Clinical trial NCT04606823: Ponto Implantation Using a Minimally Invasive Surgical Technique
Official title: Evaluation of Clinical Performance of Ponto Implantation Using a Minimally Invasive Surgical Technique - a Prospective Multicentre Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2020-10-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Sweden, Denmark and the Netherlands). In total, 50 adult patients with a hearing loss that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study.

The purpose of the study is to investigate the rate of successful BAHS use after implantation of the Ponto implant system using a minimally invasive surgical technique.

Detailed description: This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Sweden, Denmark and the Netherlands). In total, 50 adult patients with a hearing loss that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study.

The purpose of the study is to investigate the rate of successful BAHS use after implantation of the Ponto implant system using a minimally invasive surgical technique. 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 three 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
* Signed informed consent
* Adequate bone quality to allow for a Ponto implant insertion, as judged by the investigator, and an expected bone thickness above 5 mm, where no complications during surgery are expected
* Skin thickness of 12 mm or less at the implant site

Exclusion Criteria:

* Patient undergoing re-implantation
* Patient who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales
* Known condition or previous treatment that could jeopardize skin condition and wound healing over time as judged by the investigator (e.g. uncontrolled diabetes, previous radiotherapy in the area of interest)
* Known medical condition that contraindicate surgery as judged by the investigator
* Known and/or planned pregnancy at time of surgery
* Any other known condition that the investigator determines could interfere with compliance or investigation assessments
* Simultaneous participation in another clinical investigation with pharmaceutical and/or medical device which might cause interference with investigation participation

Primary outcomes:
measure: Implant/abutment complex capability to provide a reliable anchorage for a sound processor
timeFrame: 3 months after implant surgery
Secondary outcomes:
measure: Implant/abutment complex capability to provide reliable anchorage for sound processor
timeFrame: 12 months after implant surgery
measure: Implant survival
timeFrame: 12 months after implant surgery
measure: Implant stability
timeFrame: 12 months after implant surgery
measure: Holgers score distribution
timeFrame: 12 months after implant surgery
measure: Max Holgers score
timeFrame: 12 months after implant surgery
measure: Mild/Adverse skin reaction
timeFrame: 12 months after implant surgery
measure: IPS (Inflammation, Pain, Skin height) scores
timeFrame: 12 months after implant surgery
measure: Wound healing
timeFrame: 12 months after implant surgery
measure: Skin dehiscence
timeFrame: 12 months after implant surgery
measure: Skin overgrowth
timeFrame: 12 months after implant surgery
measure: Post-operative events around abutment
timeFrame: 12 months after implant surgery
measure: Patient-perceived presence of pain around abutment
timeFrame: 12 months after implant surgery
measure: Patient-perceived magnitude of pain around abutment
timeFrame: 12 months after implant surgery
measure: Patient-perceived presence of numbness around abutment
timeFrame: 12 months after implant surgery
measure: Patient-perceived magnitude of numbness around abutment
timeFrame: 12 months after implant surgery
measure: Duration of surgery
timeFrame: 3 months after implant surgery
measure: Sound processor usage
timeFrame: 12 months after implant surgery
measure: Subjective benefit after surgery
timeFrame: 3 months after surgery
Other outcomes:
measure: Safety outcome - Adverse events
timeFrame: 12 months after surgery
measure: Safety outcome - Device deficiences
timeFrame: 12 months after surgery
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Groningen
country: Netherlands
facility: Univerisity Medical Center Groningen
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Harry Powell, MD
role: PRINCIPAL_INVESTIGATOR
References: