NCT01699620

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

January 15, 2015

Status Verified

January 1, 2015

Enrollment Period

9 months

First QC Date

September 25, 2012

Last Update Submit

January 13, 2015

Conditions

Hearing Loss, Conductive

Keywords

Bone anchored hearing aidSoft tissue healingImplant stabilityLinear incisionDermatome techniqueHearing AidsImplants, ArtificialSurgical Procedures, Operative

Outcome Measures

Primary Outcomes (10)

  • Implant stability, day of surgery

    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.

    Day of surgery

  • Implant stability, early healing phase

    See description for "Implant stability, day of surgery".

    3 days postoperatively

  • Implant stability, early healing phase

    See description for "Implant stability, day of surgery".

    7 days postoperatively

  • Implant stability, early healing phase

    See description for "Implant stability, day of surgery".

    10 days postoperatively

  • Implant stability, loading of implant

    See description for "Implant stability, day of surgery".

    14 days postoperatively

  • Implant stability, middle healing phase

    See description for "Implant stability, day of surgery".

    21 days postoperatively

  • Implant stability, middle healing phase

    See description for "Implant stability, day of surgery".

    30 days postoperatively

  • Implant stability, late healing phase

    See description for "Implant stability, day of surgery".

    60 days postoperatively

  • Implant stability, late healing phase

    See description for "Implant stability, day of surgery".

    180 days postoperatively

  • Implant stability, late healing phase

    See description for "Implant stability, day of surgery".

    1 year postoperatively

Secondary Outcomes (9)

  • Soft tissue status

    3 days postoperatively

  • Soft tissue status

    7 days postoperatively

  • Soft tissue status

    10 days postoperatively

  • Soft tissue status

    14 days postoperatively

  • Soft tissue status

    21 days postoperatively

  • +4 more secondary outcomes

Other Outcomes (2)

  • Loss of implant

    12 months

  • Change in health status

    3 months

Study Arms (2)

Dermatome

EXPERIMENTAL

BAHA implant insertion with Dermatome technique

Procedure: BAHA implant insertion

Linear incision

EXPERIMENTAL

BAHA implant insertion with linear incision

Procedure: BAHA implant insertion

Interventions

BAHA implant insertionPROCEDURE

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

Also known as: Cochlear Bi300
DermatomeLinear incision

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, ENT-department

Aarhus, 8000, Denmark

Location

Related Publications (7)

  • 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. doi: 10.1097/MAO.0b013e3182267e9c.

    PMID: 21725257BACKGROUND

  • Dun CAJ, Faber HT, Mylanus EA, Cremers CW, Hol MK. Implant stability after earlier loading of the Baha BI300 implant. Proceedings of the Third International Symposium for Bone Conduction Hearing - Craniofacial Osseointegration; 2011 Mar 23-26; Sarasota, USA.

    BACKGROUND

  • McLarnon C, Johnson I, Davison T, Hill J, Henderson B, Leese D, Morley D. Evidence for early loading of Baha BI300 system at four weeks. Proceedings of the Third International Symposium for Bone Conduction Hearing - Craniofacial Osseointegration; 2011 Mar 23-26; Sarasota, USA.

    BACKGROUND

  • Green KM, Exley RP, Bruce IA, Andrew R. First experiences of loading a Baha sound processor at 2 weeks following surgery. Presented at the Third International Symposium for Bone Conduction Hearing - Craniofacial Osseointegration in Sarasota, USA, 23-26 March 2011

    BACKGROUND

  • 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. doi: 10.1097/MAO.0b013e31822a1c47.

    PMID: 21817939BACKGROUND

  • Holgers KM, Tjellstrom 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.

    PMID: 3364537BACKGROUND

  • Robinson K, Gatehouse S, Browning GG. Measuring patient benefit from otorhinolaryngological surgery and therapy. Ann Otol Rhinol Laryngol. 1996 Jun;105(6):415-22. doi: 10.1177/000348949610500601.

    PMID: 8638891BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lars Vendelbo Johansen, MD, DMSc

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DMSc

Study Record Dates

First Submitted

September 25, 2012

First Posted

October 3, 2012

Study Start

August 1, 2012

Primary Completion

May 1, 2013

Study Completion

June 1, 2014

Last Updated

January 15, 2015

Record last verified: 2015-01

Locations

DK(1)