Clinical trial NCT04310202: Multi-Centre Study on the Performance of the Ponto BHX Implant System (in Adult Patients)
Official title: A Prospective Multi-Centre Study on the Performance of the Ponto BHX Implant System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2020-03-17
Enrollment: 50
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 multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). 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. A total of 50 patients will be included in the study.

The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Biohelix (BHX) Implant system.

Detailed description: This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). 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. A total of 50 patients will be included in the study.

The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto BHX Implant system. 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
* Patients indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines
* Adequate bone quality to allow for a Ponto BHX implant insertion, as judged by the investigator, and an expected bone thickness above 3 mm, where no complications during surgery are expected

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 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 ratings
timeFrame: 12 months after implant surgery
measure: IPS (Inflammation, Pain, Skin height) scores
timeFrame: 12 months after implant surgery
measure: Patient-perceived presence of pain around implant/abutment
timeFrame: 12 months after implant surgery
measure: Patient-perceived magnitude of pain around implant/abutment
timeFrame: 12 months after implant surgery
measure: Patient-perceived presence of numbness around implant/abutment
timeFrame: 12 months after implant surgery
measure: Patient-perceived magnitude of numbness around implant/abutment
timeFrame: 12 months after implant surgery
measure: Skin/soft tissue overgrowth
timeFrame: 12 months after implant surgery
measure: Duration of surgery
timeFrame: At implant surgery
measure: Wound dehiscence
timeFrame: 12 months after implant surgery
measure: Wound healing time
timeFrame: 12 months after implant surgery
measure: Implant/abutment usage
timeFrame: 12 months after implant surgery
measure: Subjective benefit after implant surgery
timeFrame: At screening visit (visit before surgery)
measure: Subjective benefit after implant surgery
timeFrame: 6 months after implant surgery
measure: Subjective benefit after implant surgery
timeFrame: 3 months after implant surgery
measure: Subjective benefit after implant surgery
timeFrame: 12 months after implant surgery
Other outcomes:
measure: Safety outcome
timeFrame: 12 months after surgery
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: San Sebastián
country: Spain
facility: Hospital Universitario de Donostia
state: Gipuzkoa
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: University Hospital Birmingham NHS Foundation Trust
name: Rupan Banga, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: