ClinicalTrials.gov
ClinicalTrials.gov Menu

Long Term Stability, Survival and Tolerability of a (Novel) Baha® Implant System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02092610
Recruitment Status : Completed
First Posted : March 20, 2014
Results First Posted : January 11, 2016
Last Update Posted : February 15, 2016
Sponsor:
Information provided by (Responsible Party):
Cochlear Bone Anchored Solutions

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Conductive Hearing Loss
Interventions Device: Novel Implant BI300
Device: Standard Implant BI300
Enrollment 77
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Implant BI300 Novel Implant BI300
Hide Arm/Group Description

The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long

Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long

The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.

Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.

Period Title: Overall Study
Started 25 52
Completed 17 40
Not Completed 8 12
Arm/Group Title Standard Implant BI300 Novel Implant BI300 Total
Hide Arm/Group Description

The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long

Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long

The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.

Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.

Total of all reporting groups
Overall Number of Baseline Participants 17 40 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 40 participants 57 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  35.3%
21
  52.5%
27
  47.4%
>=65 years
11
  64.7%
19
  47.5%
30
  52.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 40 participants 57 participants
64.2  (9.4) 55.4  (12.8) 63.2  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 40 participants 57 participants
Female
7
  41.2%
21
  52.5%
28
  49.1%
Male
10
  58.8%
19
  47.5%
29
  50.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 17 participants 40 participants 57 participants
Sweden 2 7 9
Netherlands 11 26 37
United Kingdom 4 7 11
Implant stability measured by resonance frequence analysis   [1] 
Mean (Standard Deviation)
Unit of measure:  ISQ scores
Number Analyzed 17 participants 40 participants 57 participants
65.4  (3.2) 70.1  (2.4) 68.5  (3.4)
[1]
Measure Description: The ISQ value ranges from 1 to 100, the higher value, the higher the implant stabilty.
1.Primary Outcome
Title Implant Stability
Hide Description To show superiority of the novel implant compared to standard implants regarding stability of the implants measured as ISQ values at the abutment level. The ISQ value ranges from 1 to 100, the higher ISQ value, the higher the implant stabilty. Mean AUC 0-60 months ISQ represents a weighted average of the implant stability during the 60 months from start of the CAG5173 study to the measurement in this study CBAS5562. The ISQ 5 years value represents the single ISQ measurment at 5 years.
Time Frame At the single 60 months visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 5 year follow up population consisted of the patients in the ITT population (all randomized subjects who received surgery) in the CAG5173 study who attended this study which was a 5-year follow up visit.
Arm/Group Title Standard Implant BI300 Novel Implant BI300
Hide Arm/Group Description:

The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long

Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long

The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.

Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.

Overall Number of Participants Analyzed 17 40
Mean (Standard Deviation)
Unit of Measure: ISQ scores
AUC ISQ baseline to 5 years 66.7  (3.4) 71.6  (2.0)
ISQ, 5 years 67.4  (4.0) 72.1  (2.2)
2.Secondary Outcome
Title Longterm Survival of Implant
Hide Description

To compare the long term survival of the novel implant and abutment and the standard implant and abutment in the Baha system.

All patients will be asked if they have experienced any implant osseointegration problems which would have made the implant to get loose. The time from implant implantation until implant loss or removal will be collected. In case of implant removal, reason for removal shall be recorded.

Time Frame At the single 60 months visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Survival population, all patients in the ITT population in the original study CAG5173 (all randomized patients who get surgery).
Arm/Group Title Standard Implant BI300 Novel Implant BI300
Hide Arm/Group Description:

The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long

Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long

The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.

Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.

Overall Number of Participants Analyzed 25 52
Measure Type: Number
Unit of Measure: % survival rate of implants
Survival rate including explants 90.0 93.92
Survival rate excluding explants 95.0 95.8
3.Secondary Outcome
Title Soft Tissue Status
Hide Description

To evaluate the status of the soft tissue at the implant site.

The scale Holgers Index 4 is designed to capture signs and symptoms of inflammation or infection at the site of implantation. The scale should be completed at the visit.

The scale consists of the following steps:

0. No irritation. Epidermal debris removed, if present

  1. Slight redness. Local temporary treatment, if needed
  2. Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated
  3. Reddish and moist; sometimes granulations tissue, revision surgery is indicated
  4. Removal of the abutment/implant necessary due to infection R. Removal of abutment/implant for reasons not related to skin problems
Time Frame At the single 60 months visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Five year follow up population
Arm/Group Title Standard Implant BI300 Novel Implant BI300
Hide Arm/Group Description:

The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long

Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long

The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.

Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.

Overall Number of Participants Analyzed 17 40
Measure Type: Number
Unit of Measure: % of participants
No irritation 52.9 90.0
Slight redness 23.5 7.5
Red and slightly moist tissue 23.5 2.5
Reddish and moist 0 0
Removal of abutment is necessary due to infection 0 0
4.Secondary Outcome
Title Implant Survival
Hide Description [Not Specified]
Time Frame 60 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
These data are already presented in the "Longterm Survival of Implant" section.
Arm/Group Title Standard Implant BI300 Novel Implant BI300
Hide Arm/Group Description:

The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long

Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long

The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.

Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Implant BI300 Novel Implant BI300
Hide Arm/Group Description

The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long

Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long

The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.

Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.

All-Cause Mortality
Standard Implant BI300 Novel Implant BI300
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Implant BI300 Novel Implant BI300
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Implant BI300 Novel Implant BI300
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/40 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Myrthe Hol
Organization: Radboud University Hospital Nijmegen Medical Centre
Phone: (024) 36 14934
Responsible Party: Cochlear Bone Anchored Solutions
ClinicalTrials.gov Identifier: NCT02092610     History of Changes
Other Study ID Numbers: CBAS5562
First Submitted: March 14, 2014
First Posted: March 20, 2014
Results First Submitted: October 26, 2015
Results First Posted: January 11, 2016
Last Update Posted: February 15, 2016