Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration

Not Applicable

Completed

• Conditions: Middle Ear Deafness; Unilateral Deafness; Mixed Hearing Loss; Bone Conduction Deafness
• Interventions: Device: Minimally Invasive Ponto Surgery

• Registration Number: NCT03807713
• Lead Sponsor: Oticon Medical

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-07
• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-17
• Primary Completion: 2019-11-06
• Status Verified: 2021-03
• Study Completion: 2022-03-29
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• 18 years or older.
• Patient indicated for an ear level bone anchored sound processor.
• Healthy bone quality to allow for 4mm implant insertion.

Exclusion Criteria

• Intraoperative switch to an alternative surgical technique
• Patients undergoing re-implantation (on the side being included in the study)
• Previous participation in the C47 study.
• Inability to participate in follow-up.
• Psychiatric disease in the medical history.
• Mental disability.
• Presumed doubt, for any reason, that the patient will be able to show up on all follow-ups.
• Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
• Patients with natural skin height of >12mm (as there will be additional skin reduction needed)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Minimally Invasive Ponto Surgery	Minimally Invasive Ponto Surgery	Surgical method for installation of a bone anchored hearing system for hearing rehabilitation

Primary Outcome Measures

Name	Time	Method
Numbness (sensibility) around the implant	6 months post surgery	Total numbness around the implant will be assessed as a combination of gnostic and vital sensibility.

Secondary Outcome Measures

Name	Time	Method
Implant stability as measured with resonance frequency analysis, RFA.	36 months	Investigate and compare implant stability.; Implant stability is monitored by measuring the implant stability quotient when following up on patients. Stability will be reported as implant stability quotient (ISQ).
Wound dehiscence	36 months	Investigate wound dehiscence size after surgery.
Quality of Life Assessment	36 months	Investigate and compare subjective benefit as measured by GHSI questionnaire.
Implant survivability	36 months	Investigate and compare implant survivability in terms of reported implant loss.
Surgical wound healing time	36 months	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 and record any medications that were given to aid in skin healing.
Length of surgery	At surgery	Compare the surgical time between test (this investigation) and control group (previous investigation, C47).
Pain perception by patient	36 months	Investigate and compare pain using a visual analogue scale 0-10
Adverse skin reactions	36 months	Investigate and compare the rate of adverse skin reactions using the IPS scale.
Unplanned visits	36 months	Investigate and compare the number of unplanned visits, including unplanned surgical procedures and other treatments for the test (this investigation) and control group (previous investigation, C47).

Trial Locations

Locations (1)

Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands