An observational prospective study with the aim to analyze the presence at 6 months of a specific composite IS (Medacta Mectascrew C) in the reconstructive treatment of ruptured ACL or PCL by means of an autograft or allograft.
This is an observational prospective study with the aim to determine the presence of the composite IS (Mectascrew-C) at 6 months following ACL or PCL reconstruction. Patients with an ACL or PCL tear scheduled for surgery at one of the EOC's hospitals will be enrolled in the study, after the subscription of informed consent. The injured ligament will be restored with an auto- or allograft that will be fixed with a composite IS (Mectascrew-C, 70% PLDLLA, 30% β-TCP, Medacta International SA). The data will be collected from patient's medical histories (data about diagnosis, patients' characteristics and surgery) and after operation, during the orthopaedic follow-up visits, planned at 1, 3 and 6 months, in order to assess the functional outcomes (IKDC objective and subjective) and the knee stability (ROM, Pivot Shift or Reverse Pivot Shift test, anterior or posterior drawer test) of the patients. The treated knee will be also evaluated radiologically with an MRI at 6 months to assess the IS reabsorption. The results of this exam will be correlated to the pre-operative findings and to the functional and clinical outcomes evaluated with the different forms
Study Type
OBSERVATIONAL
Enrollment
44
reconstruction of ACL or PCL rupture
EOC, Service of Orthopaedics and Traumatology
Lugano, Switzerland
RECRUITINGInterference screw presence
via MRI imaging at 6 months after surgery, the presence of the Mectascrew-C will be assessed
Time frame: 6 months
Mobility outcomes evaluation
Assessment throught Range Of Motion of operated knee calculated as degree
Time frame: 1, 3 and 6 months
Functional outcomes evaluation
Assessment throught IKCD score. a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Time frame: 1, 3 and 6 months
Knee stability evaluation of ACL intervention
Pivot shift test. A positive test indicate an injury at ACL
Time frame: 1, 3 and 6 months
ACL integrity assessment
Anterior drawer test. An anterior translation more than 6 mm indicate a positive test with injuried ACL
Time frame: 1, 3 and 6 months
Knee stability evaluation of PCL intervention
Reverse Pivot Shift test. In the presence of a posterolateral injury with the knee flexed, the tibia follows gravity and drops into posterolateral subluxation (positive Reverse Pivot Shift Test).
Time frame: 1, 3 and 6 months
PCL integrity assessment
Posterior drawer test. The test is considered positive if there is a lack of end feel or excessive posterior translation.
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Time frame: 1, 3 and 6 months
Device safety evaluation
collection of adverse event
Time frame: 1, 3 and 6 months