Intelligent Customer-driven Solution for Orthopedic and Pediatric Surgery Care (ICory): Final Report

This report summarizes main activities and achieved results of the ICory project, a co-innovation project funded by Business Finland and carried out during 2018-2021. ICory aimed at 1) co-creating an intelligent patient-centric digital solution for orthopedic and pediatric surgery care journeys; 2) assessing impact of the developed solution from both medical, patient, and business perspectives; 3) and developing ecosystemic business model for speeding up companies’ access to the international market. In ICory, the patient journey solutions were co-developed together with researchers, hospitals, and companies; effectiveness of the solutions were evaluated in two randomized controlled trials in Finland; Rehaboo! Exercise Game is being evaluated in a RCT in Singapore; a medicine delivery robot was developed and tested; research on business models was conducted; collaboration with three hospitals in Singapore and one Australian University was built. Results of the studies have been published in 27 scientific journal and conferences articles, and 2 doctoral dissertations were done during the project. The COVID-19 pandemic has affected functioning of the participating hospitals, delaying recruitment of patients and progression of the RCT studies. Analysis of the RCT data has started and the results will be published in several scientific articles after the project

Implant survival of constrained acetabular device in primary total hip arthroplasty based on data from the Finnish Arthroplasty Register

Background: Constrained acetabular devices were developed to prevent dislocations after total hip arthroplasty (THA). However, the data on their success have been contradictory. In this study, we aimed to assess implant survival of the constrained acetabular device in primary THA based on the Finnish Arthroplasty Register data. Methods: A total of 373 primary THAs with constrained acetabular devices inserted from 2006 to 2017 were included. A reference group was formed on a 1:3 basis and matched for age, sex, and diagnosis, consisting of 1118 conventional THAs. Implant survival estimates using death as a competing risk were assessed with revision for any reason and for any aseptic reason as the endpoints. The Cox multiple regression models were adjusted for age, sex, and diagnosis. The mean follow-up time was 3.3 (0-12.4) years for the constrained device group and 3.8 (0-12.0) years for the reference group. Results: Overall, there were 21 revisions in the constrained device group and 49 in the reference group. The 8-year survivorship for any reason was 94% (confidence interval [CI]: 91-96) for the constrained device group and 93% (CI: 89-97) for the reference group. With revision for any aseptic reason as the endpoint, the 8-year survivorships were 97% (CI: 95-99) and 94% (CI: 90-98), respectively. During the first 1.5 years, the constrained acetabular device group had a similar revision risk (hazard ratio: 1.09 [CI: 0.57-2.07], P = .8) to that of the reference group. Conclusion: The constrained acetabular device had good survival in primary THA, and our results support its continued use even in high-risk patients. (C) 2019 The Authors. Published by Elsevier Inc.Peer reviewe

Short-term survival of cementless Oxford unicondylar knee arthroplasty based on the Finnish Arthroplasty Register

Background: Cementless unicondylar knee arthroplasty (UKA) was introduced to secure longterm fixation and reduce the risk of revision. Experience with cementless UKA fixation is limited. Methods: The short-term survival (up to five years) of cementless Oxford UKA was assessed using data from the Finish Arthroplasty Register and was compared with that of cemented Oxford 3 UKA and total knee arthroplasty (TKA). Datawere obtained, from the Finnish Arthroplasty Register, on 1076 cementless Oxford UKAs and 2279 cemented Oxford 3 UKAs performed for primary osteoarthritis in 2005-2015. The Kaplan-Meier method, with revision for any reason as the endpoint, was used to assess the survival of these two UKA groups, and the results were compared with that of 65,563 cemented TKAs treated for primary osteoarthritis over the same period. The risk of revision of both Oxford prostheses was compared using Cox regression model, with adjustment for age and sex, with the cemented TKA group as reference. Results: The three-year survival was 93.7% for the cementless Oxford, 922% for the cemented Oxford 3, and 97.3% for the cemented TKA. The corresponding figures at five years were 92.3%, 88.9%, and 96.6%, respectively. The revision rate for both the cementless Oxford and the cemented Oxford 3 was significantly increased when compared with the cemented TKA (P <0.001). Conclusions: The survival of the cementless Oxford method was higher than that of the cemented Oxford 3 in the short term. The overall survival of Oxford UKA was poor in comparison with contemporary TKAs. (C) 2019 Elsevier B.V. All rights reserved.Peer reviewe

Implant Survival of Constrained Acetabular Device in Primary Total Hip Arthroplasty Based on Data From the Finnish Arthroplasty Register

