Free-floating medial meniscus implant kinematics do not change after simulation of medial open-wedge high tibial osteotomy and notchplasty.

PURPOSE: The purpose of this in-vitro study was to examine the kinematics of an artificial, free-floating medial meniscus replacement device under dynamic loading situations and different knee joint states. METHODS: A dynamic knee simulator was used to perform dynamic loading exercises on three neutrally aligned and three 10° valgus aligned (simulating a medial openwedge high tibial osteotomy - MOWHTO) left human cadaveric knee joints. The knee joints were tested in three states (intact, conventional notchplasty, extended notchplasty) while 11 randomised exercises were simulated (jump landing, squatting, tibial rotation and axial ground impacts at 10°, 30° and 60° knee joint flexion) to investigate the knee joint and implant kinematics by means of rigidly attached reflective marker sets and an according motion analysis. RESULTS: The maximum implant translation relative to the tibial plateau was < 13 mm and the maximum implant rotation was < 19° for all exercises. Both, the notchplasties and the valgus knee alignment did not affect the device kinematics. CONCLUSIONS: The results of the present in-vitro study showed that the non-anchored free-floating device remains within the medial knee joint gap under challenging dynamic loading situations without indicating any luxation tendencies. This also provides initial benchtop evidence that the device offers suitable stability and kinematic behaviour to be considered a potential alternative to meniscus allograft transplantation in combination with an MOWHTO, potentially expanding the patient collective in the future.

Effects of a novel medial meniscus implant on the knee compartments: imaging and biomechanical aspects.

The altered biomechanical function of the knee following partial meniscectomy results in ongoing articular cartilage overload, which may lead to progressive osteoarthritis (OA). An artificial medial meniscus implant (NUsurface® Meniscus Implant, Active Implants LLC., Memphis, TN, USA) was developed to mimic the native meniscus and may provide an effective long-term solution for OA patients, alleviate pain, and restore joint function. The goal of the current study was to investigate the potential effect of an artificial medial meniscus implant on the function of the lateral compartment of the knee and on the potential alterations in load distribution between the two compartments under static axial loading, using advanced piezo-resistive sensors. We used an integrated in situ/in vivo experimental approach combining contact pressure measurements of cadaveric knees with MRI joint space measurements of 72 mild OA patients. We employed this integrated approach to evaluate the mechanical consequences in both the medial (treated) and lateral knee compartments of two levels of meniscectomy and implantation of an artificial meniscus implant. Partial and subtotal meniscectomies of the medial meniscus resulted in statistically significant decrease in contact areas (p = 0.008 and p < 0.0001, respectively) and increased contact pressures in the medial compartment; however, implantation of the artificial meniscus implant restored the average contact pressure to 93 ± 14% of its pre-meniscectomy, intact value. Additionally, we found that neither the two different grades of medial meniscectomies, nor implantation of the artificial medial meniscus implant affected the lateral compartment of the knee. The MRI data from the patient cohort facilitated the integration of real-life clinical results together with the laboratory measurements from our cadaveric study, as these two approaches complement each other. We conclude that the use of the artificial medial meniscus implant may re-establish normal load distribution across the articulating surfaces of the medial compartment and not increase loading across the lateral knee compartment.

Quantification of in vitro wear of a synthetic meniscus implant using gravimetric and micro-CT measurements.

A synthetic meniscus implant was recently developed for the treatment of patients with mild to moderate osteoarthritis with knee pain associated with medial joint overload. The implant is distinctively different from most orthopedic implants in its pliable construction, and non-anchored design, which enables implantation through a mini-arthrotomy without disruption to the bone, cartilage, and ligaments. Due to these features, it is important to show that the material and design can withstand knee joint conditions. This study evaluated the long-term performance of this device by simulating loading for a total of 5 million gait cycles (Mc), corresponding to approximately five years of service in-vivo. All five implants remained in good condition and did not dislodge from the joint space during the simulation. Mild abrasion was detected by electron microscopy, but µ-CT scans of the implants confirmed that the damage was confined to the superficial surfaces. The average gravimetric wear rate was 14.5 mg/Mc, whereas volumetric changes in reconstructed µ-CT scans point to an average wear rate of 15.76 mm(3)/Mc (18.8 mg/Mc). Particles isolated from the lubricant had average diameter of 15 µm. The wear performance of this polycarbonate-urethane meniscus implant concept under ISO-14243 loading conditions is encouraging.

Hybrid wound dressings with controlled release of antibiotics: Structure-release profile effects and in vivo study in a guinea pig burn model.

