Clinical trial NCT04279236: Multi-Center Study on Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (in Adult Patients)
Official title: A Prospective Multi-Center Study on the Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (MIPS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2020-02-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to participating clinics who meet clinical indications for surgical intervention with a bone anchored hearing system.

Brief summary: This prospective, multi-center study funded by Oticon Medical AB will be conducted at six clinical sites in North America. Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. The total number of participants included in the study will be 64.

The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Implant system using the surgical technique Minimally Invasive Ponto Surgery (MIPS).

Detailed description: This prospective, multi-centre study funded by Oticon Medical AB will be conducted at six clinical sites in North America. Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. The total number of participants included in the study will be 64. Patients who are withdrawn from the study prior to completion will not be replaced.

The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Implant system using the surgical technique Minimally Invasive Ponto Surgery (MIPS). The implant, coupled to a skin-penetrating abutment, is implanted in the bone behind the ear and is later loaded with a sound processor which transforms sound waves to sound vibrations that can be sent directly to the inner ear via the skull bone. The primary objective of this study is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for a sound processor, 3 months after implantation/surgery.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Patient indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines.
* Normal bone quality and bone thickness above 3 mm, where no complications during surgery are expected.
* Skin thickness of 12mm or less at the implant site

Exclusion Criteria:

* Patients undergoing re-implantation
* Patients who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales.
* Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus
* Known conditions (e.g. uncontrolled diabetes) that could jeopardize skin condition and wound healing over time as judged by the investigator.
* Any other known condition that the investigator determines could interfere with compliance or study assessments.

Primary outcomes:
measure: Implant/abutment complex capability to provide reliable anchorage for sound processor
timeFrame: 3 months after implant surgery (MIPS)
Secondary outcomes:
measure: Implant/abutment complex capability to provide reliable anchorage for sound processor
timeFrame: 12 months after implant surgery (MIPS)
measure: Implant survival
timeFrame: 12 months after implant surgery (MIPS)
measure: Implant stability
timeFrame: 12 months after implant surgery (MIPS)
measure: Holgers score ratings
timeFrame: 12 months after implant surgery (MIPS)
measure: IPS scores
timeFrame: 12 months after implant surgery (MIPS)
measure: Patient-perceived presence of pain around implant/abutment
timeFrame: 12 months after implant surgery (MIPS)
measure: Patient-perceived magnitude of pain around implant/abutment
timeFrame: 12 months after implant surgery (MIPS)
measure: Patient-perceived presence of numbness around implant/abutment
timeFrame: 12 months after implant surgery (MIPS)
measure: Patient-perceived magnitude of numbness around implant/abutment
timeFrame: 12 months after implant surgery (MIPS)
measure: Skin/soft tissue overgrowth
timeFrame: 12 months after implant surgery (MIPS)
measure: Duration of surgery
timeFrame: At implant surgery (MIPS)
measure: Wound dehiscence
timeFrame: 12 months after implant surgery (MIPS)
measure: Wound healing time
timeFrame: 12 months after implant surgery (MIPS)
measure: Implant/abutment usage
timeFrame: 12 months after implant surgery (MIPS)
measure: Subjective benefit after MIPS surgery
timeFrame: At screening visit (visit before surgery)
measure: Subjective benefit after MIPS surgery
timeFrame: 6 months after implant surgery (MIPS)
measure: Subjective benefit after MIPS surgery
timeFrame: 3 months after implant surgery (MIPS)
measure: Subjective benefit after MIPS surgery
timeFrame: 12 months after implant surgery (MIPS)
Other outcomes:
measure: Safety outcome
timeFrame: 12 months after implant surgery (MIPS)
Locations:
city: Sarasota
country: United States
facility: Silverstein Institute
state: Florida
city: Indianapolis
country: United States
facility: Otolaryngology Associates
state: Indiana
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
city: Portland
country: United States
facility: Northwest Ear Institute
state: Oregon
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Montreal
country: Canada
facility: The Research Institute of the McGill University Health Centre
state: Quebec
city: San Sebastián
country: Spain
facility: Hospital Universitario de Donostia
state: Gipuzkoa
Study officials:
References: