Development of a New Patient Reported Outcome Measure (PROM) to Assess Patient's Emotional Wellbeing, and Perceptions of Total Knee Replacement Surgery for the Treatment of Knee Arthritis Phase Four - Validation of Final Questionnaire This Phase is to Validate the Final Questionnaire in Terms of Reliability, Validity and Ability to Detect Change

Development of a new Patient Reported Outcome Measure (PROM) to assess patient's emotional wellbeing, and perceptions of Total Knee Replacement surgery for the treatment of knee arthritis.

开始日期2024-10-01

申办/合作机构

Invibio Ltd.

[+1]

NCT05692687 / RecruitingN/A

A Prospective, Non-comparative, Multi-centre, Post-market Clinical Study to Evaluate the Safety and Performance of the Carbon Fibre Reinforced Polyetheretherketone Metatarso-Phalangeal (MTP) Plate (CoLink® PCR MTP Plate) for the Treatment of Hallux Rigidus

The clinical study involves the routine treatment of skeletally mature patients who have been diagnosed with hallux rigidus (stiffness of the first metatarso-phalangeal joint in the foot due to arthritis and degeneration of cartilage).
It follows standard practice surgery to treat this condition. This type of degenerative arthritis affects the joint of the big toe (hallux) which is attached to the foot. Taking part in this research will involve collecting data of the surgery to remove damaged cartilage and fix the two bones together with screws and a plate (called the CoLink® PCR MTP Plate).

开始日期2023-03-15

申办/合作机构

Invibio Ltd.

[+1]

NCT05631392 / RecruitingN/A

A Prospective, Non-randomised, Multi-centre, Post-market Clinical Follow-up Observational Study to Evaluate the Clinical and Radiographic Outcomes of the BEE® HA Cage for Anterior Cervical Discectomy and Fusion.

Observational data collection of information after undergoing standard Cervical spine fusion surgery.

开始日期2023-02-03

申办/合作机构

Invibio Ltd.

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0 项与 Invibio Ltd. 相关的专利（医药）

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2023-12-01·Medical engineering & physics

The sensitivity of the stiffness and thickness of a titanium inlay in a cementless PEEK femoral component to the micromotions and bone strain energy density

Article

作者: Post, Corine E ; Janssen, Dennis ; Verdonschot, Nico ; Bitter, Thom ; Briscoe, Adam

Polyetheretherketone (PEEK) has been proposed as alternative material for total knee arthroplasty implants due to its low stiffness, which may reduce stress-shielding. In cementless fixation, a proper primary fixation is required for long-term fixation. Previous research showed that the lower stiffness of a cementless PEEK femoral component results in larger micromotions at the implant-bone interface compared to a cobalt-chrome femoral component. A titanium inlay on the PEEK implant surface may improve the primary fixation while maintaining the favourable stiffness properties. Therefore, the effect of thickness and stiffness of a titanium inlay on the primary fixation and stress-shielding was investigated. A finite element model of the femur and femoral component was created with five titanium inlay variants. The micromotions and strain energy density (SED) were quantified as outcome measures. The distal thin - proximal thick variant showed the largest resulting micromotions (51.2 µm). Relative to the all-PEEK femoral component, the addition of a titanium inlay reduced the micromotions with 30 % to 40 % without considerably affecting the stress-shielding capacity (strain energy difference of 6 % to 10 %). Differences in micromotions (43.0-51.2 µm) and SED between the variants were relatively small. In conclusion, the addition of a titanium inlay could lead to a reduction of the micromotions without substantially affecting the SED distribution.

2021-03-01·Journal of biomechanics2区 · 工程技术

Decreased stress shielding with a PEEK femoral total knee prosthesis measured in validated computational models

2区 · 工程技术

Article

作者: Janssen, Dennis ; Verdonschot, Nico ; Browne, Martin ; Briscoe, Adam ; Rankin, Kathryn ; de Ruiter, Lennert

Due to their high stiffness, metal femoral implants in total knee arthroplasty may cause stress shielding of the peri-prosthetic bone, which can lead to loss of bone stock. Using a polymer (PEEK) femoral implant reduces the stiffness mismatch between implant and bone, and therefore has the potential to decrease strain shielding. The goal of the current study was to evaluate this potential benefit of PEEK femoral components in cadaveric experiments. Cadaveric femurs were loaded in a materials testing device, while a 3-D digital image correlation set-up captured strains on the surface of the intact femurs and femurs implanted with PEEK and CoCr components. These experimental results were used to validate specimen-specific finite element models, which subsequently were used to assess the effect of metal and PEEK femoral components on the bone strain energy density. The finite element models showed strain maps that were highly comparable to the experimental measurements. The PEEK implant increased strain energy density, relative to the preoperative bone and compared to CoCr. This was most pronounced in the regions directly under the implant and near load contact sites. These data confirm the hypothesis that a PEEK femoral implant can reduce peri-prosthetic stress shielding.

2019-05-01·Medical engineering & physics3区 · 工程技术

Finite element investigation into the use of carbon fibre reinforced PEEK laminated composites for distal radius fracture fixation implants

3区 · 工程技术

Article

作者: Lamorinière, Steven ; Gallagher, Elizabeth Anne ; McGarry, Patrick

Carbon fibre reinforced PEEK (CF/PEEK) laminates provide mechanical advantages over homogenous metal osteo-synthesis implants, e.g. radiolucency, fatigue strength and strength to weight ratio. Implants can be designed with custom anisotropic material properties, thus enabling the engineer to tailor the overall stiffness of the implant to the specific loading conditions it will experience in vivo. In the current study a multi-scale computational investigation of idealised distal radius fracture fixation plate (DRP) is conducted. Physiological loading conditions are applied to macro-scale finite element models of DRPs. The mechanical response is compared for several CF/PEEK laminate layups to examine the effect of ply layup design. The importance of ply orientation in laminated DRPs is highlighted. A high number of 0° plies near the outer surfaces results in a greater bending strength while the addition of 45° plies increases the torsional strength of the laminates. Intra-laminar transverse tensile failure is predicted as the primary mode of failure. A micro-mechanical analysis of the CF/PEEK microstructure uncovers the precise mechanism under-lying intra-laminar transverse tensile crack to be debonding of the PEEK matrix from carbon fibres. Plastic strains in the matrix material are not sufficiently high to result in ductile failure of the matrix. The findings of this study demonstrate the significant challenge in the design and optimisation of fibre reinforced laminated composites for orthopaedic applications, highlighting the importance of multi-scale modelling for identification of failure mechanisms.

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2024-10-31

·Medical Plastics News

Nvision Biomedical 3D-printed PEEK Interbody System receives FDA clearance

Nvision Biomedical Technologies and Invibio Biomaterial Solutions have announced that the FDA has granted clearance of the first 3D-Printed PEEK Interbody System made from PEEK-OPTIMA. The 3D-Printed PEEK Interbody System from Nvision Biomedical Technologies was co-developed with Invibio Biomaterial Solutions. The system consists of Cervical and Anterior Lumbar Interbody Fusion (ALIF) spine devices, each incorporating extensive porous structures that have the potential to promote multi-directional bone ingrowth and improve device fixation, whilst also maintaining PEEK-OPTIMA’s inherent benefits in modulus and imaging. The use of PEEK-OPTIMA - a material that has already been used in over 15 million implants - offers the benefits of mechanical properties closer to those of bone and also superior imaging capability than titanium implants, the latter allowing surgeons to more accurately monitor fusion progression. Nvision’s 3D-Printed PEEK Interbody System is a standout in the field of spinal devices as it is the first to combine PEEK-OPTIMA with the design freedom enabled by the Bond3D additive manufacturing technology to print solid and porous areas for bone ingrowth.

