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Official websites use. Share sensitive information only on official, secure websites. TJa: Specimen preparation and histomorphometry. TJa: Statistical analysis. TJa wrote the first draft of the manuscript. All authors have read and approved the final submitted manuscript. Early secure fixation of total joint replacements is crucial for long-term survival. Antiresorptive agents such as bisphosphonates have been shown to increase implant fixation. We investigated whether local delivery of zoledronate from poly-D, L-lactide PDLLA -coated implants could improve implant fixation and osseointegration. Experimental titanium implants were bilaterally inserted press-fit into the proximal tibiae of 10 dogs. The contralateral implant was uncoated and used as control. Observation period was 12 weeks. Implant fixation was evaluated with histomorphometry and biomechanical push-out test. We found an approximately twofold increase in all biomechanical parameters when comparing data from the zoledronate group with their respective controls. Histomorphometry showed increased amount of preserved bone and increased bone formation around the zoledronate implants. This study indicates that local delivery of zoledronate from a PDDLA coating has the potential to increase implant fixation. Longevity of total joint replacement relies upon early secure mechanical stability and sustained osseointegration in order to prevent migration and implant loosening. Bisphosphonates are strong inhibitors of bone resorption. Bisphosphonate can be administrated locally or systemically. Local bisphosphonate delivery has the potential to reach high concentrations without systemic adverse effects. We have previously shown that soaking bone in bisphosphonate before implantation can increase osseointegration and implant fixation. Different coatings, including bisphospho-nate immobilized in a cross-linked fibrinogen layer and hydroxyapatite-adsorbed bisphosphonate, have been tested experimentally 9 , 20 A general finding is increased peri-implant bone density. Zoledronate is a third-generation nitrogen-containing bisphosphonate. We have previously shown that soaking allograft in zoledronate and rinsing away unbound zoledronate away can improve implant osseointegration. The aim of this large animal study was to investigate the effect of PDDLA releasing zoledronate on implant osseointegration and fixation. We hypothesized that zoledronate eluted from a PDLLA coating would increase biomechanical fixation and implant osseointegration in a canine model using porouscoating titanium implant after 12 weeks of observation. We used 10 skeletally mature female hound dogs with a median weight of 29 kg range, 27—32 kg. Institutional guidelines for treatment and care of experimental animals were followed. Two unrelated studies were conducted in this set of dogs. One study investigating the effect of different graft substitutes placed around implants inserted into the proximal part of the humerus. Another study in the medial femoral condyle investigating a surgical technique used to improve implant fixation in a revision model. None of the to studies included drugs that potentially could influence this study. Our study was designed as a paired randomized study with 20 implants. We inserted one porous-coated titanium implant into the medial proximal aspect of each tibia. We inserted one PDLLA-zoledronate coated implant into one of the tibiae and our control implant in the contralateral tibia. Each dog served as its own control. We observed the animals for 12 weeks. We determine sample size from power estimate based on previous studies. Two extra animals were added to the calculated sample size of eight to counteract decreased power if implants from one or two animals were lost for subsequent analysis. Our 20 implants consisted of a titanium alloy core Ti-6Al-4V onto which a 0. The implants had a nominal diameter of 6. The porous-bead coating was manufactured by Depuy Orthopaedics, Inc. Warsaw, IN and donated as a gift. Implants were dipped twice in the solution and air dried under sterile conditions. Based on coating experiments, where the implants where weighed before and after coating, an estimated 0. All surgical procedures were performed under sterile conditions with the animals under general anaesthesia. We exposed the proximal anteromedial surface of the tibia through a medial incision. Then we inserted a 2. The guidewire was inserted 10 mm distal of the tibia plateau. Over the guidewire, we used a cannulated drill with an outer diameter of 6. All drilling was done water-cooled and at low speed with two revolutions per second to avoid thermal trauma to the bone. After removing bone-debris and irrigating the cavity, we inserted the implant. We inserted our implant in exact-fit with light hammer blows. In order to avoid potential contamination of our control implant with zoledronate, we inserted the control implant before inserting the PDDLA-zoledronate implant in the contralateral tibia. Antibiotics Rocephin; Sandoz GmbH, Kundl, Austria were administered immediately before surgery and 3 days postoperatively. All dogs were euthanized 12 weeks postoperatively. Two specimens containing a part of the implant and surrounding bone were cut from each tibia perpendicular to the long axis of the implant using a water-cooled band saw Exact Apparatebau, Nordenstedt, Germany Fig. The first and most superficial specimens, with a thickness of 3. The second specimens, with a thickness of 6. Preparation of specimens and subsequent evaluation was performed blinded. Schematic diagram showing the specimen preparation. Each bone-implant specimen is cut into two pieces: A 6. We placed the specimens on a metal support jig with a 7. Implants were pushed from the peripheral side towards the inside of the bone. A preload of 2 N defined the start of the test. Maximum shear strength MPa was determined from the maximum force applied until failure of the bone-implant interface. Failure was defined as the maximum force measured on a load versus displacement curve. We normalized all push-out parameters by the cylindrical surface area of the transverse implant section, as determined from the measured thickness of the individual section tested. Before making the sections, the implant was randomly rotated around its long axis. The sections were cut parallel to this axis. With this protocol, bone was stained green and non-mineralized tissue red. Histomorphometrical specimens were during preparation given a unique identification number by a person not related to specimen preparation. The unique identification number enabled us to do blinded histomorphometry. Bone-to-implant contact was defined as the implant surface covered with woven or lamellar bone and was estimated by manually counting intercepts between sine-weighted lines and surface covered with bone. Bone volume fractions were estimated by manual point counting to determine the fraction of woven and lamellar bone in two zones around the implants: Zone 1 from the middle of the porous-bead coating and mm into surrounding bone, and Zone 2 in the volume — mm from the middle of the porous-bead coating. Newly formed woven bone was identified by the lack of organization and large, round