Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation

Conductive Hearing Loss Clinical Trial

Official title:

Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064478
• Other study ID #: C47
• Status: Completed
• Phase: N/A
• First received: February 14, 2014
• Last updated: February 20, 2018
• Start date: February 2014
• Est. completion date: September 2017

Study information

• Verified date: February 2018
• Source: Oticon Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A bone anchored hearing system is used to improve hearing for patients with e.g. conductive/mixed hearing loss or single sided deafness.

With this type of system, a titanium implant is installed in the temporal bone, where it osseointegrates, i.e. integrates with the bone. An abutment (also in titanium) is attached to the implants and penetrates the skin. The sound processor (hearing aid) is then connected to the abutment, and can be attached and removed by the patient via a snap-coupling. This type of system has been successfully implanted in more than 100.000 patients. Recently, a simplified surgical procedure, where no skin thinning around the abutment is made, was approved. The results after using this installation technique, here called soft tissue preservation, are the focus of this study.

The objective of the study is to compare the outcomes after a surgical procedure with soft tissue preservation (test) and a surgery with soft tissue reduction (control) for placing Oticon Medical Ponto implants and abutments. The main hypothesis is that patient numbness around the implant is less in the test group compared to the control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2017
• Est. primary completion date: April 2015
• 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

• Bone thickness at the implant site of at least 4 mm

Exclusion Criteria:

• 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 >10 mm

Related Conditions & MeSH terms

• Conductive Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Hearing Loss, Mixed Conductive-Sensorineural
• Mixed Hearing Loss
• Single Sided Deafness

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Centre	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Oticon Medical	Statistiska konsultgruppen

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

den Besten CA, Bosman AJ, Nelissen RC, Mylanus EA, Hol MK. Controlled Clinical Trial on Bone-anchored Hearing Implants and a Surgical Technique With Soft-tissue Preservation. Otol Neurotol. 2016 Jun;37(5):504-12. doi: 10.1097/MAO.0000000000000994. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Skin height around abutment (in mm)		At surgery
Other	Skin height around abutment (in mm)		7 days post surgery
Other	Skin height around abutment (in mm)		21 days post surgery
Other	Skin height around abutment (in mm)		12 weeks post surgery
Other	Skin height around abutment (in mm)		6 months post surgery
Other	Skin height around abutment (in mm)		12 months post surgery
Other	Skin height around abutment (in mm)		36 months post surgery
Primary	Numbness around implant, specifically mean Total sensibility		36 months after surgery
Secondary	Length of surgery		At surgery
Secondary	Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient		0-6 months
Secondary	Mild/Adverse skin reaction	Adverse skin reaction is defined as a Holgers score = 2 at least one follow-up visit, including unplanned visits, during the analysis period Holgers score is a standardized score of skin reactions around a bone anchored hearing implant.	0-6 months
Secondary	Skin condition according to Holgers	Holgers score is a standardized score of skin reactions around a bone anchored hearing implant.	7 days after surgery
Secondary	Postoperative complications	Including; Bleeding or hematoma; Flap necrosis; Wound dehiscence; Other (description)	7 days to 6 months
Secondary	Proportion of patients with complete wound healing at first surgical visit		7 days
Secondary	Glasgow Benefit Inventory (GBI) scores		3 months
Secondary	Glasgow Health Status Inventory (GHSI) scores		Baseline (before surgery)
Secondary	Abbreviated profile of hearing aid benefit (APHAB) scores		Baseline (before surgery)
Secondary	Mean hours of use of the sound processor		0-6 months
Secondary	Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient		0-12 months
Secondary	Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient		0-36 months
Secondary	Bone conduction (BC) in-situ audiometric thresholds		6 months
Secondary	Bone conduction (BC) audiometric threshold	Measured with B-71	6 months
Secondary	Mean total sensibility around implant		Baseline (before surgery)
Secondary	Implant stability quotient (ISQ)		At surgery
Secondary	Time to implant loss		0-36 months
Secondary	Patient and Observer scar assessment score		21 days post surgery
Secondary	Mild/Adverse skin reaction	Adverse skin reaction is defined as a Holgers score = 2 at least one follow-up visit, including unplanned visits, during the analysis period	0-12 months
Secondary	Mild/Adverse skin reaction	Adverse skin reaction is defined as a Holgers score = 2 at least one follow-up visit, including unplanned visits, during the analysis period	0-36 months
Secondary	Skin condition according to Holgers		21 days
Secondary	Skin condition according to Holgers		12 weeks
Secondary	Skin condition according to Holgers		6 months
Secondary	Skin condition according to Holgers		1 year
Secondary	Skin condition according to Holgers		2 years
Secondary	Skin condition according to Holgers		3 years after surgery
Secondary	Postoperative complications	Including; Bleeding or hematoma; Flap necrosis; Wound dehiscence; Other (description)	7 days to 12 months
Secondary	Postoperative complications	Including; Bleeding or hematoma; Flap necrosis; Wound dehiscence; Other (description)	7 days to 36 months
Secondary	Glasgow Benefit Inventory (GBI) scores		12 months
Secondary	Glasgow Health Status Inventory (GHSI) scores		6 months
Secondary	Glasgow Health Status Inventory (GHSI) scores		36 months
Secondary	Abbreviated profile of hearing aid benefit (APHAB) scores		6 months
Secondary	Abbreviated profile of hearing aid benefit (APHAB) scores		36 months
Secondary	Mean hours of use of the sound processor		0-36 months
Secondary	Mean total sensibility around implant		21 days
Secondary	Mean total sensibility around implant		6 months
Secondary	Mean total sensibility around implant		12 months
Secondary	Mean total sensibility around implant		36 months
Secondary	Implant stability quotient (ISQ)		7 days post surgery
Secondary	Implant stability quotient (ISQ)		21 days post surgery
Secondary	Implant stability quotient (ISQ)		12 weeks post surgery
Secondary	Implant stability quotient (ISQ)		6 months post surgery
Secondary	Implant stability quotient (ISQ)		12 months post surgery
Secondary	Implant stability quotient (ISQ)		24 months post surgery
Secondary	Implant stability quotient (ISQ)		36 months post surgery
Secondary	Patient and Observer scar assessment score		6 months
Secondary	Patient and Observer scar assessment score		12 months
Secondary	Patient and Observer scar assessment score		36 months