Study on the Development of Arthroscopic Treatment of Refractory Tennis Elbow

Tennis Elbow Clinical Trial

Official title:

Study on the Development of Arthroscopic Treatment of Refractory Tennis Elbow

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04454060
• Other study ID #: M2018063
• Status: Completed
• Start date: May 23, 2018
• Est. completion date: May 2, 2019

Study information

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

Clinical Trial Summary

The aim of this study was to investigate the exploration history, key theories, methods, and techniques involved in the evolution from the intracapsular method to the extracapsular method for arthroscopic treatment of tennis elbow, and explore the effectiveness and safety of extracapsular method on the basis of retrospective analysis of 43 cases.

Description:

Background: Arthroscopic surgery is widely used in the treatment of refractory tennis elbow due to its advantages of minimally invasive, safe and direct vision. Intra-capsular arthroscopy(intracapsular method), which is performed via natural cavity, is the mainstream arthroscopic procedure. However, intracapsular method requires the damage of joint capsule and may cause intraoperative neurovascular injury and other complications. In view of the defects of intracapsular method, the surgical scheme of the extracapsular arthroscopy (referred to as "extracapsular method") has emerged. The aim of this study was to investigate the exploration history, key theories, methods, and techniques involved in the evolution from the intracapsular method to the extracapsular method for arthroscopic treatment of tennis elbow, and explore the effectiveness and safety of extracapsular method.

Methods: Qualitative data were collected via focus group interview. 7 surgeons who were selected through purposive sampling discussed on the theories, methods, and technical specifications of the transition from intracapsular method to extracapsular method. Qualitative data were analysed using NVivo11. Quantitative data of consecutive 43 patients were analysed to evaluate the effectiveness and safety of the extracapsular method. Descriptive analysis was conducted to analyse the demographic characteristics and clinical outcomes after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2, 2019
• Est. primary completion date: November 23, 2018
• Accepts healthy volunteers: No
• 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.

Related Conditions & MeSH terms

• Tennis Elbow

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.	12 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.	12 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.	12 months
Primary	Activity of Daily Life recovery time	Use Activity of Daily Life recovery time to evaluate the functional recovery of patients who received extracapsular arthroscopic treatment.	12 months