Abstract
Purposes of the study
To assess the performance of an acellular synthetic scaffold in the treatment of painful partial meniscal tissue loss.
Methods
Subjects recruited (n=52) had irreparable medial or lateral meniscus partial meniscus loss, intact rim, presence of both horns and a stable well aligned knee.
Diagnostic imaging was used to assess tissue ingrowth at 3 months post-implantation by evidence of vascularisation in the scaffold using DCE-MRI with intravenous gadolinium contrast material (n=42). All DCE-MRI scans were assessed centrally for neovascularisation in the peripheral half of the scaffold meniscus and integration of the implanted device. Stability of tissue ingrowth and cartilage scores in the index compartment were assessed at 12 and 24 months post-implantation using anatomic MRI scans.
Results
The 52 patients recruited (75% males) had a mean age of 30.8 ± 9.4 years and mean longitudinally measured lesions of 47.1 ± 10.0 mm, involving 34 medial and 18 lateral indications. At 3 months post-implantation tissue ingrowth was demonstrated in the peripheral half of the scaffold, in 36/42 (85.7%) subjects. To date stable or improved cartilage scores were seen in the index compartment at 12 months (n= 47) and 24 months (n=9). No signs of an inflammatory reaction to the scaffold or its degradation products were observed. The tissue observed on MRI at 12 months (n=47) remained stable at 24 months (n=9). No safety issues related to the scaffold were reported.
Conclusions
These preliminary results indicate that this novel scaffold induces ingrowth of stable tissue.