Over the last decades, wound dressings have evolved from a crude traditional gauze dressing to tissue-engineered scaffolds. Many types of wound dressing formats are commercially available or have been investigated. We developed and studied hybrid bilayer wound dressings which combine a drug-loaded porous poly(dl-lactic-co-glycolic acid) top layer with a spongy collagen sublayer. Such a structure is very promising because it combines the advantageous properties of both layers. The antibiotic drug gentamicin was incorporated into the top layer for preventing and/or defeating infections. In this study, we examined the effect of the top layer's structure on the gentamicin release profile and on the resulting in vivo wound healing. The latter was tested on a guinea pig burn model, compared to the neutral non-adherent dressing material Melolin® (Smith & Nephew) and Aquacel® Ag (ConvaTec). The release kinetics of gentamicin from the various studied formulations exhibited burst release values between 8% and 38%, followed by a drug elution rate that decreased with time and lasted for at least 7 weeks. The hybrid dressing, with relatively slow gentamicin release, enabled the highest degree of wound healing (28%), which is at least double that obtained by the other dressing formats (8-12%). It resulted in the lowest degree of wound contraction and a relatively low amount of inflammatory cells compared to the controls. This dressing was found to be superior to hybrid wound dressings with fast gentamicin release and to the neat hybrid dressing without drug release. Since this dressing exhibited promising results and does not require frequent bandage changes, it offers a potentially valuable concept for treating large infected burns.

In-vivo evaluation of the kinematic behavior of an artificial medial meniscus implant: A pilot study using open-MRI.

BACKGROUND: In this pilot study we wanted to evaluate the kinematics of a knee implanted with an artificial polycarbonate-urethane meniscus device, designed for medial meniscus replacement. The static kinematic behavior of the implant was compared to the natural medial meniscus of the non-operated knee. A second goal was to evaluate the motion pattern, the radial displacement and the deformation of the meniscal implant. METHODS: Three patients with a polycarbonate-urethane implant were included in this prospective study. An open-MRI was used to track the location of the implant during static weight-bearing conditions, within a range of motion of 0° to 120° knee flexion. Knee kinematics were evaluated by measuring the tibiofemoral contact points and femoral roll-back. Meniscus measurements (both natural and artificial) included anterior-posterior meniscal movement, radial displacement, and meniscal height. FINDINGS: No difference (P>0.05) was demonstrated in femoral roll-back and tibiofemoral contact points during knee flexion between the implanted and the non-operated knees. Meniscal measurements showed no significant difference in radial displacement and meniscal height (P>0.05) at all flexion angles, in both the implanted and non-operated knees. A significant difference (P ≤ 0.05) in anterior-posterior movement during flexion was observed between the two groups. INTERPRETATION: In this pilot study, the artificial polycarbonate-urethane implant, indicated for medial meniscus replacement, had no influence on femoral roll-back and tibiofemoral contact points, thus suggesting that the joint maintains its static kinematic properties after implantation. Radial displacement and meniscal height were not different, but anterior-posterior movement was slightly different between the implant and the normal meniscus.

Structure-property effects of novel bioresorbable hybrid structures with controlled release of analgesic drugs for wound healing applications.

Over the last decades, wound dressings have developed from the traditional gauze dressing to tissue-engineered scaffolds. A wound dressing should ideally maintain a moist environment at the wound surface, allow gas exchange, act as a barrier to micro-organisms and remove excess exudates. In order to provide these characteristics, we developed and studied bioresorbable hybrid structures which combine a synthetic porous drug-loaded top layer with a spongy collagen sublayer. The top layer, prepared using the freeze-drying of inverted emulsions technique, was loaded with the analgesic drugs ibuprofen or bupivacaine, for controlled release to the wound site. Our investigation focused on the effects of the emulsion's parameters on the microstructure and on the resulting drug-release profile, as well as on the physical and mechanical properties. The structure of the semi-occlusive top layer enables control over vapor transmission, in addition to strongly affecting the drug release profile. Release of the analgesic drugs lasted from several days to more than 100 days. Higher organic:aqueous phase ratios and polymer contents reduced the burst release of both drugs and prolonged their release due to a lower porosity. The addition of reinforcing fibers to this layer improved the mechanical properties. Good binding of the two components, PDLGA and collagen, was achieved due to our special method of preparation, which enables a third interfacial layer in which both materials are mixed to create an "interphase". These new PDLGA/collagen structures demonstrated a promising potential for use in various wound healing applications.

Controlled release of analgesic drugs from porous bioresorbable structures for various biomedical applications.

