Supporting Evidence

ZBEdge is a suite of integrated digital and robotic technologies, built to unlock data-powered insights across the continuum of care.

Zimmer Biomet is committed to supporting the value of our technology with evidence. Read below for the latest on our ZBEdge products.


ROSA® Knee System

PUBLICATION

An anatomo-functional implant positioning technique with robotic assistance for primary TKA allows the restoration of the native knee alignment and a natural functional ligament pattern, with a faster recovery at 6 months compared to an adjusted mechanical technique. 


Parratte S, Van Overschelde P, Bandi M, Ozturk BY, Batailler C. Knee Surg Sports Traumatol Arthrosc. 2022.

Key Takeaway: Faster recovery using an anatomo-functional implant positioning (AFIP) technique for robotic total knee arthroplasty compared to an adjusted mechanical alignment (aMA) technique.

“The AFIP concept allowed the restoration of the native knee anatomy and alignment with a natural ligament pattern.

With a more physiological target for ligament balancing, robotically-assisted AFIP technique had equivalent clinical outcomes at 12 months compared to aMA, with a faster recovery”

PUBLICATION

Comparative outcomes between a new robotically assisted and a manual technique for total knee arthroplasty in patients with osteoarthritis: a prospective matched comparative cohort study. 


Kenanidis E, Paparoidamis G, Milonakis N, Potoupnis M, Tsiridis E. European Journal of Orthopaedic Surgery & Traumatology. 2022.

Key Takeaway: raTKA was associated with the same complication risk, less pain level, better patient satisfaction, and PROMs on 6-month follow-up than the mTKA group.

“One of the first comparative clinical studies evaluating outcome differences between ROSA raTKA and mTKA”, and the “results indicate that raTKA may help enhance the early functional recovery of TKA patients and promote a better satisfaction level in the early postoperative period.”

PUBLICATION

Total Knee Arthroplasty With Robotic Surgical Assistance Results in Less Physician Stress and Strain Than Conventional Methods


Haffar A, Krueger CA, Goh GS, Lonner JH. 2022 Jun;37(6S):S193-S200.

Key Takeaway: Robotic assistance may help to increase surgical efficiency and reduce physician workload

Total energy expenditure was lower in robotic TKA than conventional TKA. Average heart rate was lower in robotic TKA. Robotic TKA resulted in less lumbar flexion and a reduction in the time spent in demanding lumbar flexion. Neck rotation was significantly reduced by robotic TKA.

PUBLICATION

Is sequential bilateral robotic total knee arthroplasty a safe procedure? A matched comparative pilot study.


Batailler C, Anderson MB*, Flecher X, Ollivier M, Parratte S. Archives of Orthopaedic and Trauma Surgery 2022.

Key Takeaway: Sequential bilateral TKA performed with robotic assistance more accurately restores knee alignment with similar perioperative outcomes and better Knee Society functional scores at six months postoperative compared to conventional instrumentation, despite a longer surgical time.

Bilateral sequential TKA is a valid option for improving accuracy and early outcomes, without posing an additional risk of complications.

PUBLICATION

A Personal Journey through, and review of, the Landscape of Surgical Robotics in Knee Arthroplasty: My Transition from Mako® to NAVIO™ and finally to the ROSA® Knee System+


Lonner H. Jess, Journal of Orthopaedic Experience & Innovation 2022.

Key Takeaway: The potential of the confluence of the ROSA Knee System and analytics platforms to simplify the surgical procedure, improve accuracy, and provide a vehicle for mass customization and individualization of care for each patient is a noteworthy advance.

Dr. Lonner concludes that the value of contemporary knee robotics may not yet be fully appreciated, which is emphasized by the prospects of advancing AI with pre, intra, and post-operative data in order to further optimize outcomes for TKA. He feels that robotics in arthroplasty is on the verge of becoming “self-evident”.

REGISTRY DATA

Promising Results for Early Survivorship with the ROSA Knee System; An Automated Report from the Australian Orthopaedic Association National Joint Replacement Registry


Anderson, Mike B* and Konstanze Hueller*, Zimmer Biomet White Paper, May 2021.

