rex cement mixer

FROM CONCEPT
TO PRODUCT.
RESEARCH, DEVELOPMENT, MANUFACTURING, TESTING & CLINICAL EVALUATION
Project examples
Joined Orthopaedic Innovators Netherlands
Spierings Medische Techniek B.V.
Spierings Medische Techniek is a medical product development company with a strong focus on engineering and development
services for third parties and has vast experience in developing implants and instruments for all major orthopaedic marketing
companies. Spierings Medische Techniek has developed several hip and knee implants, works according to the MDD 93/42 and is
ISO 13485:2003 certified.
Spierings Medische Techniek has studied, designed and created a large number of orthopaedic devices for reconstructive and
trauma surgery. Throughout the years and in numerous projects Spierings gathered specific knowledge of and experience with
developing, producing and testing a high variety of surgical implants and instruments, including hip, knee, wrist and finger prostheses, trauma devices, revision instruments, bone grafting instrumentation, biodegradable cement stops, bone cements, vacuum
mixing systems and bone lavage systems.
The quality of the products of Spierings Medische Techniek originates from their extensive knowledge of orthopaedic surgery and
frequent contact with users. With extensive medical and technical knowledge and experience in the orthopaedic market, Spierings’ products are tailored to suit the needs of patients and surgeons.
Project examples
Symax™ Total Hip System
The Symax™ Stem has an anatomic design. Its proximal interference fit, based on anatomical
geometry analysis studies, results in a more natural proximal stress distribution and less stress
shielding. The Symax™ Stem has a reduced neck diameter, a short taper (V40™) and a small
CCD angle (128°) to extend the range of motion. Its natural anatomy dictates progressive
anteversion with increasing size. An implant size independent constant leg length is assured.
The instrumentation gives better accuracy in preparation together with optimal canal filling.
REX Cement Stop™ System
The REX Cement Stop™ seals efficiently round, non-round and irregularly shaped intramedullary canals and can resist high cement pressure without migration. It comprises a serrated
pin, a washer, a locking ring and an expandable gelatine bushing. By using an insertion instrument, the gelatine bushing expands under axial compression. It fully adapts to the intramedullary canal geometry and gets fixated in the intramedullary canal. The serrated pin,
washer and locking ring will chemically bond to the polymerising cement mantle, while the
gelatine bushing fully resorbs within 4 weeks.
Development & testing of bone cement
Spierings has extensive knowledge and many years of experience in the testing and development of acrylic bone cement and bone cement accessories. A number of standardized tests
as well as specific test protocols developed to compare and characterize bone cements and
their mixing systems are performed in house. These include static and dynamic mechanical,
rheological, structural and thermal tests. Tests for handling properties at different ambient
temperatures are conducted in a temperature and humidity controlled room.
Patella In Place Knee Balancer
The Patella In Place Knee Balancer is designed to prepare the distal femur for placement of a
femoral component of Stryker’s Scorpio or Triathlon knee prosthesis in total knee arthroplasty. The set of tools enables ligament balancing to be carried out with the patella in place, thereby taking the patella tendon tension into account for an optimal ligament balancing result.
Orthopaedic Research Lab
The Orthopaedic Research Laboratory (ORL) is specialized in laboratory tests and computer simulations to evaluate orthopaedic
implants. The ORL is well equipped to perform mechanical tests, cadaver testing, in vivo animal testing and complex finite element
analyses. It has its own histology and cell culture facilities and has ample experience with various animal models.
The ORL performs fundamental and applied research in the field of orthopaedics. We specialize in mechanical testing, computational analyses, histological analyses and animal testing. The strength of the ORL lies in combining these techniques, allowing for
cross-validation and innovative research.
The ORL is part of the Radboud University Nijmegen Medical Centre. The lab is run by biologist prof. Pieter Buma, PhD and biomechanical engineer prof. Nico Verdonschot, PhD. The ORL is a multidisciplinary group with personnel with biological, engineering,
movement sciences and clinical backgrounds.
For in vivo testing of orthopaedic devices or procedures the ORL has access to the Central Animal Laboratory of the Radboud University Nijmegen Medical Centre. The animal laboratory offers expertise and facilities, such as medical imaging, to support animal
testing for orthopaedic applications.
Project examples
High flexion Total Knee Arthroplasty
High-flexion knee arthroplasty has been developed to accommodate a large range of motion
(flexion > 120°). Knee implants that allow for higher flexion may be more sensitive to femoral
loosening, as the knee load is relatively high during deep knee flexion. In this project, a 3D
finite element knee model was developed to analyze loosening of the implant-cement interface during squatting.
