Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial.

OBJECTIVE: Evaluate the efficacy and safety/tolerability of cryoneurolysis for reduction of pain and symptoms associated with knee osteoarthritis (OA). DESIGN: Randomized, double-blind, sham-controlled, multicenter trial with a 6-month follow-up in patients with mild-to-moderate knee OA. Patients were randomized 2:1 to cryoneurolysis targeting the infrapatellar branch of the saphenous nerve (IPBSN) or sham treatment. The primary endpoint was the change from baseline to Day 30 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain score adjusted by the baseline score and site. Secondary endpoints, including visual analogue scale (VAS) pain score and total WOMAC score, were tested in a pre-defined order. RESULTS: The intent-to-treat (ITT) population consisted of 180 patients (n = 121 active treatment, n = 59 sham treatment). Compared to the sham group, patients who received active treatment had a statistically significant greater change from baseline in the WOMAC pain subscale score at Day 30 (P = 0.0004), Day 60 (P = 0.0176), and Day 90 (P = 0.0061). Patients deemed WOMAC pain responders at Day 120 continued to experience a statistically significant treatment effect at Day 150. Most expected side effects were mild in severity and resolved within 30 days. The incidence of device- or procedure-related adverse events was similar in the two treatment groups with no occurrence of serious or unanticipated adverse device effects (ADE). CONCLUSIONS: Cryoneurolysis of the IPBSN resulted in statistically significant decreased knee pain and improved symptoms compared to sham treatment for up to 150 days, and appeared safe and well tolerated.

Osteonecrosis of the femoral head associated with slipped capital femoral epiphysis.

We performed a retrospective analysis of 212 patients (299 hips) with slipped capital femoral epiphysis (SCFE) over a 9-year period to assess the incidence of osteonecrosis of the femoral head. Risk factors for the occurrence of osteonecrosis and the influence of treatment on the development of osteonecrosis were determined. Osteonecrosis occurred in 4 hips with unstable SCFE (4/27) and did not occur in hips with stable SCFE (0/272). The proportion of hips in which osteonecrosis developed was significantly higher among the unstable hips (4/27 vs. 0/272, p < 0.0001). Among those with an unstable hip, younger age at presentation was a predictor of a poorer outcome. Magnitude of the slip, magnitude of reduction, and chronicity of the slip were not predictive of a poorer outcome in the unstable group. In situ fixation of the minimally or moderately displaced "unstable" SCFE demonstrated a favorable outcome. We have identified the hip at risk as an unstable SCFE. The classification of hips as unstable if the epiphysis is displaced from the metaphysis or if the patient is unable to walk is most useful in predicting a hip at risk for osteonecrosis.

Sonography of ovarian tumors: predictability of tumor type.

One hundred six ovarian neoplasms were evaluated with respect to size, echogenic characteristics, and percentage of echogenic material to determine if sonography could differentiate between malignant and benign tumors and if histology could be determined. This study indicates that anechoic lesions have high likelihood of being benign tumors, usually mucinous cystadenomas or serous cystadenomas. As the percentage of echogenic material increases, the likelihood of malignancy also increases. There are two exceptions to this rule. The first is lesions with very echogenic foci, which are virtually always benign teratomas. The second is groups of tumors that are totally or near-totally echogenic. These are actually less likely to be malignancies than mixed-density tumors that have a large anechoic component. In mixed-echogenicity tumors that are not teratomas, there was no way of distinguishing between benign and malignant lesions with an acceptable degree of accuracy in an individual case. Also, with the exception of teratomas, histology could not be determined. It should be noted that in the postmenopausal patient, the maximum size of a normal ovary is 2 X 1.5 X 0.5 cm. An adnexal mass larger than this must be considered suspicious of a neoplasm.