Background: Constrained acetabular devices were developed to prevent dislocations after total hip arthroplasty (THA). However, the data on their success have been contradictory. In this study, we aimed to assess implant survival of the constrained acetabular device in primary THA based on the Finnish Arthroplasty Register data.Methods: A total of 373 primary THAs with constrained acetabular devices inserted from 2006 to 2017 were included. A reference group was formed on a 1:3 basis and matched for age, sex, and diagnosis, consisting of 1118 conventional THAs. Implant survival estimates using death as a competing risk were assessed with revision for any reason and for any aseptic reason as the endpoints. The Cox multiple regression models were adjusted for age, sex, and diagnosis. The mean follow-up time was 3.3 (0-12.4) years for the constrained device group and 3.8 (0-12.0) years for the reference group.Results: Overall, there were 21 revisions in the constrained device group and 49 in the reference group. The 8-year survivorship for any reason was 94% (confidence interval [CI]: 91-96) for the constrained device group and 93% (CI: 89-97) for the reference group. With revision for any aseptic reason as the endpoint, the 8-year survivorships were 97% (CI: 95-99) and 94% (CI: 90-98), respectively. During the first 1.5 years, the constrained acetabular device group had a similar revision risk (hazard ratio: 1.09 [CI: 0.57-2.07], P = .8) to that of the reference group.Conclusion: The constrained acetabular device had good survival in primary THA, and our results support its continued use even in high-risk patients

No difference in implant survival between 28-mm M2a RingLoc metal-on-metal and metal-on-polyethylene total hip arthroplasty : results from the Finnish Arthroplasty Register

Publisher Copyright: © 2022 The Author(s).Background and purpose — Long-term outcome of small head (28 mm) metal-on-metal (MoM) total hip arthroplasty (THA) is available mainly for Metasul devices (Sulzer Medica, Winterthur, Switzerland). Biomet MoM THA was frequently used in Finland. Therefore, we assessed long-term survivorship of the M2a 28-mm RingLoc MoM THA (Biomet, Warsaw, IN, USA) and compared it with the metal-on-polyethylene (MoP) RingLoc THA from the same manufacturer. Patients and methods — We conducted a register study based on THAs from the Finnish Arthroplasty Register performed between January 1, 2000 and December 31, 2007. 290 28-mm head M2a MoM THAs and 1,647 28-mm head MoP THAs (reference group) were included. The endpoint was revision for any reason, or revision for aseptic loosening, osteolysis, liner wear, or metallosis as one group. Kaplan– Meier survival estimates were calculated, and revision risks were assessed using a Cox multiple regression model, both with 95% confidence intervals (CI). Results — No difference was found in the 15-year Kaplan–Meier survivorship between the 28-mm head M2a RingLoc MoM THA and the reference group for any reason for revision (87.7% [82.9–92.1] and 83.3% [81.0–85.3], respectively). The adjusted hazard ratio (HR) for any reason for revision for the MoM THA group compared with the reference group was at least equal or better (0.70 [0.48–1.02]). Both groups presented similar survival for revision for aseptic loosening of the cup, osteolysis, liner wear, or metallosis, at 96.2% (92.7–98.0) and 95.4% (93.9–96.5), respectively. Interpretation — In the long-term survival there was no difference between the M2a 28-mm RingLoc MoM THA and 28-mm MoP THA. Further follow-up regimens for M2a 28-mm RingLoc THA patients may be unnecessary, but long-term metal ion and radiological data is needed before any formal suggestions.Peer reviewe

Implant survival of 2,723 vitamin E-infused highly crosslinked polyethylene liners in total hip arthroplasty: data from the Finnish Arthroplasty Register

Background and purpose - The use of crosslinked polyethylene in total hip arthroplasty (THA) has decreased wear remarkably. It has been suggested that the antioxidative effects of vitamin E may enhance the wear properties of polyethylene even further. This study evaluates revision rates between vitamin E-infused polyethylene liners (E1 and E-poly, ZimmerBiomet, Warsaw, IN, USA) versus moderately crosslinked polyethylene (ModXLPE) liners from the same manufacturer used in primary THA.Patients and methods - We conducted a study based on data from the Finnish Arthroplasty Register. The study group consisted of 2,723 THAs with a vitamin E-infused liner and a reference group of 2,707 THAs with a moderately crosslinked polyethylene liner. Survivorship, revision risk, and re-revision causes were compared between groups.Results - The 7-year survival of the vitamin E-infused polyethylene liner group and of the reference group with revision for any reason as the endpoint was comparable (94% [95% CI 92.9-94.9] and 93% [CI 91.9-93.9], respectively). The adjusted hazard ratio (HR) for any revision was similar between the groups (0.7 [CI 0.4-1.1]). When revision for aseptic loosening was studied as the endpoint, the survival for the study group was 99% (CI 98.6-99.4) and for the reference group 99% (CI 98.7-99.5), and the risk of revision was comparable between the study groups (HR 1.3 [CI 0.7-2.5]).Interpretation - After an observation period of 7 years vitamin E-infused liners shows results equal to results obtained with crosslinked polyethylene liners

Implant Survival of 6,080 Tritanium Cups in Primary Total Hip Arthroplasty Data from the Finnish Arthroplasty Register from 2009 to 2017

