Objective assessment of intraoperative skills for robot-assisted partial nephrectomy (RAPN).

RAPN training usually takes place in-vivo and methods vary across countries/institutions. No common system exists to objectively assess trainee capacity to perform RAPN at predetermined performance levels prior to in-vivo practice. The identification of objective performance metrics for RAPN training is a crucial starting point to improve training and surgical outcomes. The authors sought to examine the reliability, construct and discriminative validity of objective intraoperative performance metrics which best characterize the optimal and suboptimal performance of a reference approach for training novice RAPN surgeons. Seven Novice and 9 Experienced RAPN surgeons video recorded one or two independently performed RAPN procedures in the human. The videos were anonymized and two experienced urology surgeons were trained to reliably score RAPN performance, using previously developed metrics. The assessors were blinded to the performing surgeon, hospital and surgeon group. They independently scored surgeon RAPN performance. Novice and Experienced group performance scores were compared for procedure steps completed and errors made. Each group was divided at the median for Total Errors score, and subgroup scores (i.e., Novice HiErrs and LoErrs, Experienced HiErrs and LoErrs) were compared. The mean inter-rater reliability (IRR) for scoring was 0.95 (range 0.84-1). Compared with Novices, Experienced RAPN surgeons made 69% fewer procedural Total Errors. This difference was accentuated when the LoErr Expert RAPN surgeon's performance was compared with the HiErrs Novice RAPN surgeon's performance with an observed 170% fewer Total Errors. GEARS showed poor reliability (Mean IRR = 0.44; range 0.0-0.8), for scoring RAPN surgical performance. The RAPN procedure metrics reliably distinguish Novice and Experienced surgeon performances. They further differentiated performance levels within a group with similar experiences. Reliable and valid metrics will underpin quality-assured novice RAPN surgical training.

International Expert Consensus on Metric-based Characterization of Robot-assisted Partial Nephrectomy.

BACKGROUND: Robot-assisted partial nephrectomy (RAPN) training usually takes place in vivo, and methods vary across countries/institutions. No common system exists to objectively assess trainee ability to perform RAPN at predetermined performance levels prior to in vivo practice. The identification of objective performance metrics for RAPN training is a crucial starting point to improve training and surgical outcomes. OBJECTIVE: We sought to identify objective performance metrics that best characterize a reference approach to RAPN, and obtain face and content validity from procedure experts through a modified Delphi meeting. DESIGN, SETTING, AND PARTICIPANTS: During a series of online meetings, a core metrics team of three RAPN experts and a senior behavioral scientist performed a detailed task deconstruction of a transperitoneal left-sided RAPN procedure. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Based on published guidelines, manufacturers' instructions, and unedited videos of RAPN, the team identified performance metrics that constitute an optimal approach for training purposes. The metrics were then subjected to an in-person modified international Delphi panel meeting with 19 expert surgeons. RESULTS AND LIMITATIONS: Eleven procedure phases, with 64 procedure steps, 43 errors, and 39 critical errors, were identified. After the modified Delphi process, the international expert panel added 13 metrics (two steps), six were deleted, and three were modified; 100% panel consensus on the resulting metrics was obtained. Limitations are that the metrics are applicable only to left-sided RAPN cases and some might have been excluded. CONCLUSIONS: Performance metrics that accurately characterize RAPN procedure were developed by a core group of experts. The metrics were then presented to and endorsed by an international panel of very experienced peers. Reliable and valid metrics underpin effective, quality-assured, structured surgical training for RAPN. PATIENT SUMMARY: We organize a meeting among robot-assisted partial nephrectomy (RAPN) experts to identify and reach consensus on objective performance metrics for RAPN training. The metrics are a crucial starting point to improve and quality assure surgical training and patients' clinical outcomes.

Longitudinal prospective long-term radiographic follow-up after treatment of single-level cervical disk disease with the Bryan Cervical Disc.

BACKGROUND: Many short- and intermediate-term radiological and clinical studies on cervical arthroplasty with the Bryan Cervical Disc have been published, providing, most of the time, satisfactory results. OBJECTIVE: To prospectively assess the intermediate and long-term radiographic characteristics of disk replacement surgery with the Bryan Cervical Disc and to correlate these results with clinical outcome. METHODS: Range of motion was measured with a validated tool. Intervertebral disk degeneration was assessed with a quantitative scoring system. Heterotopic ossification was evaluated with a previously published scoring system. Device stability was investigated by measuring subsidence and anteroposterior migration. General clinical patient outcome was assessed with the Odom classification system. RESULTS: Eighty-nine patients were initially included in this prospective long-term study. One patient was reoperated on at the index level and 4 were reoperated on at an adjacent level; those patients were not further analyzed. The mobility at the treated level was preserved in > or = 85% of our cases. The insertion of the prosthesis did not lead to an increase in mobility at the adjacent levels. The degeneration score increased at both adjacent levels. Heterotopic ossification was present in 34% to 39% of the patients, depending on the follow-up point. No cases of anteroposterior migration or subsidence were found. More than 82% of all patients had a good to excellent clinical outcome in the long run. CONCLUSION: The device maintains preoperative motion at the index and adjacent levels, seems to protect against acceleration of adjacent-level degeneration as seen after anterior cervical discectomy and fusion, and remains securely anchored in the adjacent bone mass in the long run. Heterotopic ossification was frequently seen. The vast majority of all patients had a good to excellent clinical outcome.

Effect of implant surface roughness and loading on peri-implant bone formation.

BACKGROUND: Critical factors for the establishment of osseointegration are the implant surface microtopography and the local mechanical environment. The present study evaluated the bone response around a turned (T) and a roughened (R) implant for either an unloaded or a well-controlled loaded situation. METHODS: Bone chambers were installed in the tibia of 20 rabbits. In each of the chambers, two identical displacement-controlled loading experiments were performed: 30 microm for 400 cycles at 1 Hz, three times a week for 9 weeks versus 0-microm implant displacement. A linear mixed model and a logistic mixed model with alpha = 5% were set to study the significant effect of the surface texture on the peri-implant bone response in the unloaded (T-0 microm versus R-0 microm) and the loaded (T-30 microm versus R-30 microm) mode. RESULTS: Results indicated no microtopographic dependence of the bone response further away from the implant in unloaded and loaded conditions. For a load-free implant, osseointegration seemed to occur with a higher incidence at a roughened compared to a turned implant surface. In the presence of loading, the topographic dependency of the osteogenic activity at the interface was overruled by the loading-related bone response, revealing no significant differences in osseointegration incidence between T and R. CONCLUSION: A predominant effect of the interfacial mechanical environment over the implant surface characteristics on the differentiating cell population is suggested.

Influence of controlled immediate loading and implant design on peri-implant bone formation.

AIM: Tissue formation at the implant interface is known to be sensitive to mechanical stimuli. The aim of the study was to compare the bone formation around immediately loaded versus unloaded implants in two different implant macro-designs. MATERIAL AND METHODS: A repeated sampling bone chamber with a central implant was installed in the tibia of 10 rabbits. Highly controlled loading experiments were designed for a cylindrical (CL) and screw-shaped (SL) implant, while the unloaded screw-shaped (SU) implant served as a control. An F-statistic model with alpha=5% determined statistical significance. RESULTS: A significantly higher bone area fraction was observed for SL compared with SU (p<0.0001). The mineralized bone fraction was the highest for SL and significantly different from SU (p<0.0001). The chance that osteoid- and bone-to-implant contact occurred was the highest for SL and significantly different from SU (p<0.0001), but not from CL. When bone-to-implant contact was observed, a loading (SL versus SU: p=0.0049) as well as an implant geometry effect (SL versus CL: p=0.01) was found, in favour of the SL condition. CONCLUSIONS: Well-controlled immediate implant loading accelerates tissue mineralization at the interface. Adequate bone stimulation via mechanical coupling may account for the larger bone response around the screw-type implant compared with the cylindrical implant.

The effect of micro-motion on the tissue response around immediately loaded roughened titanium implants in the rabbit.

Initial osteogenesis at the implant interface is, to a great extent, determined by the implant surface characteristics and the interfacial loading conditions. The present study investigated the effect of various degrees of relative movement on the tissue differentiation around a roughened screw-shaped immediately loaded implant. Repeated-sampling bone chambers were installed in the tibia of 10 rabbits. In each of the chambers, three experiments were performed by inducing 0 (control), 30, and 90 microm implant displacement for 9 wk. A linear mixed model and a logistic mixed model with alpha = 5% determined statistical significance. Tissue filling of the bone chamber was similar for the three test conditions. The bone area fraction was significantly higher for 90 microm implant displacement compared with no displacement. A significantly higher fraction of bone trabeculae was found for 30 and 90 microm implant displacement compared with the unloaded situation. The incidence of osteoid-to-implant and bone-to-implant contact was significantly higher for 90 microm implant displacement compared with 30 and 0 microm implant displacement. Significantly more osteoid in contact with the implant was found for the loaded conditions compared with no loading. Well-controlled micro-motion positively influenced bone formation at the interface of a roughened implant. An improved bone reaction was detected with increasing micro-motion.