Feasibility of model-based Roentgen Stereophotogrammetric Analysis to evaluate early migration of the trapeziometacarpal joint prosthesis.

BACKGROUND: The purpose of this study was to determine the feasibility of Roentgen Stereophotogrammetric Analysis (RSA) in total joint arthroplasty of the trapeziometacarpal (TMC) joint of the thumb. METHODS: In five cadaveric hands the TMC-joint was replaced by the Surface Replacement Trapeziometacarpal prosthesis (SR™ TMC prosthesis; Avanta, San Diego, CA) and tantalum beads of 0.8 mm were implanted for RSA. RSA radiographs in two directions were made in ten positions to calculate the measurement error. Migration values from zero are indicative for the measurement error. The number of detected markers was recorded. RESULTS: The accuracy analysis showed that for the translations the mean measurement error varied between 0.003 mm (SD 0.057) and 0.055 mm (SD 0.133). For the rotations values ranged from 0.034° (SD 1.759) to 0.502° (SD 1.617). CONCLUSIONS: RSA analysis of the SR™ TMC prosthesis is feasible. The measurement error is good for the translations but high for the rotations. The latter is due to the close position of the markers relative to each other. Level of evidence III.

Model-based roentgen stereophotogrammetric analysis of the surface replacement trapeziometacarpal total joint arthroplasty.

The primary aim of this clinical and radiostereometric study was to study the migration pattern of the surface replacement trapeziometacarpal joint prosthesis (SRTMTMC, Avanta®, San Diego, CA). The secondary aims were to assess patient-related outcomes and prosthesis survival 5 years after surgery. Ten patients received the prosthesis. Radiostereometric radiographs were obtained 6 weeks, 6 months, 1 year and 5 years post-operatively and were analysed using model-based software. All patients completed DASH and Nelson Hospital scores at these follow-ups. Mean translations varied between 0.0 and 0.5 mm after 5 years. Rotation values could be calculated in six patients and mean rotations varied between -0.3 and 2.3°, although the precision of rotation values seems to be poor. The 5-year survival rate was 80%. Mean pre-operative DASH and Nelson Hospital scores were 53 (SD 14) and 51 (SD 13), respectively. Six months post-operatively, the DASH and Nelson Hospital scores had both significantly improved to 25 (SD 20) and 74 (SD 18) and remained high after 5 years. Implant stability was good 5 years post-operatively, and early migration did not predict implant failure in this study. LEVEL OF EVIDENCE: IV.

Soft-tissue response to injectable calcium phosphate cements.

In this study, the soft tissue reaction to two newly developed injectable calcium phosphate bone cements (cement D and W) was evaluated after implantation in the back of goats. For one of the cements (cement D) the tissue reaction was also investigated after varying the concentration of accelerator Na(2)HPO(4) in the cement liquid (resulting in cement D1 and D2). Eight healthy mature female Saanen goats were used. The cement was applied 10min after mixing while it was still moldable and plastic. The material was given a standardized cylindrical shape. Thirty-two implants of each cement formulation were inserted and left in place for 1, 2, 4, and 8weeks. At the end of the study, eight specimens of each material and healing period were available for further analysis. Two specimens were used for X-ray diffraction (XRD) and Fourier Transform Infrared Spectroscopy (FTIR) and six specimens were used for light microscopical evaluation. XRD and FTIR showed that the cements did set as microcrystalline carbonate apatite with the disappearance of monetite from the cements during implantation. Histological analysis showed that after 8weeks of implantation around all materials a thin soft-tissue capsule was formed (thickness ranging from 5 to 15 cell layers) with almost complete absence of inflammatory cells. Only in some specimens a slightly higher inflammatory reaction was observed. This was due to cement surface defects and a zone of dispersed particles near the cement-soft tissue interface. There was almost no resorption of the material after 8 weeks of implantation. In a few 4 and 8weeks samples, small areas of calcification were found in the fibrous capsule surrounding the implants. On the basis of our observations, we conclude that the tested cements were biocompatible and can be used next to soft tissue.

Enhancement of initial stability of press-fit femoral stems using injectable calcium phosphate cement: an in vitro study in dog bones.

In this in vitro study we evaluated the initial stability of cementless femoral stems using an injectable calcium phosphate (Ca-P) cement. The cement was not used to form a cement mantle as is routinely done in PMMA cemented prostheses but functioned as an additive to fill the small gaps that exist between a press-fit placed titanium plasma sprayed implant and the bone bed. Six pair of Beagle femora were used in this study. In a random fashion, one femur of each pair was used for placement of a prosthesis without Ca-P cement, the contralateral was used for press-fit placement after injection of the calcium phosphate cement into the intramedullary canal. The reconstructions were placed in a MTS testing machine, tilted 15 degrees in varsus and 15 degrees of endorotation to obtain a physiological load on the femoral head. The load was applied stepwise from zero to a maximum of 100, 250 and 400 N, respectively. At each loading step the load was applied dynamically at a frequency of 1 Hz for 30 min. Between the loading steps, the load was removed for 10 min to allow elastic recovery. The stability of the stems was determined at each loading step with roentgen-stereophotogrammetric analysis. Results showed that with the prostheses without Ca-P cement the most important displacements were movement into varus (max. 818 microm under 400 N) and subsidence (max. 587 microm under 400 N). The displacements showed large variation. After unloading some elastic recovery occurred. In the specimens with Ca-P cement, displacements were negligible. As determined by an F-test the variations found were significantly smaller for the press-fit+Ca-P cement relative to the press-fit prosthesis at all loading steps (p<0.05). A paired t-test revealed significant differences in the mentioned displacements between the press-fit- and press-fit+Ca-P cement prosthesis at a loading with 400 N (P<0.05). On the basis of these results we conclude that the use of Ca-P cement increases the initial stability of press-fit inserted plasma-sprayed femoral prostheses and corrects for the high variability in displacements found with press-fit insertion of these femoral hip prostheses.

