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OpenTrials
Completed

NCT Number: NCT07661615

Arthroscopic or Open Evaluation of Posterolateral Instability Associated With Lateral Epicondylitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Privé Jean Mermoz, Lyon, France

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

elbow surgery

Procedure

Elbow surgery : arthroscopic or open.

Questionnaire Quickdash

Other

Difference in QuickDash scores between the preoperative and postoperative visit; score from 0 to 100 (0, no disability to 100, most severe disability).

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: INPOLA

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jun 22, 2026
Registry last updated
Jul 16, 2026

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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