Skin temperature of the knee was effectively reduced when using a new continuous cold-flow cryocompression device: a randomised controlled crossover trial.

OBJECTIVE: To determine which temperature settings on a new continuous cold-flow cryocompression device effectively reduce knee skin temperature to 10-15 °C, where pain and swelling are expected to be attenuated. DESIGN: Randomised controlled crossover trial. SETTING: University laboratory. PARTICIPANTS: 32 healthy adult participants recruited (1 dropout) with no contraindications to cryocompressive therapy. INTERVENTION: A k-type thermocouple was used to record skin temperature at baseline and every five minutes during a 30-minute cryocompression treatment in a control condition and when using four different device temperature settings (6 °C, 8 °C, 10 °C, and 12 °C) on a continuous cold-flow cryocompression device. Conditions were labelled Control, Con-6, Con-8, Con-10, and Con-12, respectively. MAIN OUTCOME MEASURES: Skin temperature change (°C) throughout cryocompression; time taken (mins) to achieve skin temperature < 15 °C; and the difference between final skin temperature and device temperature setting (°C). RESULTS: Median (IQR) skin temperature after cryocompression was 32.1 °C (29.3-33.4), 12.8 °C (12.1-14.6), 14.3 °C (13.8-15.7), 16.1 °C (15.2-17.3), and 17.7 °C (16.9-18.9) for the Control condition and Con-6, Con-8, Con-10 and Con-12, respectively. It took 20 min (Con-6) and 25 min (Con-8) for skin temperature to reach < 15 °C. A median (IQR) difference of 6.8 °C (6.1-8.6), 6.3 °C (5.8-7.7), 6.1 °C (5.2-7.3), and 5.7 °C (4.9-6.9) for Con-6, Con-8, Con-10, and Con-12, respectively was observed between device temperature setting and final skin temperature. CONCLUSIONS: The device is recommended as it reduced skin temperature to the therapeutic range of 10-15 °C during a 30-minute treatment when using the 6 °C or 8 °C device temperature settings. Future research should determine optimal treatment lengths for cryocompression. CONTRIBUTION OF THE PAPER.

A randomised crossover trial of five cryocompression devices' ability to reduce skin temperature of the knee.

BACKGROUND: The application of cold and pressure to the knee is a common part of post-operative rehabilitation. Skin temperature should be reduced to within 10-15 °C to optimise the therapeutic benefits of cryocompression. The purpose of this study was to investigate the ability of five different cryocompression devices to reduce skin temperature to within this therapeutic range. MATERIALS AND METHODS: 32 healthy adult participants (mean (SD): age 26.3 (7.9) years; BMI 24.8 (2.7) kg/m2; 20 males) were recruited for this randomised crossover study. Skin temperature was measured 20 mm distal to the patella using a k-type thermocouple every five minutes during a 30-minute treatment with one of five different cryocompression devices (Physiolab S1, GameReady, Cryo/Cuff, VPulse, and a Gel Wrap). Changes in skin temperature over time were compared to baseline within and between conditions. A subjective rating of comfort was also recorded for each device. RESULTS: The Physiolab S1 and GameReady devices caused significantly lower skin temperatures compared to the VPulse, Gel Wrap, and Cryo/Cuff after 30 minutes (p<0.05). 87-96% reported a positive comfort rating for the Physiolab S1, VPulse, Cryo/Cuff and Gel Wrap, whereas 53% of participants reported a positive comfort rating for the GameReady. CONCLUSIONS: Only the Physiolab S1 and GameReady devices reduced skin temperature of the knee to within the target range of 10-15 °C. The Physiolab S1 was reportedly more comfortable than the GameReady. Clinicians should be aware of the performance differences of different cryocompression devices to understand which is most likely to provide an effective dose of cold therapy to a joint.

Return to Physical Activity After High Tibial Osteotomy or Unicompartmental Knee Arthroplasty: A Systematic Review and Pooling Data Analysis.

BACKGROUND: The 2 most common definitive surgical interventions currently performed for the treatment of medial osteoarthritis of the knee are medial opening wedge high tibial osteotomy (HTO) and medial unicompartmental knee arthroplasty (UKA). Research exists to suggest that physically active patients may be suitably indicated for either procedure despite HTO being historically indicated in active patients and UKA being more appropriate for sedentary individuals. PURPOSE: To help consolidate the current indications for both procedures regarding physical activity and to ensure that they are based on the best information presently available. STUDY DESIGN: Systematic review. METHODS: A search of the literature via the MEDLINE, Embase, and PubMed databases was conducted independently by 2 reviewers in accordance with the PRISMA (Preferred Reporting Items for Systematic Meta-Analyses) guidelines. Studies that reported patient physical activity levels with the Tegner activity score were eligible for inclusion. Patient demographics, operative variables, and patient-reported outcome scores were abstracted from the included studies. RESULTS: Thirteen eligible studies were included, consisting of 401 knees that received HTO (399 patients) and 1622 that received UKA (1400 patients). The patients' mean age at surgery was 48.4 years for the HTO group and 60.6 years for the UKA group. Mean follow-up was 46.6 months (HTO) and 53.4 months (UKA). All outcome scores demonstrated an equal or improved score for activity and knee function regardless of the operation performed. Operative variables during HTO had a larger effect on outcome than during UKA. CONCLUSION: Patients who underwent HTO were more physically active pre- and postoperatively, but patients undergoing UKA experienced an overall greater increase in their physical activity levels and knee function according to Tegner and Lysholm scores. Activity after HTO may be influenced by operative factors such as the implant used and the decision to include a graft material in the osteotomy gap, although this requires further research. Some studies found that patients were able to return to physical activity postoperatively despite having an age or body mass index that would traditionally be a relative contraindication for HTO or UKA.

