Study on the Development of Arthroscopic Treatment of Refractory Tennis Elbow

Sponsor

Peking University Third Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04454060

Collaborator

(none)

Enrollment

Location

11.3

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Tennis Elbow	Procedure: Extracapsular arthroscopy

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

43 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Study on the Development of Arthroscopic Treatment of Refractory Tennis Elbow

Actual Study Start Date :

May 23, 2018

Actual Primary Completion Date :

Nov 23, 2018

Actual Study Completion Date :

May 2, 2019

Arms and Interventions

Arm	Intervention/Treatment
Extracapsular method group consecutive 43 patients who received extracapsular method treatment for refractory tennis elbow	Procedure: Extracapsular arthroscopy Extracapsular arthroscopy method was used to treat refractory tennis elbow

Arm

Intervention/Treatment

Extracapsular method group

consecutive 43 patients who received extracapsular method treatment for refractory tennis elbow

Procedure: Extracapsular arthroscopy

Extracapsular arthroscopy method was used to treat refractory tennis elbow

Outcome Measures

Primary Outcome Measures

Mayo Elbow Performance Score [12 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.
Visual Analog Scale [12 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.
Disability of Arm, Shoulder and Hand score [12 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.
Activity of Daily Life recovery time [12 months]
Use Activity of Daily Life recovery time to evaluate the functional recovery of patients who received extracapsular arthroscopic treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.