Clinical and Health Economic Evaluation With a New Baha® Abutment Combined With a Minimally Invasive Surgical Technique

NCT01796236 | Completed Results

• 1 other identifier: CBAS5439
• Study Type: interventional
• Target: 106
• Locations: 4 countries
• Sites: 7

Brief Summary

To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction of inflammation/infection, overgrowth, pain and numbness at the site of implantation compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment). To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction in direct medical costs, due to shorter surgical procedures, faster wound healing and less complications compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment).

Conditions

Deafness; Hearing Loss; Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural

Keywords

Bone anchored hearing aid; Bone anchored implant; Abbreviated Profile of Hearing Aid Benefit (APHAB); Health Utility Index (HUI); Holgers Index; Implant stability

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability

  Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events: 1. Holgers Index \>=2 any time between 3 weeks to 1 year 2. Any overgrowth any time between 3 weeks to 1 year 3. Pain (scar/neuropathic) according to POSAS \>=3 any time between 3 weeks to 1 year 4. Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject.

  12 months

• Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability

  Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events: 1. Holgers Index \>=2 any time between 3 weeks to 1 year 2. Any overgrowth any time between 3 weeks to 1 year 3. Pain (scar/neuropathic) according to POSAS \>=3 any time between 3 weeks to 1 year 4. Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject.

  36 months

Secondary Outcomes (12)

• Surgery Time

  Day 0

• Wound Healing

  Day 10, Weeks 3, 6, 12 and 24

• Inflammation - Max of Holgers Index

  From Day 10 to 12 Months, and to 36 Months

• Inflammation - Holgers Index by Visit

  Day 10, Weeks 3, 6, 12, 24, months 12, 24 and 36

• Max Numbness

  12 & 36 months

Other Outcomes (7)

• Health Utilies Index (HUI-III & HUI-II)

  baseline (pre-surgery), week 24, months 12 and 36

• Abbreviated Profile of Hearing Aid Benefit (APHAB)

  Pre-surgery (baseline) to 24 weeks, 12 and 36 months

• Use of Sound Processor

  Weeks 6, 12, 24, Months 12, 24, 36

Study Arms (2)

Minimally invasive surgery and BA400

ACTIVE COMPARATOR

This arm involves no soft tissue reduction around the BA400 implant.

Device: Minimally invasive surgery and BA400

Traditional surgery and BA300

ACTIVE COMPARATOR

This arm involves traditional soft tissue reduction around the BA300 implant

Device: Traditional surgery and BA300

Interventions

Minimally invasive surgery and BA400 DEVICE

The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).

Minimally invasive surgery and BA400

Traditional surgery and BA300 DEVICE

The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).

Traditional surgery and BA300

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible for the Baha system
• Signed informed consent

You may not qualify if:

• Patient scheduled for simultaneously bilateral implant surgery
• Uncontrolled diabetes as judged by the investigator
• Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids
• Unable to follow the cleaning instruction
• Unable to follow investigational procedures, e.g. to complete quality of life scales
• Participation in another investigation with pharmaceuticals and/or device
• Condition that may have an impact on the outcome of the investigation as judged by the investigator
• Suitable implant position for the 4 mm implant not found during surgery due to insufficient bone quality and/or bone thickness

Sponsors & Collaborators

• Cochlear Bone Anchored Solutions: lead

Study Sites (7)

Service ORL

Toulouse, 31059, France

Location

KNO arts, Amphia Ziekenhuis

Breda, Netherlands

Location

Deventer Ziekenhuis

Deventer, Netherlands

Location

Dept. ENT/KNO

Eindhoven, 5623, Netherlands

Location

NT department

Maastricht, 6202, Netherlands

Location

Otorhinolaryngology, Hospital Clinico Universitario De Valencia

Valencia, ES-46010, Spain

Location

ENT Clinic

Gothenburg, 411 35, Sweden

Location

Related Publications (1)

• van Hoof M, Wigren S, Ivarsson Blechert J, Molin M, Andersson H, Mateijsen DJM, Bom SJH, Calmels MN, van der Rijt AJM, Flynn MC, van Tongeren J, Hof JR, Brunings JW, Anteunis LJC, Marco Algarra J, Stokroos RJ, Joore MA. A Multinational Cost-Consequence Analysis of a Bone Conduction Hearing Implant System-A Randomized Trial of a Conventional vs. a Less Invasive Treatment With New Abutment Technology. Front Neurol. 2020 Mar 13;11:106. doi: 10.3389/fneur.2020.00106. eCollection 2020.

  PMID: 32231633 DERIVED

MeSH Terms

Conditions

Deafness; Hearing Loss; Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural

Interventions

Minimally Invasive Surgical Procedures

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Limitations and Caveats

The Holgers Index was developed to assess the soft tissue status in relation to soft tissue reduction surgery, not tissue preservation surgery. There is community discussion as to whether it is appropriate for preservation surgery analysis.

Results Point of Contact

• Title: Professor Robert Stokroos
• Organization: Ear Nose Throat, University Medical Center Utrecht, Utrecht

R.J.Stokroos@umcutrecht.nl

0031 8875 56644

Study Officials

• Robert Stokroos, Professor

  NT department, Oxford Building , Peter Debyelaan 25, 6202 AZ Maastricht, The Netherlands

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: February 21, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: November 1, 2017
• Last Updated: February 26, 2019
• Results First Posted: December 22, 2015

Record last verified: 2019-02

Locations

FR (1); NL (4); ES (1); SE (1)