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

Purpose

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.

Condition	Intervention
Hearing Loss, Conductive	Procedure: BAHA implant insertion

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of Soft Tissue Healing and Implant Stability of Cochlear Baha BI300 Implants Loaded From 2 Weeks Post-surgery: a Comparison Between Two Surgical Techniques.

Resource links provided by NLM:

Genetics Home Reference related topics: nonsyndromic deafness Pendred syndrome

MedlinePlus related topics: Hearing Aids Hearing Disorders and Deafness

U.S. FDA Resources

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:

Implant stability, day of surgery [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
Implant stability shall be assessed using resonance frequency analysis. The measurement renders Implant Stability Quotient (ISQ) values from 1 to 100. Two perpendicular measurements shall be performed at each implant. The highest and lowest ISQ value out of three measurements obtained at each time point shall be recorded. Measurements shall be performed at the abutment level, and the Osstell ISQ instrument and SmartPeg Type 55 (Osstell, Gothenburg, Sweden) shall be used.

Note: If a patient requires a change of abutment height, ISQ values shall be recorded on both abutment heights at the time of abutment change, in order to obtain a reference value for subsequent RFA measurements.
Implant stability, early healing phase [ Time Frame: 3 days postoperatively ] [ Designated as safety issue: No ]
See description for "Implant stability, day of surgery".
Implant stability, early healing phase [ Time Frame: 7 days postoperatively ] [ Designated as safety issue: No ]
See description for "Implant stability, day of surgery".
Implant stability, early healing phase [ Time Frame: 10 days postoperatively ] [ Designated as safety issue: No ]
See description for "Implant stability, day of surgery".
Implant stability, loading of implant [ Time Frame: 14 days postoperatively ] [ Designated as safety issue: No ]
See description for "Implant stability, day of surgery".
Implant stability, middle healing phase [ Time Frame: 21 days postoperatively ] [ Designated as safety issue: No ]
See description for "Implant stability, day of surgery".
Implant stability, middle healing phase [ Time Frame: 30 days postoperatively ] [ Designated as safety issue: No ]
See description for "Implant stability, day of surgery".
Implant stability, late healing phase [ Time Frame: 60 days postoperatively ] [ Designated as safety issue: No ]
See description for "Implant stability, day of surgery".
Implant stability, late healing phase [ Time Frame: 180 days postoperatively ] [ Designated as safety issue: No ]
See description for "Implant stability, day of surgery".
Implant stability, late healing phase [ Time Frame: 1 year postoperatively ] [ Designated as safety issue: No ]
See description for "Implant stability, day of surgery".

Secondary Outcome Measures:

Soft tissue status [ Time Frame: 3 days postoperatively ] [ Designated as safety issue: No ]
The status of the soft tissue around the abutment shall be assessed using the classification proposed by Holgers et al, referred to as Holgers Index. See scale below:

Grade 0 No irritation. Epidermal debris removed if present. Grade 1 Slight redness. Temporary local treatment. Grade 2 Red and slightly moist tissue. No granulation formation. Local treatment, extra controls.

Grade 3 Reddish and moist. Sometimes granulation tissue. Revision surgery is indicated.

Grade 4 Removal of skin-penetrating implant or abutment necessary due to infection.

Grade R Removal of implant for reasons not related to skin problems.
Soft tissue status [ Time Frame: 7 days postoperatively ] [ Designated as safety issue: No ]
See "Soft tissue status" - 3 days postoperatively
Soft tissue status [ Time Frame: 10 days postoperatively ] [ Designated as safety issue: No ]
See "Soft tissue status" - 3 days postoperatively.
Soft tissue status [ Time Frame: 14 days postoperatively ] [ Designated as safety issue: No ]
See "Soft tissue status" - 3 days postoperatively.
Soft tissue status [ Time Frame: 21 days postoperatively ] [ Designated as safety issue: No ]
See "Soft tissue status" - 3 days postoperatively.
Soft tissue status [ Time Frame: 30 days postoperatively ] [ Designated as safety issue: No ]
See "Soft tissue status" - 3 days postoperatively.
Soft tissue status [ Time Frame: 60 days postoperatively ] [ Designated as safety issue: No ]
See "Soft tissue status" - 3 days postoperatively.
Soft tissue status [ Time Frame: 180 days postoperatively ] [ Designated as safety issue: No ]
See "Soft tissue status" - 3 days postoperatively.
Soft tissue status [ Time Frame: 1 year postoperatively ] [ Designated as safety issue: No ]
See "Soft tissue status" - 3 days postoperatively.

