NCT07661615

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

February 2, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

2.4 years

First QC Date

June 16, 2026

Last Update Submit

July 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with posterolateral elbow instability.

    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

Study Arms (1)

Patient scheduled for elective elbow surgery, either arthroscopic or open.

Procedure: elbow surgeryOther: Questionnaire Quickdash

Interventions

elbow surgeryPROCEDURE

Elbow surgery : arthroscopic or open.

Patient scheduled for elective elbow surgery, either 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).

Patient scheduled for elective elbow surgery, either arthroscopic or open.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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. ...

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Location

Institut chirurgical de la Main et du Membre Supérieur

Villeurbanne, 69100, France

Location

MeSH Terms

Conditions

Elbow InjuriesTennis Elbow

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and InjuriesElbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesTendon Injuries

Study Design

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

Study Record Dates

First Submitted

June 16, 2026

First Posted

June 22, 2026

Study Start

February 2, 2022

Primary Completion

June 20, 2024

Study Completion

November 25, 2025

Last Updated

July 16, 2026

Record last verified: 2026-07

Locations