BACKGROUND CONTEXT Lumbar total disc replacement (TDR) was introduced in the 1980s and is becoming more common. Anecdotally, there have been reports of patients reporting the onset of new leg pain following TDR surgery. To date, there has been little formal investigation into this clinical phenomenon. PURPOSE The purpose of this study was to determine the incidence of new-onset leg pain following lumbar TDR and investigate treatment strategies for this occurrence. STUDY DESIGN/SETTING This study was based on a post hoc analysis of data collected prospectively as part of an FDA IDE trial. PATIENT SAMPLE The study population was comprised of 283 patients who received ProDisc-L or activL® as part of the multicenter, randomized FDA IDE trial for the latter device. Patients were treated for symptomatic single-level disc degeneration unresponsive to at least 6 months of nonoperative care. OUTCOME MEASURES The primary outcome measures in the study were the onset of leg pain following TDR surgery and the outcomes of treatments for this condition. METHODS New onset of leg pain following TDR surgery was identified from adverse event reports collected prospectively during the trial. It was defined as leg pain beginning 0- to 4 weeks postoperatively. The treatment of these symptoms was at the operating surgeon's discretion. Treatment strategies were classified as: medication, nonoperative care, injections, and/or subsequent surgery. RESULTS New onset of postoperative leg pain occurred in 9.2% of lumbar TDR patients (26/283). The new onset pain resolved in 76.9% (20/26) of patients. Most patients (24 of 26) were treated with one or more medications, the most common of which was anticonvulsant drugs such as gabapentin or pregabalin, commonly used to treat neurogenic-type pain. Symptoms resolved in 75% of patients receiving this type of medication. Some also received narcotics and 30.8% were treated with steroids, most commonly a Medrol dose-pack. Twelve patients received other nonoperative care (PT, acupuncture, etc.) and 7 received injections. Three patients went on to have subsequent surgery, none of whom had resolution of the new onset leg pain after the additional procedure. Among the 20 patients whose new symptoms resolved, resolution occurred within 3 months in 11 patients. CONCLUSIONS Early-onset postoperative leg pain occurred in approximately 10% of lumbar TDR patients. The source of the symptoms is not clear. In the majority of patients, the new symptoms resolved, often within 3 months of onset. While challenging to definitively evaluate in this relatively small subset of patients, it appears the most effective treatment strategy is gabapentin or pregabalin. The role of other nonoperative interventions could not be discerned. Surgical re-intervention is likely unnecessary and did not lead to resolution of early onset leg pain post-TDR. FDA DEVICE/DRUG STATUS activL and ProDisc-L (Approved for this indication).