Optimization cementless femoral hip implants
We have developed an FEA-based algorithm to simulate interfacial micromotions, which enables us to evaluate the effect of various design parameters on the long-term stability of cement femoral stems. In addition to this, we evaluated how these design features affect bone
remodeling, which is a second factor involved in the long-term performance of cementless
stems. Using these two methods, we were able to find an optimized implant composition,
which was stiff enough to limit micromotions, but compliant enough to prevent adverse
bone remodeling.
Meniscus implant
The meniscus is a flexible disc of cartilage in the knee joint that serves as a ‘shock absorber’.
However, the meniscus is sensitive to tears, for example, due to a sport injury or old age. In
most cases, it is not possible to recover from such tears. Damage to the meniscus may eventually result in osteoarthritis, causing pain in the knee joint. Together with other partners we
designed a new artificial meniscus made from very strong, flexible and durable synthetics.
The implant design is being evaluated through pre-clinical mechanical, biological and animal
testing.
Patella tracking
It is often suggested that patella tracking after total knee arthroplasty with an asymmetrical patella groove is more physiological than with a symmetrical patella groove. This project
investigated the effect of TKA on patella tracking. The patellar and tibial kinematics were investigated in cadaveric knee specimens, using an electromagnetic motion tracking system,
during flexion movement of the knee. This study indicated that conventional TKA significantly changes physiological patello-femoral kinematics.
Anatomy
The department of Anatomy provides human material for scientific education and research purposes, and has well equipped skills
labs with expert teaching assistance. The department of Anatomy is part of the Radboud University Nijmegen Medical Centre.
The department of Anatomy is well equipped to assist you with your cadaver simulation implantations and surgical training. In
its skills laboratory implant prototypes can be evaluated and realistic cadaver simulation implantations can be performed in replicated operating room conditions. The department of Anatomy has organized many national and international courses for both
trauma and orthopaedic surgeons in which damage control procedures and surgical techniques were being practiced on cadavers.
In addition, the department of Anatomy has partnered the Orthopaedic Research Lab and numerous orthopaedic companies with
the evaluation of the biomechanical aspects of many different orthopaedic implants in human cadaver material. The department
of Anatomy participates in many educational programs for medical students, residents and specialists.
Project examples
Simulation implantations
Initial evaluation of many implant prototypes has been performed in the skills laboratory of
the department of Anatomy. With progressing development, the cadaver simulation implantations become increasingly more realistic in replicating operating room conditions, up to full
OR mock-ups. The goal of the cadaver trials is to validate the various system components in
terms of robustness, usability, safety and accuracy. Cadaver trials can be extremely helpful in
the later design of clinical procedures and protocols.
Definitive Surgical Trauma Care® course
The Definitive Surgical Trauma Care® Course is an international course for trauma surgeons.
Damage control procedures are practiced on cadavers. The course is designed for surgeons
who may not have immediate access to sophisticated facilities and those working in emergency or surgical departments who have to treat victims of major trauma. Practical training of
surgical skills, such as exposure neck, chest and abdomen, and orthopaedic damage control
on fresh frozen human cadaver material is an important part of the program.
‘Wrist-Hand’ - Trauma course
This course focusses on the surgical treatment of hand and wrist trauma and is aimed at trainees in trauma and orthopaedics who want to gain further experience in hand and wrist
surgery. Special attention is paid to the anatomy of hand and wrist in relation to specific surgical techniques. The course emphasised hands-on cadaver training. The skills laboratory is
well equipped, with the entire inventory needed for dissection and bony fixation, including a
mini C-arm, allowing to check fixations. The implant company sponsoring the course has representatives on hand to inform candidates on the design and utility of the various implants.
Research & Education
Together with the Orthopaedic Research Lab and numerous orthopaedic companies the biomechanical aspects of many different orthopaedic implants have been tested and evaluated
in human cadaver material. In addition, the department of Anatomy participates in many
educational programs for medical students, residents & specialists.
Sint Maartenskliniek
The Sint Maartenskliniek is the only hospital in the Netherlands that is fully dedicated to the musculo-skeletal system and with 17
orthopaedic surgeons the largest orthopaedic hospital in the Netherlands. It conducts insightful and applied research aimed at
improving patient care. The Sint Maartenskliniek is ISO 9001:2008 and ISO/DIS 14155:2008 certified.
The Sint Maartenskliniek is a hospital that specializes in posture and movement, and the control of these. It has three basic specialities: orthopaedics, rheumatology and rehabilitation techniques. There are over 300 beds, 400 places for outpatient treatment and
an extensive outpatients’ clinic.