Other Outcome Measures:

Loss of implant [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Every loss of implant will be recorded and reported to the manufacturer.
Change in health status [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The change in health status produced by the surgical intervention is evaluated with the Glasgow Benefit Inventory.

Estimated Enrollment:	42
Study Start Date:	August 2012
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dermatome BAHA implant insertion with Dermatome technique	Procedure: BAHA implant insertion The intervention is insertion of the Cochlear Bi300 to be used for bone anchored hearing aid. Other Name: Cochlear Bi300
Experimental: Linear incision BAHA implant insertion with linear incision	Procedure: BAHA implant insertion The intervention is insertion of the Cochlear Bi300 to be used for bone anchored hearing aid. Other Name: Cochlear Bi300

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Eligibility

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

Criteria

Inclusion Criteria:

Hearing loss suitable for bone anchored hearing aid
Capable of maintaining sufficient hygiene around the implant.

Exclusion Criteria:

Previous radiotherapy to the operation area
Diabetes
Skin disease in the operation area
Any relevant medical history or current disease/treatment/medication that may affect bone or skin quality in the implant area.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699620

Contacts

Contact: Lars Vendelbo Johansen, MD, DMSc	+45 78463172	larjoh@rm.dk
Contact: Morten Høgsbro, MD.	+45 78464886	mortls@rm.dk

Locations

Denmark
Aarhus University Hospital, ENT-department	Recruiting
Aarhus, Denmark, 8000
Principal Investigator: Lars Vendelbo Johansen, MD, DMSc
Sub-Investigator: Andreas Agger, MD
Sub-Investigator: Morten Høgsbro, MD

Sponsors and Collaborators

Aarhus University Hospital

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

Investigators

Principal Investigator:

Lars Vendelbo Johansen, MD, DMSc

Aarhus University Hospital

More Information

Publications:

Dun CA, de Wolf MJ, Hol MK, Wigren S, Eeg-Olofsson M, Green K, Karlsmo A, Flynn MC, Stalfors J, Rothera M, Mylanus EA, Cremers CW. Stability, survival, and tolerability of a novel baha implant system: six-month data from a multicenter clinical investigation. Otol Neurotol. 2011 Aug;32(6):1001-7.

Hultcrantz M. Outcome of the bone-anchored hearing aid procedure without skin thinning: a prospective clinical trial. Otol Neurotol. 2011 Sep;32(7):1134-9.

Holgers KM, Tjellström A, Bjursten LM, Erlandsson BE. Soft tissue reactions around percutaneous implants: a clinical study of soft tissue conditions around skin-penetrating titanium implants for bone-anchored hearing aids. Am J Otol. 1988 Jan;9(1):56-9.

Robinson K, Gatehouse S, Browning GG. Measuring patient benefit from otorhinolaryngological surgery and therapy. Ann Otol Rhinol Laryngol. 1996 Jun;105(6):415-22.

Responsible Party:	Dr. Lars Vendelbo Johansen, MD, DMSc, Aarhus University Hospital
ClinicalTrials.gov Identifier:	NCT01699620 History of Changes
Other Study ID Numbers:	66.20.19.1.LV
Study First Received:	September 25, 2012
Last Updated:	February 22, 2013
Health Authority:	Denmark: Danish Health and Medicines Authority

Keywords provided by Aarhus University Hospital:

Bone anchored hearing aid
Soft tissue healing
Implant stability
Linear incision

Dermatome technique
Hearing Aids
Implants, Artificial
Surgical Procedures, Operative

Additional relevant MeSH terms:

Hearing Loss
Deafness
Hearing Loss, Conductive
Hearing Disorders
Ear Diseases

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

ClinicalTrials.gov processed this record on May 19, 2013