An interventional study of Minimally Invasive Ponto Surgery in Bone Conduction Deafness, Unilateral Deafness and Middle Ear Deafness, sponsored by Oticon Medical. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-03.
Sponsored by Oticon Medical · Not applicable, Interventional, and Treatment
The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and abutments.
Exclusion Criteria:
Surgical method for installation of a bone anchored hearing system for hearing rehabilitation
Device: Minimally Invasive Ponto Surgery
Minimally Invasive Ponto surgery is used for hearing rehabilitation using Ponto Wide Implant in patients indicated and counselled for Bone Anchored Hearing System.
Numbness (sensibility) around surgery area
The primary objective of the study is to investigate the difference in numbness around implant after MIPS procedure (test, this investigation) and a surgery with soft tissue preservation (control, from a previous study, C47) for implanting Oticon Medical implants and abutments. Two different sensibilities will be tested by means of a broken wooden cotton swab/bud (q-tip): gnostic (with cotton side) and vital (with broken, sharp wooden side) sensibility. The measurement locations will be standardized at specific positions from surgery location, and the same location (with respect to the surgery site) will be used for sensibility measurement for each patient visit. Both the area (diameter in cm) and the degree (scale form 0 (no complaints) to 10 (maximum complaints)) will be monitored. Additionally, patients' subjective sensibility judgment around surgery area on a scale of 0-10 will be recorded.
Time frame: 6 months post surgery
Time needed for surgery
Compare the surgical time between test (this investigation) and control group (previous investigation, C47).
Time frame: At surgery
Unplanned visit
Investigate and compare the number of unplanned visits, unplanned surgical procedures and other treatments for the test (this investigation) and control group (previous investigation, C47).
Time frame: 36 months
Adverse Events
Investigate and compare the rate of adverse skin reactions using the Holgers Scale and the IPS scale.
Time frame: 36 months
Pain perception by patient
Investigate and compare patient perceived pain. For pain measurement, the patient is asked if pain around the implant is present. If it's present, duration is assessed (more or less than 6 weeks present). In addition, increase of pain is assessed during manipulation of the abutment (tightening of or tapping on the abutment). The patient is asked to score the perceived pain on a scale of 0-10; with 0 being no pain at all and 10 being the highest pain the patient had ever experienced.
Time frame: 36 months
Implant survivability
Investigate and compare implant survivability. Implant survivability is monitored by following upon patients and recording implant losses if and when they occur. The investigators do not expect multiple patients to have an implant loss. However, this may happen due to different reasons. The investigators would track the circumstances under which the implant loss occurred and the time between implant installation and loss.
Time frame: 36 months
Implant stability as measures by Implant stability quotient.
Investigate implant stability.
Time frame: 36 months
Surgical wound healing time
Investigate and compare healing time after surgery. Follow-up visits after surgery will assess the healing of wound. This will be a yes/no assessment to be answered by the attending physician. The investigators will also evaluate skin reactions using the Holgers Scoring Scheme and record any medications that were given to aid in skin healing.
Time frame: 36 months
Quality of Life Assessment
Investigate and compare subjective benefit as measured by APHAB, GBI and GHSI questionnaires.
Time frame: 36 months
Aesthetic Assessment
Investigate and compare scar assessment by surgeon and patient (POSAS).
Time frame: 36 months
Plan to share: No
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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