2024-02-20

·Business Wire

Global Medical Plastics Strategic Research Report 2024: Market to Surpass $50 Billion by 2030 - Advancements in Medical Plastics and Production Capabilities Drive Innovative Applications - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Medical Plastics - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering. Global Medical Plastics Market to Reach $50.5 Billion by 2030 The global market for Medical Plastics estimated at US$31 Billion in the year 2022, is projected to reach a revised size of US$50.5 Billion by 2030, growing at a CAGR of 6.3% over the analysis period 2022-2030. Engineering Plastics, one of the segments analyzed in the report, is projected to record a 9.1% CAGR and reach US$6.3 Billion by the end of the analysis period. Growth in the High Performance Plastics (hpp) segment is estimated at 7.6% CAGR for the next 8-year period. The U.S. Market is Estimated at $8.2 Billion, While China is Forecast to Grow at 7.8% CAGR The Medical Plastics market in the U.S. is estimated at US$8.2 Billion in the year 2022. China, the world's second largest economy, is forecast to reach a projected market size of US$8.2 Billion by the year 2030 trailing a CAGR of 7.8% over the analysis period 2022 to 2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 5% and 5.4% respectively over the 2022-2030 period. Within Europe, Germany is forecast to grow at approximately 5.9% CAGR. Led by countries such as Australia, India, and South Korea, the market in Asia-Pacific is forecast to reach US$5.1 Billion by the year 2030. What`s New? Special discussions on the global economic climate and market sentiment Coverage on global competitiveness and key competitor percentage market shares Market presence analysis across multiple geographies - Strong/Active/Niche/Trivial Online interactive peer-to-peer collaborative bespoke updates Access to digital archives and research platform Complimentary updates for one year Access to curated YouTube video transcripts of market sentiments shared by CEOs, domain experts and market influencers via interviews, podcasts, press statements and event keynotes Key Attributes: Report Attribute Details No. of Pages 604 Forecast Period 2022 - 2030 Estimated Market Value (USD) in 2022 $31 Billion Forecasted Market Value (USD) by 2030 $50.5 Billion Compound Annual Growth Rate 6.3% Regions Covered Global MARKET OVERVIEW Plastics in Healthcare: Pioneering New Frontiers in Medical Device Evolution Trends Shaping the Medical Devices and Medical Plastics Industries Medical Plastics - A SWOT Analysis Global Economic Update COVID-19 Revives Interest in Plastics for Medical Industry Competitive Market Presence - Strong/Active/Niche/Trivial for 97 Players Worldwide in 2023 (E) Plastics Used in Medical Devices Types of Medical Plastics Recent Market Activity MARKET TRENDS & DRIVERS Bioplastics in the Medical Sector: A Sustainable Innovation Gaining Interest Growing Applications of Bioresorbable and Biodegradable Polymers Biodegradable Polymers in Nano Drugs: A Growing Market Rise in Importance of 3D Printing in Manufacturing of Medical Devices Multi-Jet Fusion Technology: Revolutionizing Medical 3D Printing PEEK Emerges as a Key Material for 3D Printing Medical Devices Micro-Moulding Medical Plastics, an Essential Manufacturing Technique for Implants and other Medical Devices Silicone Gains Increased Acceptance in Medical Applications Growing Prominence of Silicone in Surgical and Medical Device Bonding Drive Demand in Medical Applications Wearable Medical Devices: A Lucrative End-use Market for Medical Silicone Silicone Elastomers Gain Attractive Penetration in Medical & Healthcare Industry Growing Adoption of Medical Robots Creates Demand for High Strength Plastics Advancements in Medical Plastics and Production Capabilities Drive Innovative Applications Growing Demand for Point of care Diagnostics Drive Gains Plastics Aid Artificial Organs Revolutionize Medical Industry Engineered Resins Continue to Evolve PEEK Polymers Gain Importance in Orthopedic Implants Thermoplastic Elastomers Find Growing Use in Medical Industry Rising Popularity of TPEs for Medical Tubing Applications Antimicrobial Plastics for Medical Devices Gain Prominence Trends in Decorating Techniques Used in Medical Device Manufacture Disposables Widen Demand for Advanced Polymers Medical Device Packaging: A Pivotal Aspect of Modern Healthcare System Sterilization Techniques Play a Vital Role in Selection of Polymers for Medical Applications Sustainable Healing: Pioneering the Recycling Revolution in Medical Plastics Rise in Healthcare Expenditure to Drive Growth Demographic Trends Push the Market Ahead FOCUS ON SELECT PLAYERS (Total 97 Featured) BASF SE Lanxess AG Eastman Chemical Company Kuraray Co., Ltd. Exxon Mobil Corporation Covestro AG Chi Mei Corporation AdvanSource Biomaterials Corporation Invibio Ltd. Addiplast SA Engineered Polymers (India) Pvt., Ltd. Distrupol Ltd. Elix Polymers SLU Kraton Corporation GW Plastics, Inc. For more information about this report visit https://www.researchandmarkets.com/r/kq5v44 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

2024-02-19

·PRNewswire

Global Medical Plastics Strategic Research Report 2024-2030 - Pioneering New Frontiers in Medical Device Evolution