Key Takeaway: 35% relative reduction in early revision rates

The survivorship reported within the AOANJRR of Persona® Knee implants combined with early data from the ROSA Knee System is promising. The CPR for Persona Knee CR and PS bearings is 1.9 (95% CI, 1.6 – 2.2) at five years, compared to a CPR of 3.4 (95% CI, 3.4-3.5) for the same follow-up time with all other total knees. The revisions/100 observation years was 0.39 (95% CI, 0.14 – 0.86) for robotic assisted TKA using the Persona knee compared to 0.60 (95% CI, 0.52– 0.68) without robotic assistance for the same implants. This demonstrates a relative reduction in revisions of 35% when robotic assistance was used.

PUBLICATION

The initial learning curve for the ROSA® Knee System can be achieved in 6-11 cases for operative time and has similar 90-day complication rates with improved implant alignment compared to manual instrumentation in total knee arthroplasty.


Vanlommel, Luc, Enrico Neven, Mike B. Anderson*, Liesbeth Bruckers, Jan Truijen. Journal of Experimental Orthopaedics (2021) 8:119

Key Takeaway: The data demonstrated a relatively rapid learning curve for operative times associated with adoption of this novel robotic system.

As the digital age of medicine continues to develop, advanced technologies may disrupt the industry, but should not disrupt the care provided. This cutting guide positioning robotic system can be integrated relatively quickly with a rapid initial learning curve (6-11 cases) for operative times, similar 90-day complication rates, and improved component positioning compared to mTKA. Proficiency of the system requires additional analysis, but it can be expected to improve over time.

PUBLICATION

Using Standard X-ray Images to Create 3D Digital Bone Models and Patient-Matched Guides for Aiding Implant Positioning and Sizing in Total Knee Arthroplasty+


Massé, Vincent and Raju S. Ghate. Computer Assisted Surgery, 26:1, 31-40, published online 15 Mar 2021

Key Takeaway: X-Atlas™ imaging technology could effectively predict implant sizing.

The X-Atlas™ imaging technology proved to be accurate to reconstruct a 3D bone model and results have shown that it might provide benefits to surgeons seeking improved planning and precision without the problems of obtaining 3D imaging.

POSTER

High Interobserver Reliability of Bone and Soft Tissue Registration in A Robotic TKA Platform.  


Charette, MD, Ryan S; Nana O. Sarpong, MD, MBA; Roshan P Shah, MD; Herbert John Cooper, MD. American Association of Hip and Knee Surgeons Annual Meeting. November, 2021. Poster 162

Key Takeaway: Registration of anatomic landmarks and dynamic soft tissue assessment can be performed with excellent reliability using the imageless version of ROSA.

There was excellent repeatability using imageless software between all evaluators and across all training levels (ρc>0.92). Image-guided specimens showed a greater correlation than imageless specimens (ρc >= 0.98). Measurements of maximum soft tissue laxity in medial and lateral flexion and extension spaces demonstrated the highest concordance (all ρc >0.99).

PUBLICATION

High accuracy of a new robotically assisted technique for total knee arthroplasty: an in vivo study. 


Rossi SMP, Sangaletti R, Perticarini L, Terragnoli F, Benazzo F. Knee Surg Sports Traumatol Arthrosc 2022

Key Takeaway: The ROSA Knee system demonstrated a high degree of in vivo accuracy.

The average difference between planned and validated measures were below 1 mm or under 1 degree with SD < 1.

The average difference between planned HKA and measured was 1.2 ± 1.1 degrees.

“…using this new surgical robot in total knee arthroplasty [makes it] possible to perform accurate bone cuts and to achieve the planned angles and resections.”

