Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ponto implantation.
- Who it may be relevant to
- Registry conditions: Hearing Loss, Bone Anchored Hearing Aids. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Brazil, Canada, Spain, Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Ponto implantation
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.
Primary outcome measures
- Intraoperative complications at surgery [Time frame: During the Ponto-implantation surgery]
Secondary outcome measures (9)
- Assessment of procedure room variables [Time frame: 12 months after study start]
- To assess surgical parameters [Time frame: During Ponto-implantation surgery]
- Evaluation of patient experience of surgical procedure based on Ponto procedure questionnaire [Time frame: 5-10 days after Ponto surgery]
- To assess postoperative events and complications [Time frame: From day of surgery, through study completion, an average of 1 year]
- To assess rate of implant survival [Time frame: 3 months after surgery, and through study completion, an average of 1 year.]
- 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 [Time frame: 3 months after surgery]
- To assess patient-reported benefit after BAHS treatment using the questionnaire Glasgow Benefit Inventory (GBI) [Time frame: 3 months after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Sweden · 2 centers
- Sunderby Sjukhus — Luleå
- Skåne University Hospital — Lund
United States · 1 center
- Northern California Veterans Affairs Healthcare System — Sacramento
Brazil · 1 center
- Clinical Hospital from the Ribeirão Preto Medical School — São Paulo
Canada · 1 center
- Queen Elizabeth II Health Sciences Centre — Halifax
Spain · 1 center
- Hospital Virgen de las Nieves — Granada
Identifiers
NCT: NCT06930781 · BC118 · CIV-ID 25-01-051014