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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04454047
Other study ID # M2017421
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 20, 2017
Est. completion date June 26, 2018

Study information

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

Clinical Trial Summary

This study retrospectively analysed surgical outcomes of consecutive 50 cases to investigate the technical standard and clinical effect of extracapsular arthroscopic treatment for refractory tennis elbow.


Description:

To investigate the technical standard of extracapsular arthroscopic treatment for refractory tennis elbow. Consecutive 50 cases of refractory tennis elbow from 50 patients who underwent extracapsular arthroscopic surgery which performed independently by the same doctor from March 2012 to November 2016 was retrospectively analyzed. The key points of technical standard were summarized, including debridement, decortication and microfracture, suture under arthroscopy and postoperative cast fixation. Visual Analogue Scale(VAS), Mayo elbow performance score and Disability of Arm, Shoulder, and Hand outcome measure (DASH) were evaluated for postoperative results. The effects of various technical points were analyzed by rank sum test, independent sample t test, χ2 test and multiple logistic regression.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date June 26, 2018
Est. primary completion date November 15, 2017
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

1. Diagnosis was refractory tennis elbow;

2. Standard extracapsular method was used for surgery.

Exclusion Criteria:

1. Patient had past history of joint infection, joint tuberculosis, or osteomyelitis, or the upper limb had undergone surgery within the past 6 months;

2. Diagnosis was combined with severe heart, brain, kidney, or another organ dysfunction;

3. Case was complicated with other serious elbow joint diseases or injuries;

4. Patient did not sign the informed consent form.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Extracapsular arthroscopy
Extracapsular arthroscopy method was used to treat refractory tennis elbow

Locations

Country Name City State
China Peking Univerisity 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 Mayo Elbow Performance Score Use Mayo Elbow Performance Score(MEPS) to evaluate the functional recovery of patients who received extracapsular arthroscopic treatment. MEPS ranges from 0 to 100, higher scores mean a better outcome. 24 months
Primary Visual Analog Scale Use Visual Analog Scale(VAS) to evaluate the pain recovery of patients who received extracapsular arthroscopic treatment. VAS ranges from 0 to 10, higher scores mean a worse outcome. 24 months
Primary Disability of Arm, Shoulder and Hand score Use Disability of Arm, Shoulder and Hand(DASH) score to evaluate the functional and pain recovery of patients who received extracapsular arthroscopic treatment. DASH ranges from 0 to 100, higher scores mean a worse outcome. 24 months
Primary Activity of Daily Life recovery time Use Activity of Daily Life(ADL) recovery time to evaluate the functional recovery of patients who received extracapsular arthroscopic treatment. 24 months
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