Histological evaluation of the bone response to calcium phosphate cement implanted in cortical bone.

The aim of this study was to investigate the physicochemical and biological properties of a newly developed calcium phosphate cement (CaP cement) implanted in cortical bone. CaP cement was injected as a paste into tibia cortical bone defects in goats. Polymethylmethacrylate (PMMA) bone cement was used as a control. The animals were killed after 3 days, 2, 8, 16 and 24 weeks. X-ray diffraction and Fourier transform infrared spectroscopy performed at retrieved samples showed that the CaP cement had set as a carbonate apatite and remained stable over time. Light microscopic evaluation showed that after 2 weeks the cement was in tight contact with the bone without any inflammatory reaction or fibrous encapsulation. At later time points, the CaP cement implants were totally covered by a thin layer of bone and osteoclasts, present at the interface, which were clearly resorbing the cement. At locations where CaP cement was resorbed, new bone was deposited. Transmission electron microscopy revealed that indeed a seamless contact existed between CaP cement and bone, as characterized by the occurrence of an electron dense line of 50-60 nm thick that covered the CaP cement. Osteoblasts, in contact with the cement, were depositing new bone. Although the bulk of the material was still in situ after 24 weeks, the progressive osteoclast resorption of the cement followed by new bone formation suggests that all of the material may be replaced eventually. In contrast to the CaP cement, the PMMA reference cement was always surrounded by a thin fibrous capsule. The results indicate that the investigated CaP cement is biocompatible, osteoconductive as well as osteotransductive and is a candidate material for use as a bone substitute.

Use of injectable calcium-phosphate cement for the fixation of titanium implants: an experimental study in goats.

This in vivo study evaluated the fixation of two types of titanium implants with the use of an injectable calcium-phosphate (CaP) cement. The cement was either used to create a cement mantle (Type A implant) or as an additive to press-fit placed titanium plasma sprayed implants (Type B implant). The implants were placed in trabecular bone of the medial femoral condyle of goats and left in place for 2 and 10 weeks. Mechanical evaluation of the implant fixation was done by torque testing. This showed that for the Type A implants the calcium-phosphate cement's performance was significantly inferior (P < 0.05) to that of polymethylmethacrylate cement fixation. For the two-week Type B implants a significant increase (P < 0.05) in failure load was found for calcium-phosphate cemented implants compared with just press-fitted Type B implants. Histological evaluation revealed that for Type A implants, failure during torque testing occurred at the implant-cement interface. In contrast, for Type B implants, failure occurred in the bone-implant interface for press-fit-placed devices and in the cement layer for CaP-cemented devices. Further, the CaP cement was found to be overgrown with new formed bone already after 2 weeks of implantation. The cement showed resorption due to regular bone remodeling. On the basis of these observations, it was concluded that the use of injectable CaP cement might facilitate earlier loading of press-fit inserted titanium implants. Nevertheless, the results have to be confirmed in dynamical mechanical as well as loaded in vivo studies.

Trabecular bone response to injectable calcium phosphate (Ca-P) cement.

The aim of this study was to investigate the physicochemical, biological, and handling properties of a new developed calcium phosphate (Ca-P) cement when implanted in trabecular bone. Ca-P cement consisting of a powder and a liquid phase was implanted as a paste into femoral trabecular bone of goats for 3 days and 2, 8, 16, and 24 weeks. The cement was tested using three clinically relevant liquid-to-powder ratios. Polymethylmethacrylate bone cement, routinely used in orthopedics, was used as a control. The Ca-P cement was easy to handle and was fast setting with good cohesion when in contact with body fluids. X-ray diffraction at the different implantation periods showed that the cement had set as an apatite and remained stable over time. Histological evaluation after 2 weeks, performed on 10 microm un-decalcified sections, showed abundant bone apposition on the cement surface without any inflammatory reaction or fibrous encapsulation. At later time points, the Ca-P cement implants were totally covered by a thin layer of bone. Osteoclast-like cells, as present at the interface, had resorbed parts of the cement mass. At locations where Ca-P cement was resorbed, new bone was formed without loss of integrity between the bone bed and the cement. This demonstrated the osteotransductive property of the cement, i.e., resorption of the material by osteoclast-like cells, directly followed by the formation of new bone. Histological and histomorphometrical evaluation did not show any significant differences between the Ca-P cement implanted at the three different liquid/powder ratios. The results indicate that the investigated Ca-P cement is biocompatible, osteoconductive, as well as osteotransductive and is a candidate material for use as a bone substitute.