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DOI: 10.1055/s-0040-1712865
Evaluation of a Novel, Resorbable Interference Screw for CrCL Reconstruction
Publication History
Publication Date:
21 May 2020 (online)
Introduction: Soft tissue fixation screws are used commonly in orthopaedics. Metallic and current polymeric–bioceramic composite materials each have disadvantages. We hypothesized that a novel POC/HA composite (Citregen) interference screw would provide comparable soft tissue fixation to a predicate polymeric/bioceramic screw in an ovine CrCL replacement model.
Materials and Methods: CrCL replacement was performed in 24 mature female sheep using a lateral digital extensor (LDE) tendon graft. Interference screws securing the LDE graft in femoral and tibial tunnels included novel Citregen tendon interference screws (CTIS) and predicate PLDLA-βTCP screws (control). Animals were sacrificed at 3 and 6 months (biomechanics: n = 6 specimens/group and histology: n = 6 specimens/group), and 12 months (histology: n = 3 CTIS specimens). Contralateral limbs were used for time-0 biomechanical evaluation of CTIS, control, and an additional Citregen implant (Citrelock Screw [CLS]). Outcome parameters were statistically compared using one-way (time 0) and two-way ANOVA (animal study outcomes) with an α-value of 0.05.
Results: No statistical differences (CTIS vs. control) in biomechanical outcomes were observed at 0, 3, or 6 months or in histomorphometric analysis at 0 or 3 months. Soft tissue volume was greater around CTIS (vs. control) at 6 months (p = 0.001). CTIS showed significantly more tendon remodelling (p < 0.001) and trending towards greater amounts of bone (p = 0.115) in 12-month specimens (vs. time 0). CLS screws demonstrated significantly greater baseline yield/ultimate force and stress (vs. control and CTIS).
Discussion/Conclusion: The novel, resorbable, citrate-based CTIS provided comparable mechanical characteristics and increased soft tissue and bone formation relative to the predicate interference screw.
Acknowledgment: Funded by Acuitive Technologies.
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No conflict of interest has been declared by the author(s).