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

Mixed Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807713
• Other study ID #: C69
• Status: Completed
• Phase: N/A
• Start date: September 7, 2018
• Est. completion date: March 29, 2022

Study information

• Verified date: March 2021
• Source: Oticon Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 29, 2022
• Est. primary completion date: November 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bone Conduction Deafness
• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Hearing Loss, Mixed Conductive-Sensorineural
• Hearing Loss, Unilateral
• Middle Ear Deafness
• Mixed Hearing Loss
• Unilateral Deafness

Intervention

Device:
• Minimally Invasive Ponto Surgery
Minimally Invasive Ponto surgery is used for hearing rehabilitation using Ponto Wide Implants in patients indicated and counselled for Bone Anchored Hearing Systems.

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Center	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Oticon Medical

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbness (sensibility) around the implant	Total numbness around the implant will be assessed as a combination of gnostic and vital sensibility.	6 months post surgery
Secondary	Length of surgery	Compare the surgical time between test (this investigation) and control group (previous investigation, C47).	At surgery
Secondary	Unplanned visits	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).	36 months
Secondary	Adverse skin reactions	Investigate and compare the rate of adverse skin reactions using the Holgers Scale.	36 months
Secondary	Adverse skin reactions	Investigate and compare the rate of adverse skin reactions using the IPS scale.	36 months
Secondary	Pain perception by patient	Investigate and compare pain using a visual analogue scale 0-10	36 months
Secondary	Implant survivability	Investigate and compare implant survivability in terms of reported implant loss.	36 months
Secondary	Implant stability as measured with resonance frequency analysis, RFA.	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).	36 months
Secondary	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 and record any medications that were given to aid in skin healing.	36 months
Secondary	Wound dehiscence	Investigate wound dehiscence size after surgery.	36 months
Secondary	Quality of Life Assessment	Investigate and compare subjective benefit as measured by SSQ questionnaire.	36 months
Secondary	Quality of Life Assessment	Investigate and compare subjective benefit as measured by YORK questionnaire.	36 months
Secondary	Quality of Life Assessment	Investigate and compare subjective benefit as measured by APHAB questionnaire.	36 months
Secondary	Quality of Life Assessment	Investigate and compare subjective benefit as measured by GBI questionnaire.	36 months
Secondary	Quality of Life Assessment	Investigate and compare subjective benefit as measured by GHSI questionnaire.	36 months