Background: To enhance osseointegration in total hip arthroplasty (THA), ultraporous or highly porous-coated cups were introduced. Implant survival data on these new devices have been scarce. The aim of our study was to assess the survivorship of ultraporous Tritanium cups (Stryker) in a population-based register study.Methods: In this study, we collected data on 6,080 primary THAs using a Tritanium cup and 25,670 THAs using a conventional cup (control group) from the Finnish Arthroplasty Register; these procedures were performed from January 1, 2009, to December 31, 2017. We calculated the Kaplan-Meier survival estimates with 95% confidence intervals (CIs). The end point was revision for any reason or for aseptic loosening of the cup. The revision risks were assessed with use of the Cox multiple regression model. The variables assessed in the Cox model were femoral head size, age group, involved side, operation year, sex, diagnosis, and fixation of the stem. The proportional hazards assumption of the Cox model was not fulfilled, so the follow-up time was divided into 3 time periods: 0 to 2 years, >2 to 4 years, and >4 years.Results: When comparing the 2 groups with regard to revision for any reason, the 5-year Kaplan-Meier survivorship of the Tritanium group (94.7% [95% CI, 94.0% to 95.4%]) was inferior to that of the control group (96.0% [95% CI, 95.7% to 96.3%]). In the Cox regression analysis of the 2 groups for the time period of >4 years, the Tritanium group had an increased risk of revision for any reason compared with the control group (hazard ratio [HR], 3.12 [95% CI, 1.82 to 5.35]; p 2 to 4 years (HR, 11.2 [95% CI, 3.28 to 38.0]; p Conclusions: There was no advantage to using the ultraporous-coated Tritanium cup for primary THA compared with conventional uncemented cups. However, wide CIs for some HR estimates may point to a lack of precision. Therefore, further research on subject is needed.</div

Risk factors for prosthetic joint infections following total hip arthroplasty based on 33,337 hips in the Finnish Arthroplasty Register from 2014 to 2018

Background and purpose - Periprosthetic joint infection (PJI) is a devastating complication and more information on risk factors for PJI is required to find measures to prevent infections. Therefore, we assessed risk factors for PJI after primary total hip arthroplasty (THA) in a large patient cohort. Patients and methods - We analyzed 33,337 primary THAs performed between May 2014 and January 2018 based on the Finnish Arthroplasty Register (FAR). Cox proportional hazards regression was used to estimate hazard ratios with 95% confidence intervals (CI) for first PJI revision operation using 25 potential patient- and surgical-related risk factors as covariates. Results - 350 primary THAs were revised for the first time due to PJI during the study period. The hazard ratios for PJI revision in multivariable analysis were 2.0 (CI 1.3-3.2) for ASA class II and 3.2 (2.0-5.1) for ASA class III-IV compared with ASA class I, 1.4 (1.1-1.7) for bleeding > 500 mL compared with 120 minutes compared with 45-59 minutes, and 2.6 (1.4-4.9) for simultaneous bilateral operation. In the univariable analysis, hazard ratios for PJI revision were 2.3 (1.7-3.3) for BMI of 31-35 and 5.0 (3.5-7.1) for BMI of > 35 compared with patients with BMI of 21-25. Interpretation - We found several modifiable risk factors associated with increased PJI revision risk after THA to which special attention should be paid preoperatively. In particular, high BMI may be an even more prominent risk factor for PJI than previously assessed.Peer reviewe

Short-term effects of a digital patient journey solution on patient-reported outcomes and health care utilization in arthroplasty : a pragmatic randomized controlled trial

Mobile health solutions for patient support have been proposed as promising and safe alternatives to usual care in adults undergoing primary total hip and knee arthroplasty. Studies of such applications, however, have produced conflicting results and only moderate- to low-quality evidence. This study aims to evaluate the short-term effects of a digital patient journey solution on patient-reported outcomes and health care utilization in patients undergoing total hip and knee arthroplasty using a pragmatic randomized controlled trial design. Randomly allocated patients in the control arm (n = 35, 64 ± 9 years) received usual care, while patients in the intervention arm (n = 34, 62 ± 11 years) received the digital patient journey solution in addition to usual care. The primary outcome was health-related quality of life as measured by the EuroQol EQ-5D-5L scale. Secondary outcomes included functional recovery, pain, self-efficacy, patient experience, adherence to fast-track protocol, and health care utilization. Participants were followed from a preoperative surgical visit until a postoperative follow-up visit at 6–12 weeks. The health-related quality of life, functional recovery, pain, patient experience, adherence to the fast-track protocol, and health care utilization did not differ between the arms. During the study, however, the self-efficacy to use digital health services (p=0.027) increased in the intervention arm. The use of the digital patient journey solution was not superior to usual care in terms of patient-reported outcomes and health care utilization. However, the solution improved the self-efficacy of patients to use digital health services, which may lead to greater demand for similar digital offerings as patient become more familiar with mobile health solutions.Peer reviewe