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

NCT01796236 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2019-02-26

Study results available
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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

Interventions

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).

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).

Sponsors & Collaborators

  • Cochlear Bone Anchored Solutions

    lead INDUSTRY

Principal Investigators

  • Robert Stokroos, Professor · NT department, Oxford Building , Peter Debyelaan 25, 6202 AZ Maastricht, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-06-30
Completion
2017-11-30

Countries

  • France
  • Netherlands
  • Spain
  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01796236 on ClinicalTrials.gov