Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)

Mixed Hearing Loss Clinical Trial

Official title:

Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03281967
• Other study ID #: C63
• Status: Completed
• Phase: N/A
• Start date: June 9, 2017
• Est. completion date: December 21, 2020

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: December 21, 2020
• Est. primary completion date: June 13, 2018
• 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 Implant in patients indicated and counselled for Bone Anchored Hearing System.

Locations

Country	Name	City	State
Netherlands	University Medical Center St Radboud	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 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.	6 months post surgery
Secondary	Time needed for surgery	Compare the surgical time between test (this investigation) and control group (previous investigation, C47).	At surgery
Secondary	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).	36 months
Secondary	Adverse Events	Investigate and compare the rate of adverse skin reactions using the Holgers Scale and the IPS scale.	36 months
Secondary	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.	36 months
Secondary	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.	36 months
Secondary	Implant stability as measures by Implant stability quotient.	Investigate implant stability.	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 using the Holgers Scoring Scheme and record any medications that were given to aid in skin healing.	36 months
Secondary	Quality of Life Assessment	Investigate and compare subjective benefit as measured by APHAB, GBI and GHSI questionnaires.	36 months
Secondary	Aesthetic Assessment	Investigate and compare scar assessment by surgeon and patient (POSAS).	36 months