The Groningen, Nijdam and Provox voice prostheses: a prospective clinical comparison based on 845 replacements.

The Groningen, Nijdam and Provox voice prostheses (VP) are all low-pressure, indwelling voice prostheses. Although there are differences concerning the valve mechanism, they have a similar design and are therefore interchangeable. In a prospective study, 845 consecutive replacements were evaluated in 158 patients. Average device lifetime differed significantly from 13 weeks for the Provox VP and 15.8 weeks for the Groningen VP, to 19 weeks for the Nijdam device. Leakage through or around a voice prosthesis was the main replacement indication. Leakage occurred significantly more often with the Provox VP (80.2%) than with the Groningen VP (58.8%) or the Nijdam VP (55%). Increased airflow resistance as a replacement indication occurred significantly more often with the Groningen VP (45.4%) and the Nijdam VP (45.9%) than with the Provox VP (22.7%). Complications during the replacement procedure were rare and usually mild. Replacement was usually an easy outpatient procedure; general anaesthesia was only necessary in 3.0% of 845 replacements, without any significant difference between the three devices. Granulation tissue and hypertrophic scar tissue formation were the most frequent local complications. They occurred in less than 10% of our patients but were significantly more common in patients with a Nijdam VP.

RCT Entities:   Population Interventions Outcomes