NCT04454047

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

6 months

First QC Date

June 26, 2020

Last Update Submit

June 30, 2020

Conditions

Keywords

Refractory tennis elbowArthroscopyIntracapsular methodExtracapsular methodSurgical technology

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Extracapsular method group

50 patients with refractory tennis elbow who received extracapsular arthroscopic surgery.

Procedure: Extracapsular arthroscopy

Interventions

Extracapsular arthroscopy method was used to treat refractory tennis elbow

Extracapsular method group

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Diagnosis was refractory tennis elbow;
  • Standard extracapsular method was used for surgery.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Univerisity Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2020

First Posted

July 1, 2020

Study Start

May 20, 2017

Primary Completion

November 15, 2017

Study Completion

June 26, 2018

Last Updated

July 1, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations