MedDataX Logo

Assessment of Surgical Correction of Patello-femoral Instability by EOS 3D Kinematics

NCT ID: NCT04143438

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-02

Study Completion Date

2022-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Assessment of surgical correction of patello-femoral instability by EOS 3D kinematics

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patella instability induces repetitive patella dislocation, which impairs day-to-day life. Surgery is commonly used to stabilise the patella during knee flexion. However proofs of efficacy of surgery on patello-femoral kinematics have not yet been found. Analysis of the patello-femoral kinematics is crucial to understand, assess et correct the patella instability. The investigators have developed, validated and published a 3D analysis method from biplanar X-rays (EOS 3D imaging). Our aim in this study is to assess the correction of the patello-femoral kinematics after surgery using the EOS 3D imaging method.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patellofemoral Dislocation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

patella EOS 3D imaging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Undergoing EOS 3D imaging

Patients with patello-femoral instability will undergo EOS 3D Imaging protocol before and after undergoing corrective surgery

Group Type EXPERIMENTAL

EOS 3D imaging protocol pre- and post-surgery

Intervention Type PROCEDURE

Patients will undergo a EOS 3D Imaging protocol before and 6 months after undergoing patello-femoral surgery. This protocol is already used routinely in the hospital before every patello-femoral surgery.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EOS 3D imaging protocol pre- and post-surgery

Patients will undergo a EOS 3D Imaging protocol before and 6 months after undergoing patello-femoral surgery. This protocol is already used routinely in the hospital before every patello-femoral surgery.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age above 15 years and 3 months (minimal age to be allowed for adult orthopedic surgery in the hospital)
* Patients with patello-femoral instability (at least one patella dislocation)
* Patients with corrective surgery planned
* Patients must be covered by public health insurance
* Signed informed consent form by the patient or by the parents or legal guardian of the patient (if patient is under 18)

Exclusion Criteria

* Previous existing surgery for patella instability on the same knee
* Previous existing surgery on the extensor apparatus of the knee
* Female patients with pregnancy
* Patients deprived of liberty by administrative or court order
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Louis DAGNEAUX

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UH Montpellier

Montpellier, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Dagneaux L, Thoreux P, Eustache B, Canovas F, Skalli W. Sequential 3D analysis of patellofemoral kinematics from biplanar x-rays: In vitro validation protocol. Orthop Traumatol Surg Res. 2015 Nov;101(7):811-8. doi: 10.1016/j.otsr.2015.07.017. Epub 2015 Oct 26.

Reference Type BACKGROUND
PMID: 26514850 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UF 9892

Identifier Type: OTHER

Identifier Source: secondary_id

RECHMPL17_0383

Identifier Type: -

Identifier Source: org_study_id