ROSA®  Partial Knee System

PUBLICATION

Improved Accuracy and Reproducibility of a Novel CT‑Free Robotic Surgical Assistant for Medial Unicompartmental Knee Arthroplasty Compared to Conventional Instrumentation: A Cadaveric Study+


Lonner, J.H., Seidenstein, A.D., Charters, M.A. et al.  Knee Surg Sports Traumatol Arthrosc (2021). https://doi.org/10.1007/s00167-021-06626-4

Key Takeaway: ROSA Partial Knee cases resulted in significantly more accurate and more reproducible bone resection angles than conventional instrumentation

The purpose of this study was to determine whether a novel CT-free robotic surgical assistant improves the accuracy and reproducibility of bone resections in UKA compared to conventional manual instrumentation.  All bone resection angles were significantly more accurate for robotic cases. Highly accurate bone resection angles to 1° in the coronal and sagittal planes. Four out of five parameters were significantly more reproducible (fewer outliers). 97% of cases were within 3° of targeted Tibia V/V and A/P, as well as Femur V/V and F/E.

WHITE PAPER

First Experiences with ROSA® Partial Knee System: Case Presentations


Cafferky, Nathan L., Luminita Stoenica*, Mike B. Anderson*, Christopher Cannova. White Paper. October 2021.

Key Takeaway: ROSA Partial Knee is versatile and is able to accommodate complex and straight-forward cases.

This paper describes the first two PKA cases performed in the United States with the newly launched ROSA Partial Knee System. The two different cases illustrate the versatility of the ROSA Partial Knee System being able to accommodate complex situations and straightforward cases. The implementation of robotic-assisted PKA in operating theaters could potentially improve the reproducibility of the surgical technique and eliminate differences in component positioning between high and low volume surgeons.

ROSA® Hip System

PUBLICATION

Improved accuracy and fewer outliers with a novel CT‑free robotic THA system in matched‑pair analysis with manual THA+


Kamath, Atul, F., Sridhar M. Durbhakula, Trevor Pickering, Nathan L. Caferky, Trevor G. Murray, Michael A. Wind Jr., Stéphane Méthot*. Journal of Robotic Surgery. Published online: 28 October 2021.

Key Takeaway: ROSA Hip demonstrated more accurate acetabular cup positioning and resulted in fewer outliers compared to manual THA.

For all parameters studied – including cup inclination and version, leg length discrepancy and cup placement compared to target – the robotic group had an improved accuracy and lower variance (fewer outliers) vs conventional instrumentation.

mymobility®

PUBLICATION

2021 Mark Coventry Award: Use of a Smartphone-Based Care Platform After Primary Partial and Total Knee Arthroplasty: A Prospective Randomized Controlled Trial+


Crawford, David et al. Bone Joint J 2021;103-B (6 Supple A) : 3-12 

Key Takeaway: Equivalent outcomes and significantly fewer PT visits with mymobility for TKA/PKA

The purpose of this study was to determine the non-inferiority of a smartphone-based exercise educational care management system after primary knee arthroplasty compared with a traditional in-person physiotherapy rehabilitation model. The data found that mymobility is clinically non-inferior to the standard of care for all outcomes. mymobility users demonstrated a significant reduction of physical therapy utilization post-operatively. Further, mymobility users trended lower on ED visits than control group, though not statistically significant. This platform could aid in decreasing post-operative costs, while improving patient engagement and communication with the healthcare team.

PUBLICATION

Early Outcomes of Primary Total Hip Arthroplasty with Use of a Smartphone-Based Care Platform: A Prospective Randomized Controlled Trial+


Crawford, David et al Bone Joint J 2021;103-B (7 Supple B):91-97.

Key Takeaway: Equivalent outcomes and significantly fewer PT visits with mymobility for THA

The purpose of this study was to determine the non-inferiority of a smartphone-based exercise educational care management system after primary total hip arthroplasty compared with a traditional in-person physiotherapy rehabilitation model. The data found that mymobility is clinically non-inferior to the standard of care for all outcomes. mymobility users demonstrated a significant reduction of physical therapy utilization post-operatively. Further, mymobility users trended lower on ED visits than the control group and hospital readmissions, though not statistically significant. This platform could aid in decreasing post-operative costs, while improving patient engagement and communication with the healthcare team.

