Objectives:
The aim of this study is to investigate and compare the clinical outcomes of minimally invasive ponto surgery (MIPS) to the linear incision technique with soft tissue preservation (LIT-TP) for percutaneous bone-anchored hearing implants (BAHI).
Study Design:
Prospective cohort study with a historical control group.
Setting:
Tertiary referral center.
Patients:
Twenty-five patients were prospectively included in the test group. The control group consisted of 25 patients who previously participated in another clinical trial and already underwent BAHI surgery.
Intervention:
All patients were implanted with a 4.5-mm-wide implant, using MIPS in the test group and the LIT-TP in the control group. Follow-up visits were scheduled 7 days, 21 days (sound processor fitting), 12 weeks and 6 months after surgery.
Main Outcome Measures:
The primary outcome measure was skin sensibility around the abutment 6 months after surgery. Secondary outcomes were subjective numbness, surgery time, wound healing, adverse soft tissue reactions, cosmetic outcomes, implant stability quotient (ISQ), implant survival, and sound processor use.
Results:
Skin sensibility, adverse soft tissue reactions, and sound processor use were comparable between groups. The test group had a shorter surgery time and better cosmetic outcomes. More skin dehiscences and a statistically nonsignificant higher implant loss rate (12% vs 0%, p = 0.079) were observed in the test group.
Conclusion:
MIPS is comparable to the LIT-TP regarding skin sensibility at 6 months and soft tissue tolerability. With MIPS, surgery time is further reduced and better cosmetic outcomes are reported. More research into MIPS, exact drill protocol, used instruments, and associated implant loss is warranted.
Objective:To compare 3-year implant stability, survival, and tolerability of a 4.5-mm-wide (test) and a 3.75-mm-wide (control) percutaneous titanium implant for bone-conduction hearing, loaded with the sound processor after 3 weeks.Methods:Sixty implants were allocated in a 2:1 ratio (test-control) in 57 adult patients included in this prospective randomized controlled clinical trial. Follow-up visits were performed at 7, 14, 21, and 28 days; 6 and 12 weeks; 6 months; and at 1, 2, and 3 years after implantation. During these visits, the implant stability quotient (ISQ) was measured by means of resonance frequency analysis (RFA). The peri-abutment soft tissue status was assessed according to the Holgers classification. Skin height around the abutment was evaluated.Results:The mean area-under-the-curve (AUC) of ISQ-low was statistically significantly higher for the test implant (65.7 versus 61.4, p = 0.0002). Both implants showed high survival rates (97.4% versus 95.0%, p = 0.6374). Adverse soft tissue reactions were observed sporadically, with no significant inter-group differences. Skin thickening was seen in the majority of the patients, but no correlation with adverse soft tissue reactions or implant type was observed.Conclusion:The 4.5-mm-wide implant provides significantly higher ISQ values during the first 3 years after surgery compared with the previous generation 3.75-mm-wide implant. Both implants showed high survival rates and good tolerability. These long-term results indicate that the wider implant, loaded with a sound processor at 3 weeks, is a safe and well-performing option for hearing rehabilitation in specific types of hearing loss.
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