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Comparative Study of Two Surgical Techniques for Soft Tissue Healing and Implant Stability of Cochlear BI300 Implants.

NCT01699620 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2015-01-15

No results posted yet for this study

Summary

The study compares two different operative techniques for placement of the Cochlear Bi300 implant to be used for bone anchored hearing aid. The operative techniques to be compared are

* Dermatome technique with soft tissue reduction
* Linear incision with minimal or no soft tissue reduction

The hypothesis is that the operative techniques are comparable with regard to implant stability, soft tissue healing and loss of sensibility around the implant.

To evaluate the evolution of implant stability during the early healing period after implantation, which is the most critical period for osseointegrated implants, in particular when early loading protocols are used.

To compare soft tissue healing around Baha implants placed according to the recommended surgical technique with skin transplant and Baha implants without performing skin reduction.

To compare the loss of sensibility of the skin around the Baha implant (some loss of cutaneous sensibility nerves in the transplant procedure) between the two surgical procedures.

While the study focuses on the early healing period (3 months), long-term safety data will also be collected after 6 months and 1-year.

The study will also evaluate the change in health status produced by the surgical intervention.

Conditions

  • Hearing Loss, Conductive

Interventions

PROCEDURE

BAHA implant insertion

The intervention is insertion of the Cochlear Bi300 to be used for bone anchored hearing aid.

Sponsors & Collaborators

  • Denmark: Danaflex A/S, national distributor of Cochlear Ltd

    collaborator UNKNOWN

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Lars Vendelbo Johansen, MD, DMSc · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-05-31
Completion
2014-06-30

Countries

  • Denmark

Study Locations

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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 NCT01699620 on ClinicalTrials.gov