Minimally Invasive Ponto Surgery Versus the Linear Incision Technique With Soft Tissue Preservation for Bone Conduction Hearing Implants: A Multicenter Randomized Controlled Trial.
Otol Neurotol
; 39(7): 882-893, 2018 08.
Article
en En
| MEDLINE
| ID: mdl-29995008
ABSTRACT
OBJECTIVE:
To compare the surgical outcomes of the Minimally Invasive Ponto Surgery (MIPS) technique with those of the linear incision technique with soft-tissue preservation for bone-anchored hearing systems (BAHS).DESIGN:
Sponsor-initiated multicenter, open, randomized, controlled clinical trial.SETTING:
Maastricht University Medical Centre, Ziekenhuisgroep Twente and Medisch Centrum Leeuwarden, all situated in The Netherlands.PARTICIPANTS:
Sixty-four adult patients eligible for unilateral BAHS surgery.Interventions Single-stage BAHS surgery with 11 randomization to the linear incision technique with soft-tissue preservation (control) or the MIPS (test) group. PRIMARY AND SECONDARY OUTCOME MEASUREMENTS Primaryobjective:
compare the incidence of inflammation (Holgers Index ≥ 2) during 12 weeks' follow-up after surgery. Secondaryobjectives:
skin dehiscence, pain scores, loss of sensibility around the implant, soft-tissue overgrowth, skin sagging, implant extrusion, cosmetic results, surgical time, wound healing and Implant Stability Quotient measurements.RESULTS:
Sixty-three subjects were analyzed in the intention-to-treat population. No significant difference was found for the incidence of inflammation between groups. Loss of skin sensibility, cosmetic outcomes, skin sagging, and surgical time were significantly better in the test group. No statistically significant differences were found for dehiscence, pain, and soft-tissue overgrowth. A nonsignificant difference in extrusion was found for the test group. The Implant Stability Quotient was statistically influenced by the surgical technique, abutment length, and time.CONCLUSION:
No significant differences between the MIPS and the linear incision techniques were observed regarding skin inflammation. MIPS results in a statistically significant reduction in the loss of skin sensibility, less skin sagging, improved cosmetic results, and reduced surgical time. Although nonsignificant, the implant extrusion rate warrants further research.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Conducción Ósea
/
Implantes Cocleares
/
Procedimientos Quirúrgicos Mínimamente Invasivos
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Implantación Coclear
/
Tratamientos Conservadores del Órgano
Tipo de estudio:
Clinical_trials
Límite:
Adolescent
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Adult
/
Female
/
Humans
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Male
/
Middle aged
Idioma:
En
Revista:
Otol Neurotol
Asunto de la revista:
NEUROLOGIA
/
OTORRINOLARINGOLOGIA
Año:
2018
Tipo del documento:
Article
País de afiliación:
Países Bajos