Orbital Floor Reconstruction: A Comparison of Outcomes between Absorbable and Permanent Implant Systems

There are distinct advantages and disadvantages between bioresorbable and permanent implants in orbital floor reconstruction. Our aim was to compare the outcomes and complications of resorbable implants and permanent implants in orbital floor fracture repair. A retrospective chart review was performed on all patients who underwent orbital floor fracture repair at a rural, tertiary care center from 2011 through 2016. Main outcome measures included improvement in diplopia, ocular motility, enophthalmos, hypoglobus, and infraorbital nerve sensation. A total of 87 patients underwent orbital floor reconstruction. After exclusion criteria were applied, 22 patients were included in the absorbable implant cohort, and 20 patients in the nonabsorbable implant cohort. All absorbable implants were composed of poly L-lactide/poly glycolide/poly D-lactide (PLL/PG/PDL), and nonabsorbable implants included both titanium/porous polyethylene (Ti/PPE) composite and titanium (Ti) mesh. Mean fracture surface area was 2.1 cm2 (standard deviation [SD]:± 0.9 cm2, range: 0.4–3.6 cm2) for the absorbable implant group and 2.3 cm2 (SD: ± 1.1 cm2, range: 0.6–4.4 cm2) for the nonabsorbable implant group ( p = 0.58). There were no significant differences in diplopia, ocular motility, enophthalmos, hypoglobus, and infraorbital nerve sensation between absorbable and nonabsorbable implant groups. The mean follow-up time for absorbable and nonabsorbable implant groups was 622 (SD ± 313) and 578 (SD ± 151) days respectively ( p = 0.57). For moderate-size orbital floor fracture repairs, there is no difference in outcomes between absorbable implants consisting of PLL/PG/PDL and nonabsorbable implants consisting of Ti mesh or Ti/PPE combination.

A 2-Year Follow-up Study of an Absorbable Implant to Treat Nasal Valve Collapse

The safety and effectiveness of an absorbable implant for lateral cartilage support have been recently demonstrated in subjects with nasal valve collapse (NVC) at 12 months postprocedure. This follow-up study aimed to assess whether the safety and effectiveness of the implant persist in these patients for 24 months after the procedure. Thirty subjects with Nasal Obstruction Symptom Evaluation (NOSE) score ≥ 55 and isolated NVC were treated; 14 cases were performed in an operating suite under general anesthesia and 16 cases were performed in a clinic-based setting under local anesthesia. The implant, a polylactic acid copolymer, was placed with a delivery tool within the nasal wall to provide lateral cartilage support. Subjects were followed up through 24 months postprocedure. Fifty-six implants were placed in 30 subjects. The mean preoperative NOSE score was 76.7 ± 14.8, with a range of 55 to 100. At 24 months, the mean score was 32.0 ± 29.3, reflecting an average within-patient reduction of −44.0 ± 31.1 points. There were no device-related adverse events in the 12 to 24 months period. There were five subjects who exited the study prior to the 24-month follow-up. Four of the five subjects who exited were elected for further intervention and one subject was lost to follow-up. This study demonstrates safety of an absorbable implant for lateral nasal wall support and symptom improvement in some subjects with NVC at 24 months postprocedure.

Absorbable Implant to Treat Nasal Valve Collapse

Objective To evaluate the safety and effectiveness of an absorbable implant for lateral cartilage support in subjects with nasal valve collapse (NVC) with 12 months follow-up. Methods Thirty subjects with Nasal Obstruction Symptom Evaluation (NOSE) score ≥ 55 and isolated NVC were treated; 14 cases were performed in an operating suite under general anesthesia and 16 cases were performed in a clinic-based setting under local anesthesia. The implant, a polylactic acid copolymer, was placed with a delivery tool within the nasal wall to provide lateral cartilage support. Subjects were followed up through 12 months postprocedure. Results Fifty-six implants were placed in 30 subjects. The mean preoperative NOSE score was 76.7 ± 14.8, with a range of 55 to 100. At 12 months, the mean score was 35.2 ± 29.2, reflecting an average within-patient reduction of –40.9 ± 31.2 points. The majority (76%) of the subjects were responders defined as having at least one NOSE class improvement or a NOSE score reduction of at least 20%. There were no adverse changes in cosmetic appearance at 12 months postprocedure. Three implants in three subjects required retrieval within 30 days postprocedure and resulted in no clinical sequelae. Conclusion This study demonstrates safety and effectiveness of an absorbable implant for lateral cartilage support in subjects with NVC at 12 months postprocedure.