ABSTRACT

Feasibility of Passively Collected Gait Parameters Using a Smart-Phone Based Care Platform Following Total Hip and Knee Arthroplasty+


M. Anderson*, D. Van Andel*, J. Foran, I. Mance, E. Arnold. Orthopaedic Proceedings Vol. 103-B, No. SUPP_9, Published online 15 June 2021.

Key Takeaway: mymobility enables remote gait quality measurements

The purpose of this study was to assess the recovery of gait quality following primary total hip and knee arthroplasty using a smart-phone based care management platform. The recovery curves reflect previous curves captured by traditional gait analysis methods as well as functional and patient reported outcome scores. Capturing real-world gait quality metrics through the phone may provide further insights into objective recovery data not captured by traditional in-clinic assessments.

ABSTRACT

The Recovery Curve for Physical Activity Following Primary Knee Arthroplasty Using Passively Collected Objective Measures with a Smart-phone Based Care Platform and Smart Watch+


M. Anderson*, D. Van Andel*, C.L. Israelite, C. Nelson. Orthopaedic Proceedings. Volume 103-B, No. SUPP_9, Published online 15 June 2021 

Key Takeaway: Objective and reliable data with mymobility

The purpose of this study was to characterize the recovery of physical activity following knee arthroplasty by means of step counts and flight counts (flights of stairs) measured using a smart-phone based care platform.  This data demonstrated a recovery curve similar to previously reported curves for patient reported outcome measures in the arthroplasty arena. Patients and surgeons may use this information to help set goals for recovery following total and partial knee arthroplasty using objective activity measures.

WHITE PAPER

Technology Adoption for Health Care Management Among Older Adults: Embracing App-Based Technology as a Means for Better Managing Post-Operative Care After Arthroplasty


Zimmer Biomet, White Paper, March 2021.

Key Takeaway: Older adults adopt technology.

Older adults are demonstrating a continued and significant adoption of technology. Moreover, baby boomers are increasingly eager to have their health care needs managed through a combination of technology and traditional health care.

OrthoIntel Orthopedic Intelligence Platform

ABSTRACT

Passive Data Collection Across the 6-Week Episode of Care, the Next Evolution in Contemporary Patient Outcomes Monitoring in Total Knee Arthroplasty


Anderson, M.*, J. Lonner, D. Van Andel*, J.C. Ballard. Orthopaedic Proceedings. Volume 103-B, No. SUPP_9. Published online 15 June 2021

Key Takeaway: First-ever example of identifying treatment trends with combination of ROSA and mymobility data in a commercial database

The purpose of the study was to demonstrate the feasibility of passively collecting objective, anonymized data from a commercially available smartphone-based care management platform (sbCMP) and robotic assisted total knee arthroplasty (raTKA). The use of passively collected objective measures in a commercial database across the episode of care was feasible and demonstrated associations between intraoperative and post-operative metrics. 

This is the first integrated data collection and reporting platform to demonstrate  these measures in a commercial population.

OptiVu™ Mixed Reality

PUBLICATION

Looking through the Lens: The Reality of Telesurgical Support with Interactive Technology Using Microsoft’s HoloLens 2. 


Kees van der Putten*, Mike B. Anderson*, and Rutger C. van Geenen. Case Reports in Orthopedics, vol. 2022, Article ID 5766340, 5 pages, 2022. 

Key Takeaway: Microsoft HoloLens 2 was used for unplanned remote assistance for telesurgical support.

This case study demonstrates the ability to use the HoloLens 2 with Microsoft Dynamics 365 Remote Assist Software to provide immediate telesurgical support by an industry representative, the PM, to the operating surgeon approximately 100 km apart. The data is transferred via an encrypted and secured cloud-based program and provided the PM a real-time surgeon viewpoint of the operating theatre, including direct line of site to the operative knee, the operating instruments, and even the surgeon’s hands.