Osteoarthritis (OA) represents a leading cause of disability and a growing burden on healthcare budgets. OA is particularly vexing for young, active patients who have failed less invasive therapies but are not yet candidates for arthroplasty. Often, patients suffering in this wide therapeutic gap face a debilitating spiral of disease progression, increasing pain, and decreasing activity until they become suitable arthroplasty patients. An implantable load absorber was evaluated for the treatment of medial knee OA in this patient population. Joint overload has been cited as a contributor to OA onset or progression. In response, the KineSpring® System (Moximed, Inc, USA) has been designed to reduce the load acting on the knee. The absorber is implanted in the subcutaneous tissue without violating the joint capsule, thus preserving the option of future arthroplasty. The implant is particularly useful for young, active patients, given the reversibility of the procedure and the preservation of normal flexibility and range of motion. The KineSpring System was implanted in 55 patients, with the longest duration exceeding two years. The treated group had medial knee OA, included younger OA sufferers (range 31–68 years), with a mean BMI > 30kg/m2. Acute implant success, adverse events, and clinical outcomes using validated patient reported outcomes tools were recorded at baseline, post-op, 2 and 6 weeks, and 3, 6, 12 and 24 months post-op. All patients were successfully implanted with a mean procedure time of 76.4 min (range 54–153 minutes). Mean hospital length of stay was 1.7 days (range 1–3 days), and patients recovered rapidly, achieving full weight bearing within 1–2 wks and normal range of motion by 6 weeks. Most patients experienced pain relief and functional improvement with 85% (35/41) reporting none or mild pain on the WOMAC pain subscale and 90% (37/41) reporting functional impairment as none on mild on the WOMAC function subscale at the latest follow-up visit (mean 9.3 ± 3.5 months). Clinically meaningful and statistically significant pain reduction and functional improvement were noted with baseline WOMAC pain scores (0–100 scale) improving from 42.4 to 16.1 (p<0.001) and WOMAC function (0–100 scale) improving from 42.0 to 14.7 (p<0.001) at latest follow-up. Patients reported satisfaction with the implant and its appearance.Introduction
Methods and Results
The UK and Australian clinical experience of an implantable load absorber was reviewed for knee OA patients who have exhausted conservative care, but are not ideal candidates for HTO or arthroplasty due to age, activity level, obesity, or disinclination. The load absorber was implanted in 58 patients, with the longest duration exceeding two years. Patients included younger OA sufferers (31-68 years), and had a mean BMI > 30kg/m2. Early surgical experience and adverse events with the device were recorded and clinical outcomes using validated patient reported outcomes tools were collected at baseline, post-op, 2 and 6 weeks, and 3, 6, 12 and 24 month timepoints. All patients were successfully implanted with a mean surgical time of 76.4 minutes (range 54-153). After a mean hospital stay of 1.7 days (range 1-3), patients resumed full weight bearing within 1-2 weeks and achieved normal range of motion by 6 weeks. Mean WOMAC pain (0-100 scale) improved from 42.4 to 16.1 (p<0.001); mean WOMAC function (0-100 scale) improved from 42.0 to 14.7 (p<0.001). Most patients reported “no or mild” pain (85%) or “no or mild” functional impairment (90%) at last follow-up (9.5 ± 3.5 months). Patients reported high satisfaction with the implant. Initial UK results mirror the positive Australian experience: reduced pain, improved function, and high satisfaction. Complications arising in the early surgical experience were effectively resolved through revised surgical technique and minor design modifications.Statement of Purpose
Methods and Results