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Clinical and Health Economic Evaluation With a New Baha® Abutment Combined With a Minimally Invasive Surgical Technique

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ClinicalTrials.gov Identifier: NCT01796236
Recruitment Status : Active, not recruiting
First Posted : February 21, 2013
Results First Posted : December 22, 2015
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Cochlear Bone Anchored Solutions

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Deafness
Hearing Loss
Hearing Loss, Conductive
Hearing Loss, Mixed Conductive-Sensorineural
Interventions Device: Minimally invasive surgery and BA400
Device: Traditional surgery and BA300
Enrollment 106
Recruitment Details  
Pre-assignment Details 106 subjects signed informed consent. Before surgery one subject cancelled surgery, one subject withdraw consent and one subject got the wrong allocation due to logistic problems. This resulted in that 103 subjects received the allocated intervention (51 test and 52 control).
Arm/Group Title Minimally Invasive Surgery and BA400 Traditional Surgery and BA300
Hide Arm/Group Description

This arm involves no soft tissue reduction around the BA400 implant.

Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)

This arm involves traditional soft tissue reduction around the BA300 implant

Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).

Period Title: Overall Study
Started 51 52
Completed 49 50
Not Completed 2 2
Arm/Group Title Minimally Invasive Surgery and BA400 Traditional Surgery and BA300 Total
Hide Arm/Group Description

This arm involves no soft tissue reduction around the BA400 implant.

Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)

This arm involves traditional soft tissue reduction around the BA300 implant

Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).

Total of all reporting groups
Overall Number of Baseline Participants 51 52 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 52 participants 103 participants
54.2  (10.9) 51.5  (16.6) 52.4  (14.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 103 participants
Female
25
  49.0%
27
  51.9%
52
  50.5%
Male
26
  51.0%
25
  48.1%
51
  49.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 103 participants
Netherlands 26 29 55
Sweden 5 4 9
France 5 5 10
Spain 15 14 29
Use of nicotine  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 103 participants
No 37 38 75
Yes 14 13 27
Unknown 0 1 1
Type of hearing loss  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 103 participants
Conductive 5 10 15
Mixed 31 35 66
Single-Sided Sensorineural 15 7 22
1.Primary Outcome
Title Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability
Hide Description

Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events:

  1. Holgers Index >=2 any time between 3 weeks to 1 year
  2. Any overgrowth any time between 3 weeks to 1 year
  3. Pain (scar/neuropathic) according to POSAS >=3 any time between 3 weeks to 1 year
  4. Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.
Arm/Group Title Minimally Invasive Surgery and BA400 Traditional Surgery and BA300
Hide Arm/Group Description:

This arm involves no softtissue reduction around the BA400 implant.

Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).

This arm involves traditional soft tissue reduction around the BA300 implant

Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).

Overall Number of Participants Analyzed 51 52
Measure Type: Number
Unit of Measure: participants
Combined endpoint score = 0 15 7
Combined endpoint score = 1 14 13
Combined endpoint score = 2 14 24
Combined endpoint score = 3 7 8
Combined endpoint score = 4 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Minimally Invasive Surgery and BA400, Traditional Surgery and BA300
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Numbness
Hide Description Numbness summary analysis.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.
Arm/Group Title Minimally Invasive Surgery and BA400 Traditional Surgery and BA300
Hide Arm/Group Description:

This arm involves no soft tissue reduction around the BA400 implant.

Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)

This arm involves traditional soft tissue reduction around the BA300 implant

Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).

Overall Number of Participants Analyzed 51 52
Measure Type: Number
Unit of Measure: participants
No numbness 27 9
Numbness within 2 cm from the abutment 17 12
Numbness within and beyond 2 cm from the abutment 7 31
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Minimally Invasive Surgery and BA400, Traditional Surgery and BA300
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Pain in the Scar and Neuropathic Pain
Hide Description The subject rated the following questions ‘has the scar been painful the past few weeks’ and ‘have you had any neuropathic pain during the past weeks’ on the 1-10 scale were 1 = no, not at all and 10 = yes, very much.
Time Frame Day 10, Weeks 3, 6, 12, 24 and Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward. There were only statistically significant differences between the two groups in this population at 3 and 12 weeks and only regarding neuropathic pain.
Arm/Group Title Minimally Invasive Surgery and BA400 Traditional Surgery and BA300
Hide Arm/Group Description:

This arm involves no soft tissue reduction around the BA400 implant.

Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)

This arm involves traditional soft tissue reduction around the BA300 implant

Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).

Overall Number of Participants Analyzed 51 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 10, Neuropathic pain 1.45  (1.47) 1.65  (1.75)
Day 10, Scar pain 1.90  (1.94) 2.08  (1.64)
Week 3, Neuropathic pain 1.38  (1.26) 1.75  (1.43)
Week 3, Scar pain 1.78  (1.52) 1.71  (1.24)
Week 6, Neuropathic pain 1.18  (0.72) 1.45  (1.19)
Week 6, Scar pain 1.58  (1.14) 1.80  (1.34)
Week 12, Neuropathic pain 1.06  (0.25) 1.70  (1.53)
Week 12, Scar pain 2.00  (1.41) 2.06  (1.63)
Week 24, Neuropathic pain 1.19  (0.82) 1.41  (1.48)
Week 24, Scar pain 1.70  (1.25) 2.02  (1.72)
Month 12, Neuropathic pain 1.26  (1.05) 1.77  (1.97)
Month 12, Scar pain 2.04  (2.01) 2.02  (1.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Minimally Invasive Surgery and BA400, Traditional Surgery and BA300
Comments Week 3, Neuropathic pain
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Minimally Invasive Surgery and BA400, Traditional Surgery and BA300
Comments Week 12, Neuropathic pain
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Wound Healing
Hide Description A surgeon or a surgical nurse determined if the wound was healed or not healed.
Time Frame Day 10, Weeks 3, 6, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward. There was only a statistically significant difference between the two groups in this population at day 10.
Arm/Group Title Minimally Invasive Surgery and BA400 Traditional Surgery and BA300
Hide Arm/Group Description:

This arm involves no soft tissue reduction around the BA400 implant.

Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)

This arm involves traditional soft tissue reduction around the BA300 implant

Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).

Overall Number of Participants Analyzed 51 52
Measure Type: Number
Unit of Measure: participants
Day 10, Wound not healed 4 14
Day 10, Wound healed 47 38
Week 3, Wound not healed 4 8
Week 3, Wound healed 46 44
Week 6, Wound not healed 3 3
Week 6, Wound healed 47 48
Week 12, Wound not healed 1 0
Week 12, Wound healed 46 50
Week 24, Wound not healed 0 0
Week 24, Wound healed 47 46
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Minimally Invasive Surgery and BA400, Traditional Surgery and BA300
Comments Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Surgery Time
Hide Description Surgery time (minutes) was recorded
Time Frame Day 0
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.
Arm/Group Title Minimally Invasive Surgery and BA400 Traditional Surgery and BA300
Hide Arm/Group Description:

This arm involves no soft tissue reduction around the BA400 implant.

Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)

This arm involves traditional soft tissue reduction around the BA300 implant

Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).

Overall Number of Participants Analyzed 51 52
Mean (Standard Deviation)
Unit of Measure: minutes
15.3  (6.2) 24.7  (8.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Minimally Invasive Surgery and BA400, Traditional Surgery and BA300
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Inflammation
Hide Description Max of Holgers index from day 10 to month 12 was recorded, using the Holgers scale from 0 - 4, where 0 = no inflammation and 4 = removal of abutment/implant necessary due to infection.
Time Frame Day 10 to 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.
Arm/Group Title Minimally Invasive Surgery and BA400 Traditional Surgery and BA300
Hide Arm/Group Description:

This arm involves no soft tissue reduction around the BA400 implant.

Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)

This arm involves traditional soft tissue reduction around the BA300 implant

Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).