Mechanical strength of a new plate compared to six previously tested opening wedge high tibial osteotomy implants.

BACKGROUND: This study aimed to assess the mechanical static and fatigue strength provided by the FlexitSystem plate in medial opening wedge high tibial osteotomies (MOWHTO), and to compare it to six previously tested implants: the TomoFix small stature, the TomoFix standard, the ContourLock, the iBalance, the second generation PEEKPower and the size 2 Activmotion. Thus, this will provide surgeons with data that will help in the choice of the most appropriate implant for MOWHTO. METHODS: Six fourth-generation tibial bone composites underwent a MOWHTO and each was fixed using six FlexitSystem plates, according to standard techniques. The same testing procedure that has already been previously defined, used and published, was used to investigate the static and dynamic strength of the prepared bone-implant constructs. The test consisted of static loading and cyclical loading for fatigue testing. RESULTS: During static testing, the group constituted by the FlexitSystem showed a fracture load higher than the physiological loading of slow walking (3.7 kN > 2.4 kN). Although this fracture load was relatively small compared to the average values for the other Implants from our previous studies, except for the TomoFix small stature and the Contour Lock. During fatigue testing, FlexitSystem group showed the smallest stiffness and higher lifespan than the TomoFix and the PEEKPower groups. CONCLUSIONS: The FlexitSystem plate showed sufficient strength for static loading, and average fatigue strength compared to the previously tested implants. Full body dynamic loading of the tibia after MOWHTO with the investigated implants should be avoided for at least 3 weeks. Implants with a wider T-shaped proximal end, positioned onto the antero-medial side of the tibia head, or inserted in the osteotomy opening in a closed-wedge construction, provided higher mechanical strength than implants with small a T-shaped proximal end, centred onto the medial side of the tibia head.

The biomechanical effects of allograft wedges used for large corrections during medial opening wedge high tibial osteotomy.

The inclusion of an allograft wedge during medial opening wedge high tibial osteotomy has been shown to lead to satisfactory time-to-union in larger corrections (>10°). Such large corrections are associated with greater incidences of intraoperative hinge fracture and reduced construct stability. The purpose of this study was to investigate the biomechanical stability that an allograft wedge brings to an osteotomy. Ten medium-size fourth generation artificial sawbone tibiae underwent 12 mm biplanar medial opening wedge high tibial osteotomy with a standard Tomofix plate. Five tibiae had an allograft wedge inserted into the osteotomy gap prior to plate fixation (allograft group). The gap in the remaining tibiae was left unfilled (control group). Each group underwent static compression testing and cyclical fatigue testing until failure of the osteotomy. Peak force, valgus malrotation, number of cycles, displacement and stiffness around the tibial head were analysed. Intraoperative hinge fractures occurred in all specimens. Under static compression, the allograft group withstood higher peak forces (6.01 kN) compared with the control group (5.12 kN). Valgus malrotation was lower, and stiffness was higher, in the allograft group. During cyclical fatigue testing, results within the allograft group were more consistent than within the control group. This may indicate more predictable results in large osteotomies with an allograft. Tibial osteotomies with allograft wedges appear beneficial for larger corrections, and in cases of intraoperative hinge fracture, due to the added construct stability they provide, and the consistency of results compared with tibial osteotomies without a graft.

Graft materials provide greater static strength to medial opening wedge high tibial osteotomy than when no graft is included.

BACKGROUND: The purpose of this study was to compare the stability of medial opening-wedge high tibial osteotomy (MOWHTO) with and without different graft materials. Good clinical and radiological outcomes have been demonstrated when either using or not using graft materials during MOWHTO. Variations in the biomechanical properties of different graft types, regarding the stability they provide a MOWHTO, have not been previously investigated. METHODS: A 10 mm biplanar MOWHTO was performed on 15 artificial sawbone tibiae, which were fixed using the Activmotion 2 plate. Five bones had OSferion60 wedges (synthetic group), five had allograft bone wedges (allograft group), and five had no wedges (control group) inserted into the osteotomy gap. Static compression was applied axially to each specimen until failure of the osteotomy. Ultimate load, horizontal and vertical displacements were measured and used to calculate construct stiffness and valgus malrotation of the tibial head. RESULTS: The synthetic group failed at 6.3 kN, followed by the allograft group (6 kN), and the control group (4.5 kN). The most valgus malrotation of the tibial head was observed in the allograft group (2.6°). The synthetic group showed the highest stiffness at the medial side of the tibial head (9.54 kN·mm- 1), but the lowest stiffness at the lateral side (1.59 kN·mm-1). The allograft group showed high stiffness on the medial side of the tibial head (7.54 kN·mm- 1) as well as the highest stiffness on the lateral side (2.18 kN·mm- 1). CONCLUSIONS: The use of graft materials in MOWHTO results in superior material properties compared to the use of no graft. The static strength of MOWHTO is highest when synthetic grafts are inserted into the osteotomy gap. Allograft wedges provide higher mechanical strength to a MOWHTO than when no graft used. In comparison to the synthetic grafts, allograft wedges result in the stiffness of the osteotomy being more similar at the medial and lateral cortices.

