Positive Results Using Variable Fixation in Medial Opening Wedge High Tibial Osteotomies in Patients with Unilateral Knee Osteoarthritis: An Observational Clinical Investigation.

Medial opening wedge high tibial osteotomy (HTO) treats medial knee osteoarthritis by realigning the knee joint, though it still carries quite a high risk of complications. A new Variable Fixation Locking Screw technology, designed to gradually reduce construct stiffness and promote bone healing, aims to address these issues. This observational study evaluates the safety and effectiveness of this innovative approach in improving clinical outcomes. Data were prospectively collected on a cohort of the first ten consecutive patients (over 18 years of age) who underwent corrective medial opening wedge high tibial osteotomy using Variable Fixation Locking Screws (VFLSs). The procedure followed the standard surgical technique, with osteotomies stabilized using a Tomofix plate and a combination of standard locking screws and VFLSs. This study aimed to evaluate outcomes such as fracture healing, patient safety, and procedural success at 6 and 12 weeks and at 6 months. No complications, side effects, or need for implant removal were observed. By six months, 70% of patients showed radiographic and clinical healing, and 100% of patients achieved full functional recovery without any issues like length discrepancy, instability, pain, or joint stiffness. This first clinical observation study indicates that Variable Fixation Locking Screws are safe and effective for medial opening wedge high tibial osteotomies, showing promising results in reducing the risk of delayed closure or non-closure of the wedge. Further studies with a larger patient population are needed to confirm their effectiveness.