DUBLIN, Feb. 19, 2024 /PRNewswire/ -- The "Medical Plastics - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering. Global Medical Plastics Market to Reach $50.5 Billion by 2030 The global market for Medical Plastics estimated at US$31 Billion in the year 2022, is projected to reach a revised size of US$50.5 Billion by 2030, growing at a CAGR of 6.3% over the analysis period 2022-2030. Engineering Plastics, one of the segments analyzed in the report, is projected to record a 9.1% CAGR and reach US$6.3 Billion by the end of the analysis period. Growth in the High Performance Plastics (hpp) segment is estimated at 7.6% CAGR for the next 8-year period. The U.S. Market is Estimated at $8.2 Billion, While China is Forecast to Grow at 7.8% CAGR The Medical Plastics market in the U.S. is estimated at US$8.2 Billion in the year 2022. China, the world's second largest economy, is forecast to reach a projected market size of US$8.2 Billion by the year 2030 trailing a CAGR of 7.8% over the analysis period 2022 to 2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 5% and 5.4% respectively over the 2022-2030 period. Within Europe, Germany is forecast to grow at approximately 5.9% CAGR. Led by countries such as Australia, India, and South Korea, the market in Asia-Pacific is forecast to reach US$5.1 Billion by the year 2030. What`s New? Special discussions on the global economic climate and market sentiment Coverage on global competitiveness and key competitor percentage market shares Market presence analysis across multiple geographies - Strong/Active/Niche/Trivial Online interactive peer-to-peer collaborative bespoke updates Access to digital archives and research platform Complimentary updates for one year Access to curated YouTube video transcripts of market sentiments shared by CEOs, domain experts and market influencers via interviews, podcasts, press statements and event keynotes MARKET OVERVIEW Plastics in Healthcare: Pioneering New Frontiers in Medical Device Evolution Trends Shaping the Medical Devices and Medical Plastics Industries Medical Plastics - A SWOT Analysis Global Economic Update COVID-19 Revives Interest in Plastics for Medical Industry Competitive Market Presence - Strong/Active/Niche/Trivial for 97 Players Worldwide in 2023 (E) Plastics Used in Medical Devices Types of Medical Plastics Recent Market Activity MARKET TRENDS & DRIVERS Bioplastics in the Medical Sector: A Sustainable Innovation Gaining Interest Growing Applications of Bioresorbable and Biodegradable Polymers Biodegradable Polymers in Nano Drugs: A Growing Market Rise in Importance of 3D Printing in Manufacturing of Medical Devices Multi-Jet Fusion Technology: Revolutionizing Medical 3D Printing PEEK Emerges as a Key Material for 3D Printing Medical Devices Micro-Moulding Medical Plastics, an Essential Manufacturing Technique for Implants and other Medical Devices Silicone Gains Increased Acceptance in Medical Applications Growing Prominence of Silicone in Surgical and Medical Device Bonding Drive Demand in Medical Applications Wearable Medical Devices: A Lucrative End-use Market for Medical Silicone Silicone Elastomers Gain Attractive Penetration in Medical & Healthcare Industry Growing Adoption of Medical Robots Creates Demand for High Strength Plastics Advancements in Medical Plastics and Production Capabilities Drive Innovative Applications Growing Demand for Point of care Diagnostics Drive Gains Plastics Aid Artificial Organs Revolutionize Medical Industry Engineered Resins Continue to Evolve PEEK Polymers Gain Importance in Orthopedic Implants Thermoplastic Elastomers Find Growing Use in Medical Industry Rising Popularity of TPEs for Medical Tubing Applications Antimicrobial Plastics for Medical Devices Gain Prominence Trends in Decorating Techniques Used in Medical Device Manufacture Disposables Widen Demand for Advanced Polymers Medical Device Packaging: A Pivotal Aspect of Modern Healthcare System Sterilization Techniques Play a Vital Role in Selection of Polymers for Medical Applications Sustainable Healing: Pioneering the Recycling Revolution in Medical Plastics Rise in Healthcare Expenditure to Drive Growth Demographic Trends Push the Market Ahead FOCUS ON SELECT PLAYERS (Total 97 Featured) BASF SE Lanxess AG Eastman Chemical Company Kuraray Co., Ltd. Exxon Mobil Corporation Covestro AG Chi Mei Corporation AdvanSource Biomaterials Corporation Invibio Ltd. Addiplast SA Engineered Polymers (India) Pvt., Ltd. Distrupol Ltd. Elix Polymers SLU Kraton Corporation GW Plastics, Inc. For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

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