Elbow Arthroscopy SurgeryINPOLANCT07661615
Arthroscopic or Open Evaluation of Posterolateral Instability Associated With Lateral Epicondylitis
An observational study of Elbow Arthroscopy Surgery and Elbow Injury, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elbow Arthroscopy Surgery, Elbow Injury, Epicondylitis of the Elbow
- What is being tested?
- elbow surgery and Questionnaire Quickdash
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Feb 2022to 25 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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. ...
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Privé Jean Mermoz
Lyon, 69008
Institut chirurgical de la Main et du Membre Supérieur
Villeurbanne, 69100
About this study
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.
Read more
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.
- Conditions
- Elbow Arthroscopy Surgery, Elbow Injury, Epicondylitis of the Elbow, Epicondylitis, Lateral
- Being tested
- elbow surgery, Questionnaire Quickdash
- Medical subject headings
- Elbow Injuries, Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elbow surgeryProcedure or surgery
Elbow surgery : arthroscopic or open.
Questionnaire QuickdashOther
Difference in QuickDash scores between the preoperative and postoperative visit; score from 0 to 100 (0, no disability to 100, most severe disability).
| Study group | Role | What they receive |
|---|---|---|
| Patient scheduled for elective elbow surgery, either arthroscopic or open. | Not described Receives: Procedure: elbow surgery; Other: Questionnaire Quickdash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start2 Feb 2022
- Primary completion20 Jun 2024
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow Arthroscopy SurgeryStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661615
- Sponsor's protocol ID
- 2020-A01931-38
- Acronym
- INPOLA
- Status last verified
- Jul 2026
- First submitted
- 16 Jun 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic or Open Evaluation of Posterolateral Instability Associated With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT07661615
- Acronym / sponsor ID
- INPOLA / 2020-A01931-38
- Conditions
- Elbow Arthroscopy Surgery, Elbow Injury, Epicondylitis of the Elbow, Epicondylitis, Lateral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient scheduled for elective elbow surgery, either arthroscopic or open. | – | Procedure: elbow surgery, Other: Questionnaire Quickdash |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elbow surgeryElbow surgery : arthroscopic or open. | Procedure or surgery | Patient scheduled for elective elbow surgery, either arthroscopic or open. |
| Questionnaire QuickdashDifference in QuickDash scores between the preoperative and postoperative visit; score from 0 to 100 (0, no disability to 100, most severe disability). | Other | Patient scheduled for elective elbow surgery, either arthroscopic or open. |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elbow Arthroscopy Surgery and Elbow Injury, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with posterolateral elbow instability. (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.