- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04454047
Extracapsular Arthroscopic Treatment for Refractory Tennis Elbow--Mid-and-short Term Retrospective Study of 50 Cases
June 30, 2020 updated by: Peking University Third Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
50
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 Univerisity 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
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The quantitative data of 50 patients (20 men and 30 women) were reviewed.
The minimum age was 35 years, and the maximum age was 55 years old, with an average of 44.6 years.
Description
Inclusion Criteria:
- Diagnosis was refractory tennis elbow;
- Standard extracapsular method was used for surgery.
Exclusion Criteria:
- Patient had past history of joint infection, joint tuberculosis, or osteomyelitis, or the upper limb had undergone surgery within the past 6 months;
- Diagnosis was combined with severe heart, brain, kidney, or another organ dysfunction;
- Case was complicated with other serious elbow joint diseases or injuries;
- Patient did not sign the informed consent form.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Extracapsular method group
50 patients with refractory tennis elbow who received extracapsular arthroscopic surgery.
|
Extracapsular arthroscopy method was used to treat refractory tennis elbow
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mayo Elbow Performance Score
Time Frame: 24 months
|
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
|
Visual Analog Scale
Time Frame: 24 months
|
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
|
Disability of Arm, Shoulder and Hand score
Time Frame: 24 months
|
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
|
Activity of Daily Life recovery time
Time Frame: 24 months
|
Use Activity of Daily Life(ADL) recovery time to evaluate the functional recovery of patients who received extracapsular arthroscopic treatment.
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 20, 2017
Primary Completion (Actual)
November 15, 2017
Study Completion (Actual)
June 26, 2018
Study Registration Dates
First Submitted
June 26, 2020
First Submitted That Met QC Criteria
June 30, 2020
First Posted (Actual)
July 1, 2020
Study Record Updates
Last Update Posted (Actual)
July 1, 2020
Last Update Submitted That Met QC Criteria
June 30, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2017421
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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