NCT02096809

Brief Summary

Objectives

  • To evaluate the safety of processor loading of the Cochlear BI300/BA400 implant system 1 week after implantation
  • To evaluate the short term soft tissue healing and the long term skin reaction, with the new Cochlear BI300/BA400 implant system using the linear incision without subcutaneous tissue reduction.
  • To produce reference data regarding the stability of the BI300/BA400 implant system. Study design: Prospective cohort study. Patients: 24 adults with anticipated normal skin and bone quality eligible for bone anchored implant surgery. Intervention: Loading of the sound processor one week after surgery Main outcome measures: Implant stability, soft tissue reaction, skin overgrowth, pain and numbness will be assessed. It is hypothesized that implant loading can be performed one week after surgery without any changes in implant stability, soft tissue reaction, skin overgrowth, pain or numbness around implant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

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

March 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 8, 2015

Status Verified

December 1, 2015

Enrollment Period

5 months

First QC Date

March 23, 2014

Last Update Submit

December 6, 2015

Conditions

Hearing Loss - Conductive

Keywords

Bone ConductionHearing loss - conductiveOsseointegrationProstheses and Implants

Outcome Measures

Primary Outcomes (7)

  • Implant stability

    Implant stability quotient measured at day of surgery. Implant stability is assessed using resonance frequency analysis. The measurement renders Implant Stability Quotient (ISQ) values from 1 to 100. Two perpendicular measurements are performed at each implant. The highest and lowest ISQ value out of three measurements obtained at each time point will be recorded. Measurements will be performed at the abutment level, and the Osstell ISQ instrument and SmartPeg Type 55 (Osstell, Gothenburg, Sweden) will be used.

    Day of surgery

  • Implant stability

    See description for Implant stability, day of surgery Implant stability is assessed using resonance frequency analysis.

    One week

  • Implant stability

    See description for Implant stability, day of surgery Implant stability is assessed using resonance frequency analysis.

    Two weeks

  • Implant stability

    See description for Implant stability, day of surgery Implant stability is assessed using resonance frequency analysis.

    One month

  • Implant stability

    See description for Implant stability, day of surgery Implant stability is assessed using resonance frequency analysis.

    3 months

  • Implant stability

    See description for Implant stability, day of surgery Implant stability is assessed using resonance frequency analysis.

    6 months

  • Implant stability

    See description for Implant stability, day of surgery Implant stability is assessed using resonance frequency analysis.

    12 months

Secondary Outcomes (24)

  • Soft tissue status

    One week

  • Soft tissue status

    Two weeks

  • Soft tissue status

    One month

  • Soft tissue status

    3 months

  • Soft tissue status

    6 months

  • +19 more secondary outcomes

Other Outcomes (1)

  • Implant loss

    Up to one year

Study Arms (1)

One week loading of Bone Anchored Hearing Aid (BAHA)

EXPERIMENTAL

Bone Anchored Hearing Aid (BAHA) loading after one week

Procedure: One week loading of Bone Anchored Hearing Aid (BAHA)Device: Cochlear Baha BI300/BA400 Implant System

Interventions

One week loading of Bone Anchored Hearing Aid (BAHA)PROCEDURE

Patients in this arm will be fitted with the BAHA one week after surgery.

One week loading of Bone Anchored Hearing Aid (BAHA)
Cochlear Baha BI300/BA400 Implant SystemDEVICE
One week loading of Bone Anchored Hearing Aid (BAHA)

Eligibility Criteria

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

You may qualify if:

  • Patients ≥ 18 years of age, with normal intelligence.
  • Absence of previous radiotherapy to the implant area.
  • Absence of active skin disease in the implant area.
  • Absence of diabetes.
  • Absence of osteoporosis
  • Absence of any relevant medical history or current disease/treatment/medication that may affect bone or skin quality in the implant area.

You may not qualify if:

  • No further

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, ENT-department

Aarhus, 8000, Denmark

Location

Related Publications (6)

  • 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

  • Larsson A, Wigren S, Andersson M, Ekeroth G, Flynn M, Nannmark U. Histologic evaluation of soft tissue integration of experimental abutments for bone anchored hearing implants using surgery without soft tissue reduction. Otol Neurotol. 2012 Oct;33(8):1445-51. doi: 10.1097/MAO.0b013e318268d4e0.

    PMID: 22918110BACKGROUND

  • Faber HT, Dun CA, Nelissen RC, Mylanus EA, Cremers CW, Hol MK. Bone-anchored hearing implant loading at 3 weeks: stability and tolerability after 6 months. Otol Neurotol. 2013 Jan;34(1):104-10. doi: 10.1097/MAO.0b013e318277a282.

    PMID: 23202148BACKGROUND

  • 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

  • Wazen JJ, Young DL, Farrugia MC, Chandrasekhar SS, Ghossaini SN, Borik J, Soneru C, Spitzer JB. Successes and complications of the Baha system. Otol Neurotol. 2008 Dec;29(8):1115-9. doi: 10.1097/MAO.0b013e318187e186.

    PMID: 18833013BACKGROUND

  • McLarnon CM, Johnson I, Davison T, Hill J, Henderson B, Leese D, Marley S. Evidence for early loading of osseointegrated implants for bone conduction at 4 weeks. Otol Neurotol. 2012 Dec;33(9):1578-82. doi: 10.1097/MAO.0b013e31826dba5f.

    PMID: 23069746BACKGROUND

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 V Johansen, D.MSc.

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

March 23, 2014

First Posted

March 26, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2014

Study Completion

September 1, 2015

Last Updated

December 8, 2015

Record last verified: 2015-12

Locations

DK(1)