An observational study in Anterior Cruciate Ligament Injuries Posterior Cruciate Ligament Tear, sponsored by Medacta International SA. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by Medacta International SA · Observational
An observational prospective study with the aim to assess the clinical outcomes at 1year after surgery for a specific composite IS (Medacta Mectascrew B) 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 toassess the clinical outcomes at 1year after surgery for a specific composite IS (Medacta Mectascrew B) at 12 months following ACL or PCL reconstruction.
Patients with an ACL or PCL tear scheduled for surgery at OCM Klnik GmbH hospital 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-B, Medacta International SA). Data concerning demography, preoperative clinical conditions, surgical details including device implanted, tendon harvesting procedure and complications occurred, postoperative clinical data (as per standard practice at 6 weeks, 6 and/or 12 months) will be prospectively collected, 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 by std x-ray according to standard practice to assess swelling, tunnel widening, and resorption problems. 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
511 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 163 are open to participants now.
This study's planned enrollment of 27 is below the median of 92 across 127 observational studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →Medacta International SA is the lead sponsor of 46 studies on the registry; 18 are open to participants now.
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Patients diagnosed with an ACL or PCL rupture, and meeting the inclusion/ exclusion criteria
Exclusion Criteria:
Device: Mectascrew B
reconstruction of ACL or PCL rupture
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: 12 months
Mobility outcomes evaluation
Assessment throught Range Of Motion of operated knee calculated as degree
Time frame: 6 weeks, 6 months, 12 months
Knee stability evaluation of ACL intervention
Pivot shift test. A positive test indicate an injury at ACL
Time frame: 6 weeks, 6 months, 12 months
ACL integrity assessment
Anterior drawer test. An anterior translation more than 6 mm indicate a positive test with injuried ACL
Time frame: 6 weeks, 6 months, 12 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: 6 weeks, 6 months, 12 months
PCL integrity assessment
Posterior drawer test. The test is considered positive if there is a lack of end feel or excessive posterior translation
Time frame: 6 weeks, 6 months, 12 months
Interference screw integration
Evaluation of ligament osteointegration, femoral/tibial tunnel widening, presence of fluid in the femoral/tibial tunnel by std x-ray
Time frame: 6 weeks, 6 months, 12 months
Incidence of adverse event
collection of adverse event
Time frame: 6 weeks, 6 months, 12 months
Plan to share: No
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Medacta International SA