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

Oticon Medical1 site in 1 country25 target enrollmentSeptember 7, 2018

ConditionsBone Conduction Deafness Unilateral Deafness Middle Ear Deafness Mixed Hearing Loss

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bone Conduction Deafness
Sponsor: Oticon Medical
Enrollment: 25
Locations: 1
Primary Endpoint: Numbness (sensibility) around the implant
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 7, 2018

End Date

March 29, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Oticon Medical

Responsible Party

Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Numbness (sensibility) around the implant

Time Frame: 6 months post surgery

Total numbness around the implant will be assessed as a combination of gnostic and vital sensibility.

Secondary Outcomes

Wound dehiscence(36 months)
Implant stability as measured with resonance frequency analysis, RFA.(36 months)
Quality of Life Assessment(36 months)
Implant survivability(36 months)
Surgical wound healing time(36 months)
Length of surgery(At surgery)
Pain perception by patient(36 months)
Adverse skin reactions(36 months)
Unplanned visits(36 months)