Arthroscopic or Open Evaluation of Posterolateral Instability Associated With Lateral Epicondylitis (INPOLA)

The elbow is a complex joint made up of three bones, three joints, and three ligaments. Repeated microtraumas can lead to ligament injuries and instability, tendon damage, or degenerative processes affecting the bones, cartilage, and bursae. As a result, elbow pain is not uncommon, and diagnosing the underlying problem is not always easy. One reason for this is the complex anatomy packed into a small space. Many disorders produce overlapping symptoms, making them hard to tell apart. In this context, diagnostic confusion isn't unusual. So, posterolateral rotatory instability of the elbow has symptoms similar to those of lateral epicondylitis, the main diagnosis for a painful elbow, but the way it's treated is different.

However, a wrong diagnosis can be linked to treatment failure risks that might put the patient in a therapeutic, social, or work/sports dead end. An accurate and early diagnosis could allow for quickly setting up a treatment strategy suited to the condition.

The relationship between posterolateral elbow instability and lateral epicondylitis has been little studied in the literature. This project is based on the hypothesis that lateral epicondylitis is often associated with posterolateral instability. Checking the lateral collateral ligament of the elbow during scheduled surgery to treat lateral epicondylitis, either arthroscopically or openly, could help better assess this relationship.

The main aim of this study is to figure out the percentage of patients with posterolateral elbow instability, diagnosed either through arthroscopy or open surgery, among those with lateral epicondylitis who are up for surgery.

Study Overview

Study Type

Observational

Enrollment (Actual)

30

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

      • Lyon, France, 69008
        • Hôpital privé Jean Mermoz
      • Villeurbanne, France, 69100
        • Institut chirurgical de la Main et du Membre Supérieur

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with lateral epicondylitis of the elbow who require surgical treatment are referred to the orthopedics departments of Jean Mermoz Private Hospital and the Surgical Institute of the Hand and Upper Limb - ICMMS. Patients scheduled for this type of surgery and who meet the eligibility criteria will be offered the opportunity to participate in the study by the orthopedic surgeon during the pre-operative consultation. If inclusion hasn't taken place during the pre-op consultation, it can happen the day before the surgery.

Description

Inclusion Criteria:

  • Patient, male or female, over 18 years old.
  • Patient who has had pain in the lateral compartment of the elbow and has received well-managed medical treatment (splint, injection) for at least 6 months.
  • Patient scheduled for planned elbow surgery, either arthroscopic or open.
  • Patient with tenderness in the lateral epicondyle area.
  • Patient experiencing pain at the lateral epicondyle during resisted wrist extension.
  • Patient enrolled in or receiving benefits from a social security program.
  • Patient has been informed and does not object to this research. ...

Exclusion Criteria:

  • Patient with a history of elbow surgery, dislocation, or fracture.
  • Patient with elbow deformities.
  • Patient with synovial plica.
  • Protected patient: adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision.
  • Pregnant, breastfeeding, or laboring woman.
  • Patient hospitalized without consent.

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
Patient scheduled for elective elbow surgery, either arthroscopic or open.
Elbow surgery : arthroscopic or open.
Difference in QuickDash scores between the preoperative and postoperative visit; score from 0 to 100 (0, no disability to 100, most severe disability).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with posterolateral elbow instability.
Time Frame: one day
This instability is diagnosed during scheduled surgery, either arthroscopically or with an open procedure, by the presence of a lateral collateral ligament injury.
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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)

February 2, 2022

Primary Completion (Actual)

June 20, 2024

Study Completion (Actual)

November 25, 2025

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

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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