The challenge of implant integration in partial meniscal replacement: an experimental study on a silk fibroin scaffold in sheep.

PURPOSE: To restore meniscal function after excessive tissue damage, a silk fibroin implant for partial meniscal replacement was developed and investigated in an earlier sheep model. After 6 months implantation, it showed promising results in terms of chondroprotection and biocompatibility. To improve surgical fixation, the material was subjected to optimisation and a fibre mesh was integrated into the porous matrix. The aim of the study was the evaluation of this second generation of silk fibroin implants in a sheep model. METHODS: Nine adult merino sheep received subtotal meniscal replacement using the silk fibroin scaffold. In nine additional animals, the defect was left untreated. Sham surgery was performed in another group of nine animals. After 6 months of implantation macroscopic, biomechanical and histological evaluations of the scaffold, meniscus, and articular cartilage were conducted. RESULTS: Macroscopic evaluation revealed no signs of inflammation of the operated knee joint and most implants were located in the defect. However, there was no solid connection to the remaining peripheral meniscal rim and three devices showed a radial rupture at the middle zone. The equilibrium modulus of the scaffold increased after 6 months implantation time as identified by biomechanical testing (before implantation 0.6 ± 0.3 MPa; after implantation: 0.8 ± 0.3 MPa). Macroscopically and histologically visible softening and fibrillation of the articular cartilage in the meniscectomy- and implant group were confirmed biomechanically by indentation testing of the tibial cartilage. CONCLUSIONS: In the current study, biocompatibility of the silk fibroin scaffold was reconfirmed. The initial mechanical properties of the silk fibroin implant resembled native meniscal tissue. However, stiffness of the scaffold increased considerably after implantation. This might have prevented integration of the device and chondroprotection of the underlying cartilage. Furthermore, the increased stiffness of the material is likely responsible for the partial destruction of some implants. Clinically, we learn that an inappropriate replacement device might lead to similar cartilage damage as seen after meniscectomy. Given the poor acceptance of the clinically available partial meniscal replacement devices, it can be speculated that development of a total meniscal replacement device might be the less challenging option.

Delayed bone healing following high tibial osteotomy related to increased implant stiffness in locked plating.

INTRODUCTION: Asymmetrical callus formation and incomplete bone formation underneath stiff locking plates have been reported recently in clinical and experimental fracture healing studies. After similar effects were observed in the outcome of high tibial osteotomy (HTO) patients, a retrospective study was performed to quantify the frequency and level of such incomplete healing cases. MATERIAL AND METHODS: Twenty-three patients treated with medial open wedge HTO and locking plate (Tomofix™) for posttraumatic or congenital genu varum were investigated. No bone grafts were applied to fill the osteotomy gap. The median correction angle was 8° (5-18°). Elective hardware removal was performed after a median of 19.5 months (12-58 months) following an uneventful clinical course. The most recent postoperative X-ray available (median 21 months; 13-56 months) was evaluated for consolidation of the osteotomy. We performed an in vitro biomechanical experiment using the same HTO on a loaded cadaver knee joint to compare interfragmentary movements (IFMs) when using regular locking screws with the Tomofix™ plate and screws that enabled dynamic stabilisation of this plate. RESULTS: Fifteen patients (65%) displayed incomplete consolidation of the osteotomy underneath the locking plate (10.9% of the osteotomy length) and cortical deficiency. The time to implant removal for these patients of 27 months was longer than the 21 months for the patients with a complete osteotomy gap healing. The biomechanical experiment demonstrated that very low IFMs and corresponding interfragmentary strain occur underneath the plate when using regular locking screws. Replacement with dynamic screws resulted in an increased IFM. DISCUSSION AND CONCLUSIONS: These results support the hypothesis that low bone formation underneath locking plates is induced by increased stiffness. This high stiffness situation could be altered by replacing the standard screws with dynamic screws which allow for a movement of 0.35mm perpendicular to the screw axis. This resulted in an approximately threefold increase in the IFM and may be a potential concept to avoid incomplete bone healing under stiff plate fixations.

Differences of bone healing in metaphyseal defect fractures between osteoporotic and physiological bone in rats.

Discrepancies in bone healing between osteoporotic and non-osteoporotic bone remain uncertain. The focus of the current work is to evaluate potential healing discrepancies in a metaphyseal defect model in rat femora. Female Sprague-Dawley rats were either ovariectomized (OVX, n=14) and combined with a calcium-, phosphorus- and vitamin D3-, soy- and phytoestrogen-free diet or received SHAM operation with standard diet rat (SHAM, n=14). Three months post-ovariectomy, DEXA measurement showed a reduction of bone mineral density reflecting an osteoporotic bone status in OVX rats. Rats then underwent a 3 mm wedge-shaped osteotomy at the distal metaphyseal area of the left femur stabilized with a T-shaped mini-plate and allowed to heal for 6 weeks. Biomechanical competence by means of a non-destructive three-point bending test showed significant lower flexural rigidity in the OVX rats at 3 mm lever span compared to SHAM animals (p=0.048) but no differences at 10 mm lever span. Microcomputer tomography (µCT) showed bridging cortices and consolidation of the defect in both groups, however, no measurable differences were found in either total ossified tissue or vascular volume fraction. Furthermore, histology showed healing discrepancies that were characterized by cartilaginous remnant and more unmineralized tissue presence in the OVX rats compared to more mature consolidation appearance in the SHAM group. In summary, bone defect healing in metaphyseal bone slightly differs between osteoporotic and non-osteoporotic bone in the current 3 mm defect model in both 3mm lever span biomechanical testing and histology.

Strain hardening of fascia: static stretching of dense fibrous connective tissues can induce a temporary stiffness increase accompanied by enhanced matrix hydration.

This study examined a potential cellular basis for strain hardening of fascial tissues: an increase in stiffness induced by stretch and subsequent rest. Mice lumbodorsal fascia were isometrically stretched for 15 min followed by 30 min rest (n=16). An increase in stiffness was observed in the majority of samples, including the nonviable control samples. Investigations with porcine lumbar fascia explored hydration changes as an explanation (n=24). Subject to similar loading procedures, tissues showed decreases in fluid content immediately post-stretch and increases during rest phases. When allowed sufficient resting time, a super-compensation phenomenon was observed, characterised by matrix hydration higher than initial levels and increases in tissue stiffness. Therefore, fascial strain hardening does not seem to rely on cellular contraction, but rather on this super-compensation. Given a comparable occurrence of this behaviour in vivo, clinical application of routines for injury prevention merit exploration.