Digital pre-habilitation before anterior cruciate ligament reconstruction
Randomized Study Evaluating the Value of a Pre-habilitation Stay and Digital Follow-up, Compared With Standard Management, in Anterior Cruciate Ligament Reconstruction
This project will test whether a digital pre-habilitation program and remote monitoring can reduce short-term post-operative anxiety for adults undergoing ACL reconstruction compared with usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT06099600 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, two-arm, single-center comparison of digital pre-habilitation versus conventional management for patients scheduled for anterior cruciate ligament reconstruction. Adult patients with primary partial or complete ACL rupture who can read French and use an internet-connected device will be randomized to either a monitored digital pre-habilitation pathway or standard care. The primary focus is short-term post-operative anxiety, measured with regular questionnaires delivered before and after surgery. The intervention combines remote education, exercise guidance, and digital monitoring ahead of the reconstructive procedure.
Who should consider this trial
Good fit: Adults over 18 with a primary partial or complete ACL rupture who are scheduled for reconstructive surgery, can read French, have an internet-capable device, and can give informed consent are ideal candidates.
Not a fit: Patients with recurrent or contralateral lesions, stage III collateral ligament injuries, planned osteotomy, significant neurological/vestibular/rheumatic conditions, pregnant or breastfeeding women, those under legal protection, or those without a suitable internet device or French language ability are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could reduce short-term anxiety around surgery and improve patients' preparedness for ACL reconstruction.
How similar studies have performed: Some prehabilitation and digital-monitoring programs in orthopedics have shown reductions in anxiety and improved perioperative outcomes, but this exact digital pre-habilitation approach for ACL reconstruction is not yet well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 ; * Partial or complete primary anterior cruciate ligament rupture; * Partial or complete primary rupture 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: * Recurrence / contralateral lesion ; * 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).
Where this trial is running
Lyon
- Clinique de la Sauvegarde — Lyon, France (Recruiting)
Study contacts
- Study coordinator: David DEJOUR, MD
- Email: dejour.secretariat@lyon-ortho-clinic.com
- Phone: 472200000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.