Overall Number of Participants Analyzed 51 52
Measure Type: Number
Unit of Measure: participants
Max of Holgers index = 0 10 8
Max of Holgers index = 1 28 32
Max of Holgers index = 2 7 10
Max of Holgers index = 3 7 2
Max of Holgers index = 4 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Minimally Invasive Surgery and BA400, Traditional Surgery and BA300
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Minimally Invasive Surgery and BA400 Traditional Surgery and BA300
Hide Arm/Group Description

This arm involves no soft tissue reduction around the BA400 implant.

Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)

This arm involves traditional soft tissue reduction around the BA300 implant

Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).

All-Cause Mortality
Minimally Invasive Surgery and BA400 Traditional Surgery and BA300
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Minimally Invasive Surgery and BA400 Traditional Surgery and BA300
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/51 (5.88%)      7/52 (13.46%)    
Cardiac disorders     
Arrythmia *  0/51 (0.00%)  0 1/52 (1.92%)  2
General disorders     
Accidental death *  1/51 (1.96%)  1 0/52 (0.00%)  0
Device expulsion *  0/51 (0.00%)  0 1/52 (1.92%)  1
Device failure *  1/51 (1.96%)  1 0/52 (0.00%)  0
Implant site pain *  0/51 (0.00%)  0 1/52 (1.92%)  1
Infections and infestations     
Infected skin ulcer *  0/51 (0.00%)  0 1/52 (1.92%)  1
Injury, poisoning and procedural complications     
Road traffic accident *  1/51 (1.96%)  1 0/52 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pancreatic carcinoma *  0/51 (0.00%)  0 1/52 (1.92%)  1
Pregnancy, puerperium and perinatal conditions     
Ectopic pregnancy *  0/51 (0.00%)  0 1/52 (1.92%)  1
Psychiatric disorders     
Depression *  0/51 (0.00%)  0 1/52 (1.92%)  1
Surgical and medical procedures     
Aortic valve replacement *  0/51 (0.00%)  0 1/52 (1.92%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Minimally Invasive Surgery and BA400 Traditional Surgery and BA300
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/51 (62.75%)      37/52 (71.15%)    
Ear and labyrinth disorders     
Tinnitus *  3/51 (5.88%)  3 0/52 (0.00%)  0
General disorders     
Implant site scar *  2/51 (3.92%)  2 3/52 (5.77%)  3
Instillation site erythema *  24/51 (47.06%)  40 17/52 (32.69%)  25
Infections and infestations     
Ear infection *  1/51 (1.96%)  1 4/52 (7.69%)  5
Nasopharyngitis *  4/51 (7.84%)  4 4/52 (7.69%)  4
Otitis media *  0/51 (0.00%)  0 3/52 (5.77%)  4
Injury, poisoning and procedural complications     
Wound dehiscence *  1/51 (1.96%)  1 6/52 (11.54%)  9
Wound secretion *  15/51 (29.41%)  21 12/52 (23.08%)  14
Nervous system disorders     
Dizziness postural *  0/51 (0.00%)  0 3/52 (5.77%)  3
Headache *  0/51 (0.00%)  0 3/52 (5.77%)  4
Skin and subcutaneous tissue disorders     
Excessive granulation tissue *  6/51 (11.76%)  8 2/52 (3.85%)  2
Excessive skin *  1/51 (1.96%)  1 3/52 (5.77%)  3
Skin swelling *  3/51 (5.88%)  4 1/52 (1.92%)  1
*
Indicates events were collected by non-systematic assessment
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: Professor Robert Stokroos
Organization: Head and Neck Surgery, Maastricht University Medical Center, Maastricht
Phone: 0031 - 43 387 54 00
Responsible Party: Cochlear Bone Anchored Solutions
ClinicalTrials.gov Identifier: NCT01796236     History of Changes
Other Study ID Numbers: CBAS5439
First Submitted: January 16, 2013
First Posted: February 21, 2013
Results First Submitted: November 18, 2015
Results First Posted: December 22, 2015
Last Update Posted: March 14, 2017