The clinic has its own department for scientific research. The hospital has a long-standing tradition in fundamental as well as clinical research in orthopedic surgery, rehabilitation medicine, rheumatology and associated disciplines. The Research institute of the
Sint Maartenskliniek supports the quest for evidence and practice-based medicine in all disciplines of the hospital. At the Research
institute, scientists work in close collaboration with specialists of the clinical departments and staff members assigned to quality
issues to form multidisciplinary groups. The focus is on improving the evidence base of interventions.
In its field, the Sint Maartenskliniek is therefore among the leading institutions in the Netherlands and in Europe. Because of the
expertise available to it, the hospital also fulfils the role of a training center.
Project examples
Mobile versus fixed bearing TKA
In this randomized controlled trial functional performance of patients with a fixed and mobile bearing total knee arthroplasty was compared. Outcome parameters active and passive
flexion, and the Knee Society Score were independently assessed until 2 years of follow-up.
Both bearings performed equally, except for stair climbing where the patients with a fixed
bearing showed better results.
Weight bearing after tibial osteotomy
In this prospective cohort study, we measured stability and possible loss of correction in
open-wedge osteotomy in patients following an early full weight bearing protocol and compared the results to those from a historical cohort of open-wedge osteotomy patients who
followed a standard protocol (full weight bearing after 6 weeks) using radiostereometry. The
Tomofix-plate-fixated open-wedge high tibial osteotomy allows early full weight bearing without loss of correction, which is of great benefit to our patients, and provides efficacy data for
the manufacturer of the implant.
Revision total knee replacement
A consecutive patient series undergoing revision total knee arthroplasty is monitored in the
largest database in Europe, hosted in the Sint Maartenskliniek. We evaluate outcome for the
different indications for revision total knee arthroplasty. By this cohort research we learn from
our experiences in order to improve the indication setting and outcomes of surgery, and to
inform and counsel patients better.
Effect of scoliosis surgery
In the movement analysis laboratory we evaluate gait and postural balance before and after
spinal fusion surgery in adolescent idiopathic scoliosis. With the help of demanding tasks
such as fast walking and uphill walking we assessed the functional outcome after spinal fusion surgery and try to highlight possible compensatory strategies.
European Medical Contract Manufacturing (EMCM) B.V.
EMCM is the center of excellence in developing, manufacturing and processing of sterile medical devices, medicinal products &
tissues for the orthopaedic market. EMCM possesses licences for the design, development, manufacturing and distribution of
Medical Devices (ISO 13485) and Human Tissue and a GMP licence for the manufacturing of Pharmaceuticals and is FDA approved.
Since its inception in 1993, EMCM has grown to a centre of excellence in the manufacturing and distribution of specialty products
in the fields of Biomaterials, Pharmaceuticals, Nutraceuticals & Tissue Engineering Constructs. Our focus lies on those products
which have unique qualities, serve niche markets and where the skills and expertise of our organisation can make a difference to
the lives of millions tomorrow.
As a part of aap Implantate AG, a company listed on the Frankfurt Stock Exchange, EMCM has grown from a start-up to a mid-sized
company that employs over 60 FTE and operates in over 1500 m2 of GMP accredited classified areas (clean rooms), conforming to
ISO & GMP standards for compliant manufacturing of medical products.
Using such qualified facilities EMCM produces a broad range of medical products offering complete custom made service and product packages: from product development, through regulatory affairs, purchasing, manufacturing, final packaging, warehousing
and distribution in the capacity of a contract manufacturer.
Project examples
Bone substitutes with novel controlled drug release technology
One of our customers have designed a novel drug release technology, which allows a controlled antibiotic release over a defined period of time. The designed product is a combination of
a polymer with a lipid-based reservoir system. This specific product is designed for bone void
filling and is used as an advanced bone substitute due to the long-lasting antibiotic release.
EMCM has aligned the manufacturing process into a fully classified GMP process. Ongoing activities include the scale-up of the manufacturing with respect to the critical manufacturing
parameters as well as the quality guidelines.
Liquids & suspensions for orthopaedic applications
EMCM has implemented an FDA compliant ampoule filling manufacturing process. The project is a finish-fill project for a US based company. The to-be handled bulk is a volatile liquid.
Due to EMCMs experience in the handling of volatile liquids we have been able to adapt
this into a safe process in our qualified production areas. To implement the manufacturing
we have carried out a pilot batch and this is subsequently transferred into a GMP batch. The
scope of the project also includes the validation of analytical test methods that are required
for the release of the product.
Development, upscale and tech-transfer of recombinant products
EMCM is working on a technology transfer project for another global company. A recombinant protein has been designed by the customer which will be applied in the dental field.
