difference of SF-36 score between CSF-1 immunohistochemistry positive group and negative group One week after surgery
Primary Difference of SF-36 score between TNF-a immunohistochemistry positive group and negative group Difference of SF-36 score between TNF-a immunohistochemistry positive group and negative group One week after surgery
Primary Difference of SF-36 score between IL-1B immunohistochemistry positive group and negative group Difference of SF-36 score between IL-1B immunohistochemistry positive group and negative group One week after surgery
Secondary Correlation between basic demographic characteristics and scale scores Correlation between age, gender and scale score One week after surgery
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