Numerical comparative study of five currently used implants for high tibial osteotomy: realistic loading including muscle forces versus simplified experimental loading.

BACKGROUND: Many different fixation devices are used to maintain the correction angle after medial open wedge high tibial osteotomy (MOWHTO). Each device must provide at least sufficient mechanical stability to avoid loss of correction and unwanted fracture of the contralateral cortex until the bone heals. In the present study, the mechanical stability of following different implants was compared: the TomoFix small stature (sm), the TomoFix standard (std), the Contour Lock, the iBalance and the second generation PEEKPower. Simplified loading, usually consisting of a vertical load applied to the tibia plateau, is used for experimental testing of fixation devices and also in numerical studies. Therefore, this study additionally compared this simplified experimental loading with a more realistic loading that includes the muscle forces. METHOD: Two types of finite element models, according to the considered loading, were created. The first type numerically simulated the static tests of MOWHTO implants performed in a previous experimental biomechanical study, by applying a vertical compressive load perpendicularly to the plateau of the osteotomized tibia. The second type included muscle forces in finite element models of the lower limb with osteotomized tibiae and simulated the stance phase of normal gait. Section forces in the models were determined and compared. Stresses in the implants and contralateral cortex, and micromovements of the osteotomy wedge, were calculated. RESULTS: For both loading types, the stresses in the implants were lower than the threshold values defined by the material strength. The stresses in the lateral cortex were smaller than the ultimate tensile strength of the cortical bone. The implants iBalance and Contour Lock allowed the smallest micromovements of the wedge, while the PEEKPower allowed the highest. There was a correlation between the micromovements of the wedge, obtained for the simplified loading of the tibia, and the more realistic loading of the lower limb at 15% of the gait cycle (Pearson's value r = 0.982). CONCLUSIONS: An axial compressive load applied perpendicularly to the tibia plateau, with a magnitude equal to the first peak value of the knee joint contact forces, corresponds quite well to a realistic loading of the tibia during the stance phase of normal gait (at 15% of the gait cycle and a knee flexion of about 22 degrees). However, this magnitude of the knee joint contact forces overloads the tibia compared to more realistic calculations, where the muscle forces are considered. The iBalance and Contour Lock implants provide higher rigidity to the bone-implant constructs compared to the TomoFix and the PEEKPower plates.

Static and fatigue strength of a novel anatomically contoured implant compared to five current open-wedge high tibial osteotomy plates.

BACKGROUND: The purpose of the present study was to compare the mechanical static and fatigue strength of the size 2 osteotomy plate "Activmotion" with the following five other common implants for the treatment of medial knee joint osteoarthritis: the TomoFix small stature, the TomoFix standard, the Contour Lock, the iBalance and the second generation PEEKPower. METHODS: Six fourth-generation tibial bone composites underwent a medial open-wedge high tibial osteotomy (HTO), according to standard techniques, using size 2 Activmotion osteotomy plates. All bone-implant constructs were subjected to static compression load to failure and load-controlled cyclic fatigue failure testing, according to a previously defined testing protocol. The mechanical stability was investigated by considering different criteria and parameters: maximum forces, the maximum number of loading cycles, stiffness, the permanent plastic deformation of the specimens during the cyclic fatigue tests, and the maximum displacement range in the hysteresis loops of the cyclic loading responses. RESULTS: In each test, all bone-implant constructs with the size 2 Activmotion plate failed with a fracture of the lateral cortex, like with the other five previously tested implants. For the static compression tests the failure occurred in each tested implant above the physiological loading of slow walking (> 2400 N). The load at failure for the Activmotion group was the highest (8200 N). In terms of maximum load and number of cycles performed prior to failure, the size 2 Activmotion plate showed higher results than all the other tested implants except the ContourLock plate. The iBalance implant offered the highest stiffness (3.1 kN/mm) for static loading on the lateral side, while the size 2 Activmotion showed the highest stiffness (4.8 kN/mm) in cyclic loading. CONCLUSIONS: Overall, regarding all of the analysed strength parameters, the size 2 Activmotion plate provided equivalent or higher mechanical stability compared to the previously tested implant. Implants with a metaphyseal slope adapted to the tibia anatomy, and positioned more anteriorly on the proximal medial side of the tibia, should provide good mechanical stability.