Pelvic Intraoperative Neuromonitoring Prevents Dysfunction in Patients With Rectal Cancer: Results From a Multicenter, Randomized, Controlled Clinical Trial of a NEUROmonitoring System (NEUROS).

OBJECTIVE: This NEUROmonitoring System (NEUROS) trial assessed whether pelvic intraoperative neuromonitoring (pIONM) could improve urogenital and ano-(neo-)rectal functional outcomes in patients who underwent total mesorectal excisions (TMEs) for rectal cancer. BACKGROUND: High-level evidence from clinical trials is required to clarify the benefits of pIONM. METHODS: NEUROS was a 2-arm, randomized, controlled, multicenter clinical trial that included 189 patients with rectal cancer who underwent TMEs at 8 centers, from February 2013 to January 2017. TMEs were performed with pIONM (n=90) or without it (control, n=99). The groups were stratified according to neoadjuvant chemoradiotherapy and sex, with blocks of variable length. Data were analyzed according to a modified intention-to-treat protocol. The primary endpoint was a urinary function at 12 months after surgery, assessed with the International Prostate Symptom Score, a patient-reported outcome measure. Deterioration was defined as an increase of at least 5 points from the preoperative score. Secondary endpoints were sexual and anorectal functional outcomes, safety, and TME quality. RESULTS: The intention-to-treat analysis included 171 patients. Marked urinary deterioration occurred in 22/171 (13%) patients, with significantly different incidence between groups (pIONM: n=6/82, 8%; control: n=16/89, 19%; 95% confidence interval, 12.4-94.4; P =0.0382). pIONM was associated with better sexual and ano-(neo)rectal function. At least 1 serious adverse event occurred in 36/88 (41%) in the pIONM group and 53/99 (54%) in the control group, none associated with the study treatment. The groups had similar TME quality, surgery times, intraoperative complication incidence, and postoperative mortality. CONCLUSION: pIONM is safe and has the potential to improve functional outcomes in rectal cancer patients undergoing TME.

Autologous Iliac Bone Graft Compared with Biphasic Hydroxyapatite and Calcium Sulfate Cement for the Treatment of Bone Defects in Tibial Plateau Fractures: A Prospective, Randomized, Open-Label, Multicenter Study.

BACKGROUND: Bone-graft substitutes are commonly used for the augmentation of traumatic bone defects in tibial plateau fractures. However, their clinical performance compared with that of autologous bone-grafting, the gold standard in bone defect reconstruction, still remains under debate. This study investigates the differences in quality of life, pain, and radiographic outcomes in the treatment of tibial plateau fracture-associated bone defects with either autologous bone grafts or a bioresorbable hydroxyapatite and calcium sulfate cement (CERAMENT BONE VOID FILLER [CBVF]; BONESUPPORT). METHODS: In this study, 135 patients with acute depression and split-depression fractures of the proximal part of the tibia (OTA/AO types 41-B2 and 41-B3) were enrolled in a prospective, controlled, randomized, multicenter trial including 20 hospitals in Germany. Patients were randomized to receive either autologous iliac bone graft or CBVF for reconstruction of the bone defect. The primary outcome measures were the Short Form (SF)-12 version 2 Physical Component Summary (PCS) score at week 26 (the study was designed to show noninferiority of the CBVF with regard to the PCS with a prespecified margin of -5 points) and the pain level at 26 weeks postoperatively measured by a visual analog scale (VAS). The secondary outcomes were the SF-12 version 2 Mental Component Summary (MCS) and SF-12 PCS scores at weeks 1, 6, and 12 and bone-healing on radiographs. RESULTS: Age, sex, fixation methods, and fracture pattern were comparable in both groups. There were no significant differences (p > 0.05) in the SF-12 PCS or VAS scores at postoperative week 26. There was a significant reduction of blood loss (p = 0.007) and pain levels (p = 0.008) at postoperative day 1 in the CBVF group. The rates of fracture-healing, defect remodeling, and articular subsidence were not significantly different (p > 0.05) in both groups. CONCLUSIONS: Bioresorbable CBVF was noninferior to autologous bone graft with regard to both patient-reported and radiographic outcomes in tibial plateau fractures of OTA/AO types 41-B2 and 41-B3. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

CERAMENT treatment of fracture defects (CERTiFy): protocol for a prospective, multicenter, randomized study investigating the use of CERAMENT™ BONE VOID FILLER in tibial plateau fractures.

BACKGROUND: Bone graft substitutes are widely used for reconstruction of posttraumatic bone defects. However, their clinical significance in comparison to autologous bone grafting, the gold-standard in reconstruction of larger bone defects, still remains under debate. This prospective, randomized, controlled clinical study investigates the differences in pain, quality of life, and cost of care in the treatment of tibia plateau fractures-associated bone defects using either autologous bone grafting or bioresorbable hydroxyapatite/calcium sulphate cement (CERAMENT™|BONE VOID FILLER (CBVF)). METHODS/DESIGN: CERTiFy (CERament™ Treatment of Fracture defects) is a prospective, multicenter, controlled, randomized trial. We plan to enroll 136 patients with fresh traumatic depression fractures of the proximal tibia (types AO 41-B2 and AO 41-B3) in 13 participating centers in Germany. Patients will be randomized to receive either autologous iliac crest bone graft or CBVF after reduction and osteosynthesis of the fracture to reconstruct the subchondral bone defect and prevent the subsidence of the articular surface. The primary outcome is the SF-12 Physical Component Summary at week 26. The co-primary endpoint is the pain level 26 weeks after surgery measured by a visual analog scale. The SF-12 Mental Component Summary after 26 weeks and costs of care will serve as key secondary endpoints. The study is designed to show non-inferiority of the CBVF treatment to the autologous iliac crest bone graft with respect to the physical component of quality of life. The pain level at 26 weeks after surgery is expected to be lower in the CERAMENT bone void filler treatment group. DISCUSSION: CERTiFy is the first randomized multicenter clinical trial designed to compare quality of life, pain, and cost of care in the use of the CBVF and the autologous iliac crest bone graft in the treatment of tibia plateau fractures. The results are expected to influence future treatment recommendations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT01828905.