Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)

Recruiting

• Conditions: Hearing Loss; Bone Anchored Hearing Aids

• Registration Number: NCT06930781
• Lead Sponsor: Oticon Medical

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-08
• Study First Posted: 2025-04-16
• Status Verified: 2025-05
• Study Start: 2025-05-07
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-10-30
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• Adult subjects (≥18 years old) undergoing Ponto implantation in an out-of-OR setting from 2019 and onwards
• Signed informed consent (applicable for subjects answering questionnaires)

Exclusion Criteria

• No exclusion criteria have been set for this observational investigation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intraoperative complications at surgery	During the Ponto-implantation surgery

Secondary Outcome Measures

Name	Time	Method
To assess effectiveness of hearing rehabilitation using IOI-HA questionnaire	3 months after surgery	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.
To assess patient-reported benefit after BAHS treatment using the questionnaire Glasgow Benefit Inventory (GBI)	3 months after surgery	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.
Assessment of procedure room variables	12 months after study start	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'
To assess surgical parameters	During Ponto-implantation surgery	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.
Evaluation of patient experience of surgical procedure based on Ponto procedure questionnaire	5-10 days after Ponto surgery	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)
To assess postoperative events and complications	From day of surgery, through study completion, an average of 1 year	All postoperative events and complications will be presented in a descriptive table, listing how many were affected by each type of event or complication.
To assess rate of implant survival	3 months after surgery, and through study completion, an average of 1 year.	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.
To assess time from surgery to sound processor loading	Time from surgery to sound processor loading which happens at an average of 3 months after surgery.
To assess sound processor usage time	3 months after surgery, and through study completion, an average of 1 year.

Trial Locations

Locations (2)

Sunderby Sjukhus; 🇸🇪 Luleå, Norrbotten, Sweden

Skåne University Hospital; 🇸🇪 Lund, Skåne, Sweden