Identifying patients needing ACL reconstruction after rehabilitation
Rate of Non-copers to Non-surgical ACL Treatment After 3 Months of Rehabilitation - a Prospective Cohort Study
This study is testing a new screening tool to see if it can help identify patients who might need surgery after three months of rehab for an ACL injury.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 357 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | All |
| Sponsor | Vejle Hospital Academic / other |
| Locations | 1 site (Vejle, Region Syddanmark) |
| Trial ID | NCT04847258 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of a screening tool designed to identify patients who are likely to require ACL reconstruction after undergoing three months of standard rehabilitation for an anterior cruciate ligament injury. Patients with unilateral primary ACL injuries will be screened at baseline and again after three months of rehabilitation by a physiotherapist. The study focuses on assessing the sensitivity and specificity of the screening tool to determine which patients are classified as non-copers, indicating a need for surgical intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with a unilateral primary ACL injury that occurred within the last six months.
Not a fit: Patients with multiligament ruptures or significant cartilage or meniscus injuries, as well as those scheduled for ACL reconstruction within three months, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients who may benefit from earlier surgical intervention, potentially improving recovery outcomes.
How similar studies have performed: While similar studies have explored rehabilitation outcomes for ACL injuries, the specific use of this screening tool for identifying non-copers is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * unilateral primary ACL injury * Index injury no older than 6 months Exclusion Criteria: * Multiligament rupture * Large cartillage or meniscus injuries * Scheduled ACL reconstruction within 3 months
Where this trial is running
Vejle, Region Syddanmark
- Vejle Hospital — Vejle, Region Syddanmark, Denmark (Recruiting)
Study contacts
- Study coordinator: Kamilla Arp, MSc
- Email: kamilla.dessau.arp@rsyd.dk
- Phone: +45 79406796
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.