Randomized, Blinded, Controlled Clinical Trial of Polylactide-Collagen Scaffold in Treatment of Shoulder Osteochondritis Dissecans in Dogs.

OBJECTIVE: The aim of our study was to investigate a degradable polylactide-collagen scaffold (COPLA) in the treatment of shoulder osteochondritis dissecans (OCD) in dogs. STUDY DESIGN: The study was a controlled, randomized, blinded clinical trial with a parallel group design with a 1.5-year follow-up. Twenty dogs with uni- or bilateral shoulder OCD (29 shoulders) were randomized to receive a COPLA or arthroscopic debridement only (Control). The outcome of treatment was assessed with gait and stance analysis, passive range of motion measurement, pain and lameness evaluation, Helsinki Chronic Pain Index, and computed tomography (CT). RESULTS: Eighteen dogs (25 shoulders) completed the study. The clinical outcome variables improved significantly from baseline in COPLA and Control groups after treatment but no significant differences emerged between groups. Significantly fewer COPLA than Control shoulders had osteoarthritis (OA) in CT at 6 months (p = 0.019) but the difference was not significant at 1.5 years. At 1.5 years, all dogs were sound and pain-free in joint palpation, but OA was diagnosed in 13/18 dogs (18/25 shoulders) with CT. CONCLUSION: The results suggest that COPLA scaffold slowed down the development of OA at 6 months but it did not improve the clinical recovery or prevent OA in dogs with shoulder OCD in long-term follow-up at 1.5 years compared with arthroscopic debridement only. Regardless of the treatment method, clinical recovery was good, but OA developed in the majority of dogs.

Load-bearing composite fracture-fixation devices with tailored fibre placement for toy-breed dogs.

Fibre reinforced composites are attractive materials for hard tissue reconstructions, due to the high strength and low flexural modulus. However, lack of contourability in the operation theatre inhibits their clinical applications. The study presents a novel in situ contourable composite implant system for load-bearing conditions. The implant system consists of a thin bioresorbable shell with several cavities, much like bubble-wrap. The central cavity contains a semi-flexible glass fibre preform prepared using Tailored Fibre Placement method. The preform is either pre-impregnated with a light curable resin, or the resin is injected into the cavity during the surgical procedure, followed by light curing. The semi-flexible glass fibre preforms were also examined as separate devices, "miniplates". Two types of miniplates were scrutinized, a simplified pilot design and a spatially refined, "optimized" design. The optimized miniplates were implemented as biostable and bioresorbable versions. The feasibility of the in situ contourable composite implant system was demonstrated. The potential of Tailored Fibre Placement for the semi-flexible glass fibre preforms and miniplates was confirmed in a series of biomechanical tests. However, structural optimization is required. Antebrachial fractures in toy-breeds of dogs are exemplar veterinary applications of the devices; further applications in veterinary and human patients are foreseen.

Novel osteoconductive ß-tricalcium phosphate/poly(L-lactide-co-e-caprolactone) scaffold for bone regeneration: a study in a rabbit calvarial defect.

The advantages of synthetic bone graft substitutes over autogenous bone grafts include abundant graft volume, lack of complications related to the graft harvesting, and shorter operation and recovery times for the patient. We studied a new synthetic supercritical CO2 -processed porous composite scaffold of ß-tricalcium phosphate and poly(L-lactide-co-caprolactone) copolymer as a bone graft substitute in a rabbit calvarial defect. Bilateral 12 mm diameter critical size calvarial defects were successfully created in 18 rabbits. The right defect was filled with a scaffold moistened with bone marrow aspirate, and the other was an empty control. The material was assessed for applicability during surgery. The follow-up times were 4, 12, and 24 weeks. Radiographic and micro-CT studies and histopathological analysis were used to evaluate new bone formation, tissue ingrowth, and biocompatibility. The scaffold was easy to shape and handle during the surgery, and the bone-scaffold contact was tight when visually evaluated after the implantation. The material showed good biocompatibility and its porosity enabled rapid invasion of vasculature and full thickness mesenchymal tissue ingrowth already at four weeks. By 24 weeks, full thickness bone ingrowth within the scaffold and along the dura was generally seen. In contrast, the empty defect had only a thin layer of new bone at 24 weeks. The radiodensity of the material was similar to the density of the intact bone. In conclusion, the new porous scaffold material, composed of microgranular ß-TCP bound into the polymer matrix, proved to be a promising osteoconductive bone graft substitute with excellent handling properties.

Bioactive glass microspheres as osteopromotive inlays in macrotextured surfaces of Ti and CoCr alloy bone implants: trapezoidal surface grooves without inlay most efficient in resisting torsional forces.

We have tested the efficacy of porous bioactive glass (BG) inlays in enhancement of implant osseointegration. A total of 24 sheep underwent bilateral surgical implantation of three parallel implants on the anteromedial cortical surface of each tibia. The disc-shaped implants made of Ti6Al4V or cobalt chromium (CoCr) alloys had two parallel surface grooves (trapezoidal space with bottom widening) filled with sintered 100% bioactive glass microspheres or a selected mixture of bioactive and biocompatible glass microspheres. The surface of uncoated control implants was smooth, grit-blasted or had unfilled grooves. A subgroup of control smooth CoCr implants was coated with two or three BG layers. Implant incorporation with bone was evaluated using torque testing to failure, scanning electron microscopy and morphometry at 12 and 25 weeks. A total of 144 in vivo implants and 16 ex vivo cemented control implants were analyzed. Control Ti6Al4V implants with unfilled trapezoidal grooves showed highest torsional failure loads with excellent ingrowth of new bone and remodeling of ingrown bone into lamellar bone. Implants with BG inlays and microroughened control Ti6Al4V implants showed significantly lower torsional failure loads than control Ti6Al4V implants with unfilled grooves. In conclusion, BG inlays failed to enhance biological implant fixation. Macrotextured surface was more effective than grit-blasting in promotion of mechanical incorporation.

Bioceramic inlays do not improve mechanical incorporation of grit-blasted titanium stems in the proximal sheep femur.

The aim of the present study was to determine, if bioactive glass (BG) surface inlays improve osseointegration of titanium implants in the proximal femur of adult sheep. In simulation of uncemented primary stems (nine animals), only the proximal part of the implants was grit-blasted and three surface slots of the grit-blasted region were filled with sintered BG microspheres. Primary stems were implanted using press-fit technique. In revision stem simulation (eight animals), grit-blasting was extended over the whole implant and seven perforating holes of the stem were filled by sintered BG granules. Revision stems were implanted with a mixture of autogenous bone graft and BG granules. Comparison with solid partially or fully grit-blasted control stems implanted in the contralateral femurs was performed in the primary and revision stem experiments at 12 and 25 weeks, respectively. Implant incorporation was evaluated by torsional failure testing and histomorphometry. Only one-third of the primary stems anchored mechanically to bone. The revision stems incorporated better and the BG inlays of the revision stems showed ingrowth of new bone. However, there were no significant differences in the torsional failure loads between the stems with BG inlays and the control stems. In conclusion, surface BG inlays gave no measurable advantage in mechanical incorporation of grit-blasted titanium implants. Overall, the proximal sheep femur, characterized by minimal amount of cancellous bone and the presence of adipocytic bone marrow, seemed to present compromised bone healing conditions.