The objective of this clinical study was to test if blood from osteoarthritis (OA) patients (n = 105) could be processed by a device system to form an autologous protein solution (APS) with preferentially increased concentrations of anti-inflammatory cytokines compared to inflammatory cytokines. To address this objective, APS was prepared from patients exhibiting radiographic evidence of knee OA. Patient metrics were collected including: demographic information, medical history, medication records, and Knee Injury and Osteoarthritis Outcome Score (KOOS) surveys. Cytokine and growth factor concentrations in whole blood and APS were measured using enzyme-linked immunosorbent assays. Statistical analyses were used to identify relationships between OA patient metrics and cytokines. The results of this study indicated that anti-inflammatory cytokines were preferentially increased compared to inflammatory cytokines in APS from 98% of OA patients. APS contained high concentrations of anti-inflammatory proteins including 39,000 ± 20,000 pg/ml IL-1ra, 21,000 ± 5,000 pg/ml sIL-1RII, 2,100 ± 570 pg/ml sTNF-RI, and 4,200 ± 1,500 pg/ml sTNF-RII. Analysis of the 82 patient metrics indicated that no single patient metric was strongly correlated (R2 > .7) with the key cytokine concentrations in APS. Therefore, APS can be prepared from a broad range of OA patients.

Osteoarthritis (OA) is a progressive and degenerative disease, which may result in significant pain and decreased quality of life. Recent updates in our understanding of OA have demonstrated that it is a whole joint disease that has many similarities to an unhealed wound containing inflammatory cytokines. The nSTRIDE Autologous Protein Solution (APS) Kit is a medical device under development for the treatment of OA. The APS Kit processes a patient's own blood at the point of care to contain high concentrations of anti-inflammatory cytokines and anabolic growth factors. This study assessed the safety and treatment effects of a single intra-articular injection of APS. Eleven patients were enrolled in this study. Sufficient blood could not be drawn from one patient who was subsequently withdrawn, leaving 10 patients treated. Minor adverse events (AEs) were experienced by seven subjects (63.6%). There was one serious AE (diverticulitis) unrelated to the device or procedure. One subject experienced AEs that were judged “likely” to be procedure related (arthralgia/musculoskeletal discomfort) and all resolved within 6 days of injection. All other AEs were unrelated to the device or procedure. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scores improved significantly over time (ANOVA, p < 0.0001, 12.0 ± 1.2 preinjection, 3.3 ± 2.9 one year postinjection, and 72.5% WOMAC pain improvement). There was significant positive correlation between white blood cell concentration in APS and improvement in WOMAC pain scores.

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The cyclops lesion is a localized anterior arthrofibrosis most commonly seen following anterior cruciate ligament reconstruction. The lesion forms at the anterior cruciate ligament insertion creating a painful extension block between femoral intercondylar notch and tibial plateau. We present 2 cases (3 knees) in which cyclops lesions appeared atypically following bicruciate-retaining total knee replacement. Two lesions occurred in a single patient following bilateral knee replacement. One lesion occurred in an active sportswoman. All 3 resolved following arthroscopic debridement. We describe the presentation of this unusual complication and suggest keys to its diagnosis, treatment, and prevention.

Activated blood platelets play a critical, early role in the wound healing response by releasing several types of growth factors at the site of injury which mediate the initial stages of tissue repair. Autologously derived platelet-rich plasma has been applied during surgery as a healing aid and some studies have shown benefit with total joint arthroplasty procedures such as in the knee. However, little has been published regarding the use of platelet-rich plasma during total hip arthroplasty. The hip is especially prone to develop islands of heterotopic bone following arthroplasty which can lead to pain, limited motion, and even ankylosis of the joint. If this condition is exacerbated by platelet-rich plasma, this could present a barrier to the use of this adjuvant in total hip arthroplasty. This retrospective, controlled clinical study examined the effect of platelet rich plasma application during closure following total hip arthroplasty on heterotopic ossification. By one year, 21.3% of the control patients developed heterotopic bone (91 patients, 94 hips, Brooker grades I-III) compared to 12.9% of the treatment patients (76 patients, 85 hips, Brooker grades I-II). These differences were not significant (p = 0.478, power = 0.90). Thus, the use of platelet-rich plasma in this procedure does not appear to influence the incidence or severity of heterotopic ossification which should help to justify further clinical research to more fully understand whether this autologous blood product has a role in total hip arthroplasty.