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Completed

NCT Number: NCT04454060

Study on the Development of Arthroscopic Treatment of Refractory Tennis Elbow

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Univerisity Third Hospital

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extracapsular arthroscopy

Procedure

Extracapsular arthroscopy method was used to treat refractory tennis elbow

Primary outcomes

  1. Mayo Elbow Performance Score

    Time frame: 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.

  2. Visual Analog Scale

    Time frame: 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.

  3. Disability of Arm, Shoulder and Hand score

    Time frame: 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.

  4. Activity of Daily Life recovery time

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jul 1, 2020
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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