This study is a combined retro- and prospective, single arm, multicentre investigation designed to follow clinical practice for Ponto-implantations performed out of OR. The overall objective is to investigate the complication rate for procedures performed out-of-OR.
The study is observational and non interventional and follows clinical practice at participating clinics with the only exception of three questionnaires given to consenting patients after surgery and during follow-up, after loading of the sound processor. The study is a combined retro- and prospective study. The retrospective part consists of a chart review of patients who have undergone Ponto-implantation out of OR from 2019 and onwards. The prospectively recruited subjects are patients who are planned to undergo Ponto-implantation surgery out-of-OR.
Study Type
OBSERVATIONAL
Enrollment
270
Ponto implantation is a surgical procedure to implant a bone-anchored hearing device, improving hearing by transmitting sound directly to the inner ear through bone conduction.
Sunderby Sjukhus
Luleå, Norrbotten County, Sweden
RECRUITINGSkåne University Hospital
Lund, Skåne County, Sweden
RECRUITINGIntraoperative complications at surgery
Time frame: During the Ponto-implantation surgery
Assessment of procedure room variables
To make an assessment of how procedure rooms that are used for Ponto out-of-OR surgeries look like. Will be measured using the 'Procedure room used for Out-of-OR Ponto-surgery questionnaire'
Time frame: 12 months after study start
To assess surgical parameters
With this outcome, the aim is to assess the surgical variables present during Ponto out-of-OR surgeries. A series of yes or no questions will be presented in a form to the surgeon regarding the use of anesthesia, sedatives, implants, and abutments of different lengths. The results will be presented in a table.
Time frame: During Ponto-implantation surgery
Evaluation of patient experience of surgical procedure based on Ponto procedure questionnaire
Score is reported on a scale of 5 steps, were the lowest value (1) is the worst and the highest value is the best (5)
Time frame: 5-10 days after Ponto surgery
To assess postoperative events and complications
All postoperative events and complications will be presented in a descriptive table, listing how many were affected by each type of event or complication.
Time frame: From day of surgery, through study completion, an average of 1 year
To assess rate of implant survival
Implant survival will be assessed at least once, at 3 months. If follow-up data is available, implant survival will be assessed through study completion, an average of 1 year.
Time frame: 3 months after surgery, and through study completion, an average of 1 year.
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To assess time from surgery to sound processor loading
Time frame: Time from surgery to sound processor loading which happens at an average of 3 months after surgery.
To assess sound processor usage time
Time frame: 3 months after surgery, and through study completion, an average of 1 year.
To assess effectiveness of hearing rehabilitation using IOI-HA questionnaire
Will be assessed using the standardised questionnaire International Outcome Inventory for Hearing Aids (IOI-HA) score at 3 months post-surgery. In the questionnaire, each item has five response choices proceeding from the worst outcome to the best outcome (1-5). The score will be presented as mean score with, standard deviation and median for the two groups.
Time frame: 3 months after surgery
To assess patient-reported benefit after BAHS treatment using the questionnaire Glasgow Benefit Inventory (GBI)
Glasgow Benefit Inventory (GBI) benefit scores will be presented for total-, general-, social- and physical scores at 3 months post-surgery. The GBI uses a scale from -100 to +100, where scores above 0 indicate improved quality of life.
Time frame: 3 months after surgery