osteocyte lacunae. Lamellar bone was identified by its highly organized lamellas and lamella-oriented long, oval cell lacunae. We used Intercooled Stata 9. Statistical analyses were done on ratios between paired data, which were not normally distributed. An absolute difference between the logarithms of a pair of data equals the logarithm of the ratio within the pair. Results are presented as medians of relative differences between the paired data. Correlation analyses were done between relative increases in biomechanical and histomorphometrical parameters. All assumptions for correlation analysis were met. All dogs completed the weeks observation period. No clinical sign of infection were present at time of euthanasia. Implants from one animal for biomechanical testing was excluded as a result of technical error during cutting procedure for one of the two implants. Press-fit implants coated with PDDLA-containing zoledronate had better biomechanical fixation compared with those in the control group Fig. The improvement in biomechanical fixation was consistent for all pairs of implants. We found that local zoledronate was able to preserve lamellar bone and increase formation of woven bone in both zone 1 and 2 around the implants Figs. Paired data are connected by a line. No lamellar bone was observed in contact with the implant surfaces in either group. The histomorphometrical findings are reflected in a histological evaluation of the implants. The most striking histological difference between the two treatment groups is a relatively dense zone of cancellous bone around the zoledronate implants. Further away from the implant surface no histological difference was observed between the two treatment groups. Representative photomicrographs of samples from the same animal. Implant appears as black, marrow as red, and bone as green. Note the increased amount of bone around the zoledronate implant. The purpose of this study was to investigate whether zoledronate delivered locally from a PDDLA coating on a Ti-coated implant could improve osseointegration and biomechanical implant fixation. We found that zoledronate increased both the amount of new woven bone and old lamellar bone around the implants and improved the biomechanical implant fixation. Our experimental model was intended to represent the portion of a cementless human joint replacement placed in cancellous bone. The canine cancellous bone was chosen because it resembles human bone in terms of composition, density, and quality. This study has limitations. This canine implant model is unloaded and thereby limited, as the effects of loading are not addressed. We choose to use a control implant not coated with PDDLA in order to imitate the clinical setting with an uncemented Ti-implant. Thus, in the context of this study any positive effect cannot solely be attributed to zoledronate, but to the combination of PDLLA and zoledronate. We know from a previous study that implants coated with pure PDDLA do not stimulate bone formation in a similar implant model. This was done in order not to contaminate the control implant with zoledronate. The surgeon was thereby not blinded and a potential bias could be introduced. Only one time point was investigated and long-term should be done with caution. In this study, we were also limited to use of a single dose of zoledronate. This is in accordance with previous studies where the bone bed was soaked in bisphosphonate before insertion of experimental implants. In spite of improved biomechanical fixation of the zoledronate implants, it is of interest to note that no significant differences with respect to fractions of lamellar or woven bone were observed on the implant surfaces themselves. This could indicate that the weakest link in the chain fixating the implant to bone might be the peri-implant bone and not the bone in contact with the implant surface. We have previously found it difficult to improve fixation of experimental implants inserted press-fit. With the dose of zoledronate used in this study we were able to increase formation of woven bone in a 1 mm zone around the implants. One explanation for this increased formation of woven bone could be the preserving effect of zoledronate on the lamellar bone. The surface of the preserved lamellar bone could act as a scaffold that by means of osteoconduction stimulate formation of new bone. Similar effect has been observed in others studies. We did not find any difference in the amount of woven bone in contact with the implant surface between the two groups. The implants used in this study were porous bead coated. As a consequence, most of the implant surface itself was located within the porosity of the implant. We did not find any lamellar bone within the porosity in either the zoledronate or control implants. If zoledronate increases new bone formation by preserving lamellar bone, then the lack of lamellar bone with in implant porosity could explain the lack in difference in woven bone between the two groups. Another explanation for the absence of a difference would be that the potential positive effect of zoledronate is balanced by a potential negative effect of PDDLA. Other studies have shown that implant fixation and osseointegration can be increased by systemic administration or local treatment of the bone bed. Delivering the zoledronate by elution from a PDDLA coating will ensure a reproducible method with a controlled target dose compared to soaking the bone bed in a zoledronate solution and rinsing away excess unbound zoledronate. We know from previous studies that soaking the bone bed in a bisphosphonate solution can increase new bone formation at least 1 mm away from the implant surface. Zoledronate eluted from the PDDLA coating has to be transported into the bone bed in order to be effective. With this study, we are able to demonstrate preservation of lamellar bone and increased formation of woven bone up to 1 mm away from the implant surface, when PDLLA is used. Our finding suggests that there may be a clinical advantage in coating an implant with PDDLA containing zoledronate. In conclusion, this study demonstrated that zoledro-nate in a PDDLA coating has the potential to improve osseointegration and implant fixation in a canine model. Local delivery of zoledronate to the bone bed from a PDLLA coating appears to be a targeted and reproducible method that might have the potential to increase early fixation and longevity of total joint replacements. Studies investigating dose-response relationships and longer observation periods are needed. Implants was donated by Depuy Depuy Orthopaedics, Inc. As a library, NLM provides access to scientific literature. J Orthop Res. Published in final edited form as: J Orthop Res. Find articles by Thomas Jakobsen. Find articles by Joan E Bechtold. Find articles by Thomas Jensen. Find articles by Stefan Greiner. Find articles by Marianne T Vestermark. Issue date Jan. PMC Copyright notice. The publisher's version of this article is available at J Orthop Res. Open in a new tab. Similar articles. Add to Collections. Create a new collection. Add to an existing collection. Choose a collection Unable to load your collection due to an error Please try again. Add Cancel.

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