The product has been developed on a R&D scale and includes multiple critical steps during
its manufacturing such as freeze-drying, crosslinking reactions and sterilization. Therefore
EMCM has aligned the manufacturing of the product in an early-stage in order to maintain all
product properties. The production process will be translated in an up-scaled process as well
validation into our qualified cleanrooms and handling procedures.
Xenografts for dental & orthopedic applications
EMCM has developed a dental membrane for one of the global leaders in the dental market.
The membrane functions as a barrier between soft and hard tissue. The product is derived
from an animal source and is processed into a decellularized as well as delipidized sterile
product for dental application. EMCM has incorporated a novel approach for cleaning and
sterilization of this membrane which involves supercritical carbon dioxide. Currently, the manufacturing process is brought to a higher level by the transfer from a feasibility run to a
validated manufacturing process.
Bactimm B.V.
Bactimm has extensive experience with testing and validation of medical devices and offers a complete range of microbiological
and chemical analyses. Bactimm is an ISO 9001:2008, ISO 13485:2003, GMP-GCLP, and OECD-GLP certified company.
In 1996 Bactimm started as a production control laboratory for a manufacturer of sterile implantable medical devices Fame Holding. By acquiring Farmalyse in 2002, with more than 35 years experience in pharmaceutical chemical analyses, the companies extended the portfolio and developed into an internationally focussed contract laboratory. As of December 2012, Bactimm became
part of Sinensis Life Sciences. Sinensis Life Sciences is a group of laboratories dedicated to microbiology, analytical chemistry, and
biosafety testing. Sinensis is the parent company of Bactimm, PROXY Laboratories, Microsafe Laboratories, Farmalyse and Prolepha.
Bactimm is your partner for medical device analytical services. We combine medical device product knowledge with quality control testing, method development and validation studies. Reliable and fast throughput times together with high quality analytical
services are key elements of our organization. Bactimm has extensive experience with testing and validation of medical devices.
With our state-of-the-art laboratories we offer a complete range of services including chromatography facilities (HPLC, UPLC, GC,
LC-MS and TLC), spectroscopy (UV and IR) and GMP class A-D clean rooms. Bactimm is your partner for analytical services, laboratory investigations & international services that are customised to the requirements of the industry.
Project examples
Validation of aseptic media fills
According to (international) guidelines, invasive medical devices and/or preparations that
cannot be sterilized by means of heat, ETO or irradiation have to be manufactured under
aseptic conditions. To validate these aseptic conditions, under practical concitions, aseptic
mediafills are performed. These studies, executed as per ISO 113408 and EU-GMP guidelines
have been designed and tested for by Bactimm B.V.
Sterilization validation of coritcal bone grafts
Validation of a gamma irradiation sterilization cycle as per ISO 11137-2. Based on the VDmax25
approach, a sterilization dose of not less than 25 kGy was proven to result in a sterile production batch cortical bone scaffolds (SAL 10-6). The method uses the product’s natural bioburden
to assess the validaty of the sterilization program.
Evaluation of sporicidal activity after bone processing
Bone fragments have been spiked with spores of Bacillus megaterium to achieve a spore concentration of approximately 106 spores/fragment. After inoculation, the fragments were processed using different scCO2 based procedures. Subsequently, the treated fragments were
tested onto sterility as per PhEur 2.6.1 and ISO 11737-2 using direct immersion techniques.
Analytical methods for bone cement powder
The physicochemical characterization of PMMA bone cements have been studied in order to
monitor and guarantee the consistency and quality of cement production. We analyzed the
particle size distribution to describe the flow behavior of the cement and to gain insight into
the reaction velocity during curing of the cement product. Particle size measurements were
performed using laser diffraction. The amount of drugs entrapped in the cement can be analyzed using Ultra Performance Liquid Chromatography. By-products (acrylates) from cement
synthesis can be quantified using gas chromatography.
FROM CONCEPT TO PRODUCT.
Joined Orthopaedic Innovators Netherlands (JOINt) is a group of knowledgeable,
experienced orthopaedic partners from Nijmegen, the Netherlands with a proven
track record who work together as a cross-functional team, and provide a unique
single source solution to orthopaedic medical device companies and tissue banks.
Throughout the years and in numerous projects we have gathered specific knowledge of and experience with developing, producing and testing a high variety of
orthopaedic implants & instruments.
JOINt offers high value innovative services. Our capabilities cover the complete
spectrum of the product lifecycle from concept to product.
Contact information
Joined Orthopaedic Innovators Netherlands
Madoerastraat 24
6524 LH Nijmegen
The Netherlands
+31 (0)6 28 22 56 57
[email protected]
www.jointortho.org