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Recruiting NCT06099600

Anterior Cruciate Ligament Reconstruction

No phase Interventional Ligament Rupture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Reconstructive surgery of the anterior cruciate ligament.
Who it may be relevant to
Registry conditions: Ligament Rupture. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Randomized Study Evaluating the Value of a Pre-habilitation Stay and Digital Follow-up, Compared With Standard Management, in Anterior Cruciate Ligament Reconstruction

Overview

This study evaluates the effectiveness of a pre-habilitation stay via digital monitoring on patients' short-term post-operative anxiety, compared with conventional management.

Detailed description

This is a prospective, comparative, randomized (2-arm), controlled, single-center study of two management modalities.

Recruitment will focus on adult patients with anterior cruciate ligament rupture and scheduled anterior cruciate ligament surgical reconstruction. Patients will be randomized into 2 arms, an experimental arm A (pre-habilitation management) and a control arm B (conventional management).

Interventions

  • Procedure Reconstructive surgery of the anterior cruciate ligament
    surgical reconstruction after rupture of the anterior cruciate ligament is widely proposed as first-line treatment, with the aim of restoring knee joint stability and facilitating functional recovery

Primary outcome measures

  • State-Trait Anxiety Inventory questionnaire [Time frame: 7 days]

Eligibility criteria

Inclusion criteria

  • Age>18;
  • Partial or complete tear of the anterior cruciate ligament;
  • Scheduled anterior cruciate ligament reconstructive surgery;
  • Patient with a tablet, computer or smartphone with an internet connection;
  • Patient able to understand and read French;
  • Willingness to complete questionnaires at regular intervals;
  • Membership of a social security scheme;
  • Signed informed consent.

Exclusion criteria

  • History of anterior cruciate ligament surgery within the past 5 years;
  • Stage III collateral ligament injury;
  • Osteotomy;
  • Neurological (motor and/or sensory), vestibular or rheumatic pathology;
  • Pregnant or breast-feeding woman;
  • Protected adult patient (under guardianship, curatorship or deprivation of liberty).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • Clinique de la Sauvegarde — Lyon

Identifiers

NCT: NCT06099600 · 2023-A01633-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