Successful osteoconduction but limited cartilage tissue quality following osteochondral repair by a cell-free multilayered nano-composite scaffold at the knee
Abstract:Osteochondral repair by implanting the MaioRegen® scaffold provides a successful osteoconduction and filling of the cartilage defect. However there is evidence for a limited repair cartilage tissue quality at 18 months after the surgery.
“…Perdisa et al [23] showed satisfactory clinical results at 60 months of follow-up, regardless of the defect size, suggesting the appropriateness of this procedure to treat also large OCD lesions. Nevertheless, MRI findings reported an incomplete bone regeneration, as reported also in other studies [24], demonstrating the difficulty to properly regenerate a physiologic subchondral bone tissue. To this regard, better results were proved for another procedure able of restoring the entire osteochondral unit in a single surgical procedure [22], the transplantation of fresh osteochondral allografts [25].…”
Purpose
To compare the results of two groups of patients affected by osteochondritis dissecans (OCD) of the knee and treated with either osteochondral autologous transplantation (OAT) or bone-cartilage paste grafting (PG).
Methods
A total of 27 patients affected by OCD lesions of the femoral condyles were included: 15 treated with OAT, 12 with PG, with comparable baseline characteristics (mean age 22.4 ± 7.2 vs. 24.2 ± 8.5 p = n.s., mean defect size 2.2 ± 1 cm2 vs 2.6 ± 1 cm2p = n.s.). Patients were evaluated pre-operatively and at 24 and 84 months post-operatively with the International Knee Documentation Committee (IKDC) subjective and objective scores. Sport activity level was evaluated with the Tegner activity score. Adverse events and failures were also recorded.
Results
The IKDC subjective score improved significantly in both groups. At 24 months, a significant improvement from 53.4 ± 9.1 to 80.8 ± 12.9 (p = 0.005) was obtained in the OAT group and from 44.6 ± 11.0 to 71.4 ± 25.3 in the PG group (p = 0.008). A further statistically significant increase was observed at 84 months in both groups. No significant differences were found between OAT and PG at both follow-ups. One OAT patient required post-operative knee mobilization under narcosis and two complained of donor site symptoms. More failures were documented in the PG vs OAT group (25% vs 0%; p = 0.043).
Conclusion
Both PG and OAT provided overall satisfactory results up to 84 months follow-up. However, while PG presents the advantages of a less invasive approach with lower adverse events, the higher failure rate of PG should be considered when choosing between these two surgical treatment options for restoration of the articular surface in patients affected by knee OCD.
“…Perdisa et al [23] showed satisfactory clinical results at 60 months of follow-up, regardless of the defect size, suggesting the appropriateness of this procedure to treat also large OCD lesions. Nevertheless, MRI findings reported an incomplete bone regeneration, as reported also in other studies [24], demonstrating the difficulty to properly regenerate a physiologic subchondral bone tissue. To this regard, better results were proved for another procedure able of restoring the entire osteochondral unit in a single surgical procedure [22], the transplantation of fresh osteochondral allografts [25].…”
Purpose
To compare the results of two groups of patients affected by osteochondritis dissecans (OCD) of the knee and treated with either osteochondral autologous transplantation (OAT) or bone-cartilage paste grafting (PG).
Methods
A total of 27 patients affected by OCD lesions of the femoral condyles were included: 15 treated with OAT, 12 with PG, with comparable baseline characteristics (mean age 22.4 ± 7.2 vs. 24.2 ± 8.5 p = n.s., mean defect size 2.2 ± 1 cm2 vs 2.6 ± 1 cm2p = n.s.). Patients were evaluated pre-operatively and at 24 and 84 months post-operatively with the International Knee Documentation Committee (IKDC) subjective and objective scores. Sport activity level was evaluated with the Tegner activity score. Adverse events and failures were also recorded.
Results
The IKDC subjective score improved significantly in both groups. At 24 months, a significant improvement from 53.4 ± 9.1 to 80.8 ± 12.9 (p = 0.005) was obtained in the OAT group and from 44.6 ± 11.0 to 71.4 ± 25.3 in the PG group (p = 0.008). A further statistically significant increase was observed at 84 months in both groups. No significant differences were found between OAT and PG at both follow-ups. One OAT patient required post-operative knee mobilization under narcosis and two complained of donor site symptoms. More failures were documented in the PG vs OAT group (25% vs 0%; p = 0.043).
