Descriptive Study of Multiligamentary Reconstruction of the Knee

Injury, Knee Clinical Trial

Official title:

Descriptive Study of Multiligamentary Reconstruction of the Knee: Clinical Results and Postoperative Laxity by Dynamic Radiography.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03932838
• Other study ID #: P17/12_ Reconstruction
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: June 1, 2020

Study information

• Verified date: April 2019
• Source: Versailles Hospital
• Contact: Nicolas Pujol
• Phone: 0139639565
• Email: npujol[@]ch-versailles.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of clinical results and postoperative laxity after single-stage reconstruction of multiligamentous lesions of the knee. Comparison of two types of transplant: allograft versus autograft.

There is currently little data in the clinical outcome literature after allograft reconstruction. There is one study reporting postoperative laxity assessed by dynamic radiography in the four planes (anterior, posterior, varus, valgus). No study compares postoperative laxity after allograft versus autograft reconstruction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Injury, Knee
• Knee Injuries

Intervention

Other:
• Clinical and radiologic evaluation
Follow up post surgery: clinical and radiologic evaluation

Locations

Country	Name	City	State
France	CH de Versailles	Le Chesnay

Sponsors (1)

Lead Sponsor	Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Joint mobility of both knees	Postoperative knee function assessed by clinical examination	2 years
Primary	Postoperative laxity in varus, valgus, anterior and posterior drawer	Postoperative knee function assessed by clinical examination	2 years
Primary	Postoperative knee function assessed by scores		2 years