Pain is one of the most common patient complaints encountered by health professionals and remains the number one cause of absenteeism and disability. In the current study, analgesic-eluting bioresorbable porous structures prepared using the freeze-drying of inverted emulsions technique were developed and studied. These drug-eluting structures can be used for coating fibers or implants, or for creating standalone films. They are ideal for forming biomedically important structures that can be used for various applications, such as wound dressings that provide controlled release of analgesics to the wound site in addition to their wound dressing role. Our investigation focused on the effects of the inverted emulsion's parameters on the shell microstructure and on the resulting drug-release profile of ibuprofen and bupivacaine. The release profiles of ibuprofen formulations exhibited a diffusion-controlled pattern, ranging from several days to 21 days, whereas bupivacaine formulations exhibited an initial burst release followed by a three-phase release pattern over a period of several weeks. Higher organic to aqueous phase ratios and higher polymer contents reduced the burst release of both drugs and prolonged their release due to lower porosity. Overall, the drug-eluting porous structures loaded with either ibuprofen or bupivacaine demonstrated a promising potential for use in various applications that require pain relief.

Viscoelastic properties of a synthetic meniscus implant.

There are significant potential advantages for restoration of meniscal function using a bio-stable synthetic implant that combines long-term durability with a dependable biomechanical performance resembling that of the natural meniscus. A novel meniscus implant made of a compliant polycarbonate-urethane matrix reinforced with high modulus ultrahigh molecular weight polyethylene fibers was designed as a composite structure that mimics the structural elements of the natural medial meniscus. The overall success of such an implant is linked on its capability to replicate the stress distribution in the knee over the long-term. As this function of the device is directly dependent on its mechanical properties, changes to the material due to exposure to the joint environment and repeated loading could have non-trivial influences on the viscoelastic properties of the implant. Thus, the goal of this study was to measure and characterize the strain-rate response, as well as the viscoelastic properties of the implant as measured by creep, stress relaxation, and hysteresis after simulated use, by subjecting the implant to realistic joint loads up to 2 million cycles in a joint-like setting. The meniscus implant behaved as a non-linear viscoelastic material. The implant underwent minimal plastic deformation after 2 million fatigue loading cycles. Under low compressive loads, the implant was fairly flexible, and able to deform relatively easily (E=120-200 kPa). However as the compressive load applied on the implant was increased, the implant became stiffer (E=3.8-5.2 MPa), to resist deformation. The meniscus implant appears well-matched to the viscoelastic properties of the natural meniscus, and importantly, these properties were found to remain stable and minimally affected by potentially degradative and loading conditions associated with long-term use.

Long-term evaluation of a compliant cushion form acetabular bearing for hip joint replacement: a 20 million cycles wear simulation.

Soft bearing materials that aim to reproduce the tribological function of the natural joint are gaining popularity as an alternative concept to conventional hard bearing materials in the hip and knee. However, it has not been proven so far that an elastic cushion bearing can be sufficiently durable as a long term (∼20 years) articulating joint prosthesis. The use of new bearing materials should be supported by accurate descriptions of the implant following usage and of the number, volume, and type of wear particles generated. We report on a long-term 20 million cycle (Mc) wear study of a commercial hip replacement system composed of a compliant polycarbonate-urethane (PCU) acetabular liner coupled to a cobalt-chromium alloy femoral head. The PCU liner showed excellent wear characteristics in terms of its low and steady volumetric wear rate (5.8-7.7 mm(3)/Mc) and low particle generation rate (2-3 × 10(6) particles/Mc). The latter is 5-6 orders of magnitude lower than that of highly cross-linked polyethylene and 6-8 orders of magnitude lower than that of metal-on-metal bearings. Microscopic analysis of the implants after the simulation demonstrated a low damage level to the implants' articulating surfaces. Thus, the compliant PCU bearing may provide a substantial advantage over traditional bearing materials.

Wear rate evaluation of a novel polycarbonate-urethane cushion form bearing for artificial hip joints.

There is growing interest in the use of compliant materials as an alternative to hard bearing materials such as polyethylene, metal and ceramics in artificial joints. Cushion form bearings based on polycarbonate-urethane (PCU) mimic the natural synovial joint more closely by promoting fluid-film lubrication. In the current study, we used a physiological simulator to evaluate the wear characteristics of a compliant PCU acetabular buffer, coupled against a cobalt-chrome femoral head. The wear rate was evaluated over 8 million cycles gravimetrically, as well as by wear particle isolation using filtration and bio-ferrography (BF). The gravimetric and BF methods showed a wear rate of 9.9-12.5mg per million cycles, whereas filtration resulted in a lower wear rate of 5.8mg per million cycles. Bio-ferrography was proven to be an effective method for the determination of wear characteristics of the PCU acetabular buffer. Specifically, it was found to be more sensitive towards the detection of wear particles compared to the conventional filtration method, and less prone to environmental fluctuations than the gravimetric method. PCU demonstrated a low particle generation rate (1-5×106 particles per million cycles), with the majority (96.6%) of wear particle mass lying above the biologically active range, 0.2-10µm. Thus, PCU offers a substantial advantage over traditional bearing materials, not only in its low wear rate, but also in its osteolytic potential.