Conclusion
Both PG and OAT provided overall satisfactory results up to 84 months follow-up. However, while PG presents the advantages of a less invasive approach with lower adverse events, the higher failure rate of PG should be considered when choosing between these two surgical treatment options for restoration of the articular surface in patients affected by knee OCD.
“…In this study, 2 patients were re-operated due to treatment failure and were excluded from the results. None of the patients showed a complete regeneration of the subchondral bone [119][120][121]…”
“…Since this report the clinical trials have been discontinued in Denmark and it is advised that MaioRegen be used with caution.Yan et al have examined the outcomes of clinical trials on 8 patients, and reported that subchondral edema, schlerosis and cyst were observed in most of the cases. A complete integration of the scaffold into the border zone was described; however, T2 mapping data and the zonal T2 index significantly differed in the repair tissue compared to the healthy control cartilage (P < 0.001) which indicates a limited quality of the repair cartilage obtained using this scaffold119 as observed inFigure 9.…”
Osteoarthritis (OA) is a degenerative joint disease, typified by degradation of cartilage and changes in the subchondral bone, resulting in pain, stiffness and reduced mobility. Current surgical treatments often fail to regenerate hyaline cartilage and result in the formation of fibrocartilage. Tissue engineering approaches have emerged for the repair of cartilage defects and damages to the subchondral bones in the early stage of OA and have shown potential in restoring the joint's function. In this approach, the use of three-dimensional scaffolds (with or without cells) provides support for tissue growth. Commercially available osteochondral (OC) scaffolds have been studied in OA patients for repair and regeneration of OC defects. However, some controversial results are often reported from both clinical trials and animal studies. The objective of this chapter is to report the scaffolds clinical requirements and performance of the currently available OC scaffolds that have been investigated both in animal studies and in clinical trials. The findings have demonstrated the importance of biological and biomechanical fixation of the OC scaffolds in achieving good cartilage fill and improved hyaline cartilage formation. It is concluded that improving cartilage fill, enhancing its integration with host tissues and achieving a strong and stable subchondral bone support for overlying cartilage are still grand challenges for the early treatment of OA.
“…5 a Volumetric bone mineral density (vBMD) of OA samples according to both cartilage grading and depth; b presence of a large cyst (white arrows) in an osteoarthritis sample (pQCT image) [ 84 ] and microCT image Fig. 6 a CT scan failed to show bone ingrowth ( arrow ) into TruFit plug [ 90 ]; b T2 mapping MRI scan of OC lesion repair after 18 months by the use of the MaioRegen scaffold, and bone cysts are observed [ 96 ]. With permissions from Elsevier and Springer Fig.…”
Section: Lessons From Clinical Osteochondral Scaffolds and What We Hamentioning
confidence: 99%
“… a CT scan failed to show bone ingrowth ( arrow ) into TruFit plug [ 90 ]; b T2 mapping MRI scan of OC lesion repair after 18 months by the use of the MaioRegen scaffold, and bone cysts are observed [ 96 ]. With permissions from Elsevier and Springer …”
Section: Lessons From Clinical Osteochondral Scaffolds and What We Hamentioning
Osteoarthritis (OA), identified as one of the priorities for the Bone and Joint Decade, is one of the most prevalent joint diseases, which causes pain and disability of joints in the adult population. Secondary OA usually stems from repetitive overloading to the osteochondral (OC) unit, which could result in cartilage damage and changes in the subchondral bone, leading to mechanical instability of the joint and loss of joint function. Tissue engineering approaches have emerged for the repair of cartilage defects and damages to the subchondral bone in the early stages of OA and have shown potential in restoring the joint’s function. In this approach, the use of three-dimensional scaffolds (with or without cells) provides support for tissue growth. Commercially available OC scaffolds have been studied in OA patients for repair and regeneration of OC defects. However, none of these scaffolds has shown satisfactory clinical results. This article reviews the OC tissue structure and the design, manufacturing and performance of current OC scaffolds in treatment of OA. The findings demonstrate the importance of biological and biomechanical fixations of OC scaffolds to the host tissue in achieving an improved cartilage fill and a hyaline-like tissue formation. Achieving a strong and stable subchondral bone support that helps the regeneration of overlying cartilage seems to be still a grand challenge for the early treatment of OA.
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