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Recruiting

NCT Number: NCT06099600

Anterior Cruciate Ligament Reconstruction

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

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique de la Sauvegarde

Lyon, 69009, France

Location status: Recruiting

Location contact

David DEJOUR, MD

CONTACT

[email protected]

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Reconstructive surgery of the anterior cruciate ligament

Procedure

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 outcomes

  1. State-Trait Anxiety Inventory questionnaire

    Time frame: 7 days

    The main evaluation criterion is the total "state-anxiety" score of the State-Trait Anxiety Inventory questionnaire on 7 days compared to the score measured at least 25 days (i.e. baseline value: before the surgical intervention and before the pre-habilitation stay taking place for patients in the experimental group)

Study contacts

Contact information is provided by the study sponsor or research team.

David DEJOUR, MD

CONTACT

[email protected]

472200000 ext. +33

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • Euraxi Pharma

Registry information

Official study title

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

Acronym: Préhab-LCA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 25, 2023
Registry last updated
Jul 28, 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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