Overview

This trial is active, not recruiting.

Conditions deafness, hearing loss, hearing loss, conductive, hearing loss, mixed conductive-sensorineural
Treatments minimally invasive surgery and ba400, traditional surgery and ba300
Sponsor Cochlear Bone Anchored Solutions
Start date February 2013
End date June 2015
Trial size 106 participants
Trial identifier NCT01796236, CBAS5439

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
This arm involves no softtissue reduction around the BA400 implant.
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)
This arm involves traditional soft tissue reduction around the BA300 implant
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).

Primary Outcomes

Measure
Number of participants with local Adverse Events as a measure of safety and tolerability
time frame: Day 10
Number of participants with local Adverse Events as a measure of safety and tolerability
time frame: Week 3
Number of participants with local Adverse Events as a measure of safety and tolerability
time frame: Week 6
Number of participants with local Adverse Events as a measure of safety and tolerability
time frame: Week 12
Number of participants with local Adverse Events as a measure of safety and tolerability
time frame: Week 24
Number of participants with local Adverse Events as a measure of safety and tolerability
time frame: Month 12
Number of participants with local Adverse Events as a measure of safety and tolerability
time frame: Month 24
Number of participants with local Adverse Events as a measure of safety and tolerability
time frame: Month 36

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Robert Stokroos, Professor
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Cochlear Bone Anchored Solutions.