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

Purpose

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).

Condition	Intervention
Deafness Hearing Loss Hearing Loss, Conductive Hearing Loss, Mixed Conductive-Sensorineural	Device: Minimally invasive surgery and BA400 Device: Traditional surgery and BA300

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Clinical and Health Economic Evaluation of a New Baha® Abutment, With a Minimally Invasive Surgical Technique. An International Multicentre, Open, Randomised, Comparative, Parallel Group, Investigation. 1y Investigation, 2y Follow-up

Resource links provided by NLM:

Genetics Home Reference related topics: nonsyndromic deafness Pendred syndrome

MedlinePlus related topics: Hearing Disorders and Deafness

U.S. FDA Resources

Further study details as provided by Cochlear Bone Anchored Solutions:

Primary Outcome Measures:

Number of participants with local Adverse Events as a measure of safety and tolerability [ Time Frame: Day 10 ] [ Designated as safety issue: Yes ]
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
Number of participants with local Adverse Events as a measure of safety and tolerability [ Time Frame: Week 3 ] [ Designated as safety issue: Yes ]
Number of participants with local Adverse Events as a measure of safety and tolerability [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
Number of participants with local Adverse Events as a measure of safety and tolerability [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
Number of participants with local Adverse Events as a measure of safety and tolerability [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Number of participants with local Adverse Events as a measure of safety and tolerability [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
Number of participants with local Adverse Events as a measure of safety and tolerability [ Time Frame: Month 24 ] [ Designated as safety issue: Yes ]
Number of participants with local Adverse Events as a measure of safety and tolerability [ Time Frame: Month 36 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Total cost of the surgical procedure, complications and number of wound dressings sessions [ Time Frame: Day 10, Weeks 3, 6, 12, 24 and Months 12, 24, 36 ] [ Designated as safety issue: No ]
Direct medical cost associated with the surgery (time to perform surgery, number of wound dressings sessions and cost to treat complications) will be calculated for each subject using standard cost/unit in each participating country.

Other Outcome Measures:

Aesthetic outcome [ Time Frame: Months 6, 12 and 36 ] [ Designated as safety issue: No ]
Patient and Observer Scar Assessment Scale (POSAS) v 2.0
Quality of Life [ Time Frame: Baseline Months 6, 12 and 36 ] [ Designated as safety issue: No ]
Health Utility Index and Abbreviated Profile of Hearing Aid Benefit
Adverse Events [ Time Frame: Day 10, Weeks 3, 6, 12, 24 and Months 12, 24, 36 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	106
Study Start Date:	February 2013
Estimated Study Completion Date:	September 2016
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Minimally invasive surgery and BA400	Device: Minimally invasive surgery and BA400 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).
Active Comparator: Traditional surgery and BA300	Device: Traditional surgery and BA300 The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Eligible for the Baha system
Signed informed consent

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796236

Contacts

Contact: Johan I Blechert

+46 31 792 4632

jblechert@cochlear.com

Locations

France
Service ORL	Not yet recruiting
Toulouse, France, 31059
Contact: Olivier Deguine, Prof.
Principal Investigator: Olivier Deguine, Prof.
Netherlands
Dept. ENT/KNO	Recruiting
Eindhoven, Netherlands, 5623
Contact: Dionisius Mateijsen, Phd 0031 6 55706451 nies.mateijsen@catharinaziekenhuis.nl
Principal Investigator: Dionisius Mateijsen, Phd
NT department	Recruiting
Maastricht, Netherlands, 6202
Contact: Marc Van Hoof marc.hoofvan@mumc.nl
Principal Investigator: Robert Stokroos, Professor
Spain
Otorhinolaryngology, Hospital Clinico Universitario De Valencia	Recruiting
Valencia, Spain, ES-46010
Principal Investigator: Jamie Marco Algarra, Professor
Sweden
ENT Clinic	Recruiting
Gothenburg, Sweden, 411 35
Contact: Joacim Stalfors +46 (0)73 64 21 613 joacim@stalfors.se
Principal Investigator: Joacim Stalfors

Sponsors and Collaborators

Cochlear Bone Anchored Solutions

Investigators

Principal Investigator:

Robert Stokroos, Professor

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

More Information

No publications provided

Responsible Party:	Cochlear Bone Anchored Solutions
ClinicalTrials.gov Identifier:	NCT01796236 History of Changes
Other Study ID Numbers:	CBAS5439
Study First Received:	January 16, 2013
Last Updated:	April 29, 2013
Health Authority:	Netherlands: Medical Ethics Review Committee (METC) Sweden: Regional Ethical Review Board

Keywords provided by Cochlear Bone Anchored Solutions:

Bone anchored hearing aid
Bone anchored implant
Abbreviated Profile of Hearing Aid Benefit (APHAB)

Health Utility Index (HUI)
Holgers Index
Implant stability

Additional relevant MeSH terms:

Deafness
Hearing Loss
Hearing Loss, Conductive
Hearing Loss, Mixed Conductive-Sensorineural
Hearing Disorders
Ear Diseases

Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013