Single-stage reconstruction for knees with multiple torn ligaments
Descriptive Study of Multiligamentary Reconstruction of the Knee: Clinical Results and Postoperative Laxity by Dynamic Radiography.
This project will compare allograft versus autograft single-stage knee reconstruction to see which leads to better outcomes and less postoperative looseness in adults with multiple ligament injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Versailles Hospital Academic / other |
| Locations | 1 site (Le Chesnay) |
| Trial ID | NCT03932838 on ClinicalTrials.gov |
What this trial studies
This is a single-center, interventional clinical comparison of adults (>18) who underwent one-time single-stage reconstruction for multiligament knee injuries using either allograft or autograft tissue. Patients receive clinical and radiologic follow-up, including dynamic radiography to measure postoperative laxity in anterior, posterior, varus and valgus planes. The study excludes cases with associated femur or tibia fractures, neurological or vascular trauma, prior surgery on the affected knee, or ligament injury in the opposite knee. Data will be used to describe clinical outcomes and quantify differences in postoperative laxity between the two graft types.
Who should consider this trial
Good fit: Adults over 18 who had a one-time single-stage allograft or autograft reconstruction for multiligament knee injury, with no prior surgery on the affected knee and no associated fractures or neurovascular injuries, are ideal candidates.
Not a fit: Patients with femur or tibia fractures, neurological or vascular injury from the trauma, prior surgery on the affected knee, or ligamentous injury in the contralateral knee are not eligible and would not benefit from participation.
Why it matters
Potential benefit: If successful, the results could help surgeons choose the graft type that reduces postoperative laxity and improves functional outcomes after multiligament knee reconstruction.
How similar studies have performed: There is little published data; one prior study reported postoperative laxity by dynamic radiography but no prior studies directly compare allograft versus autograft in this setting, so the direct comparison is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients operated for one-time allograft or autograft reconstruction of multiligamentous knee injury * \>18 years old Exclusion Criteria: * Neurological or vascular injury during trauma. * Fracture of the femur or both bones of the leg. * Ligamentous lesion on the contralateral knee. * History of surgery on the affected knee.
Where this trial is running
Le Chesnay
- CH de Versailles — Le Chesnay, France (Recruiting)
Study contacts
- Study coordinator: Nicolas Pujol
- Email: npujol@ch-versailles.fr
- Phone: 0139639565
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.