Evaluating knee laxity during ACL and meniscus surgeries
Intraoperative Laxity Evaluation of Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Revision and Meniscus Transplantation
Istituto Ortopedico Rizzoli · NCT03441165
This study tests how loose the knee is in people having surgery for ACL injuries or meniscus problems to see how well the surgeries work.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 14 Years to 65 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli (other) |
| Locations | 1 site (Bologna, Italia) |
| Trial ID | NCT03441165 on ClinicalTrials.gov |
What this trial studies
This study evaluates knee laxity in patients undergoing anterior cruciate ligament (ACL) reconstruction, ACL revision, or meniscus transplantation. Participants will have their knee's kinematic data assessed both before and after the surgical procedure using advanced systems. The study focuses on comparing the static and dynamic laxity of the knee joint to determine the effectiveness of the surgical interventions. All necessary data will be collected during the operation, eliminating the need for follow-up assessments.
Who should consider this trial
Good fit: Ideal candidates are patients aged 14 to 65 who are scheduled for ACL reconstruction, ACL revision, or meniscus transplantation.
Not a fit: Patients who are unable to understand the study or have not provided informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical techniques and improve outcomes for patients undergoing ACL and meniscus surgeries.
How similar studies have performed: While there have been studies on knee laxity, this specific approach using intraoperative kinematic evaluation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who have provided written informed written consent 2. Patients aged 14 to 65 3. Patients undergoing reconstructive surgery of the anterior cruciate ligament or revision of anterior cruciate ligament surgery or meniscus transplantation. Patients unable to understand and want patients who have not signed informed consent Exclusion Criteria: 1. Patients unable to understand and to want 2. Patients who have not signed informed consent
Where this trial is running
Bologna, Italia
- Stefano Zaffagnini — Bologna, Italia, Italy (RECRUITING)
Study contacts
- Principal investigator: Stefano Zaffagnini — stefano.zaffagnini@unibo.it
- Study coordinator: Stefano Zaffagnini
- Email: stefano.zaffagnini@unibo.it
- Phone: 051 6366075
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.
Conditions: Intraoperative Musculoskeletal Injury, ACL, MAT, REVISION, LAXITY