Trial Outcomes & Findings for Long Term Stability, Survival and Tolerability of a (Novel) Baha® Implant System (NCT NCT02092610)

NCT ID: NCT02092610

Last Updated: 2016-02-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

77 participants

Primary outcome timeframe

At the single 60 months visit

Results posted on

2016-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Implant BI300 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	Novel Implant BI300 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 Study STARTED	25	52
Overall Study COMPLETED	17	40
Overall Study NOT COMPLETED	8	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Implant BI300 n=17 Participants 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	Novel Implant BI300 n=40 Participants 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 n=57 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	21 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	19 Participants n=7 Participants	30 Participants n=5 Participants
Age, Continuous	64.2 years STANDARD_DEVIATION 9.4 • n=5 Participants	55.4 years STANDARD_DEVIATION 12.8 • n=7 Participants	63.2 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	21 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	19 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment Sweden	2 participants n=5 Participants	7 participants n=7 Participants	9 participants n=5 Participants
Region of Enrollment Netherlands	11 participants n=5 Participants	26 participants n=7 Participants	37 participants n=5 Participants
Region of Enrollment United Kingdom	4 participants n=5 Participants	7 participants n=7 Participants	11 participants n=5 Participants
Implant stability measured by resonance frequence analysis	65.4 ISQ scores STANDARD_DEVIATION 3.2 • n=5 Participants	70.1 ISQ scores STANDARD_DEVIATION 2.4 • n=7 Participants	68.5 ISQ scores STANDARD_DEVIATION 3.4 • n=5 Participants

PRIMARY outcome

Timeframe: At the single 60 months visit

Population: 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.

Outcome measures

Outcome measures
Measure	Standard Implant BI300 n=17 Participants 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	Novel Implant BI300 n=40 Participants 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.
Implant Stability AUC ISQ baseline to 5 years	66.7 ISQ scores Standard Deviation 3.4	71.6 ISQ scores Standard Deviation 2.0
Implant Stability ISQ, 5 years	67.4 ISQ scores Standard Deviation 4.0	72.1 ISQ scores Standard Deviation 2.2

SECONDARY outcome

Timeframe: At the single 60 months visit

Population: Survival population, all patients in the ITT population in the original study CAG5173 (all randomized patients who get surgery).

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.

Outcome measures

Outcome measures
Measure	Standard Implant BI300 n=25 Participants 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	Novel Implant BI300 n=52 Participants 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.
Longterm Survival of Implant Survival rate including explants	90.0 % survival rate of implants	93.92 % survival rate of implants
Longterm Survival of Implant Survival rate excluding explants	95.0 % survival rate of implants	95.8 % survival rate of implants

SECONDARY outcome

Timeframe: At the single 60 months visit

Population: Five year follow up population

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

Outcome measures

Outcome measures
Measure	Standard Implant BI300 n=17 Participants 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	Novel Implant BI300 n=40 Participants 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.
Soft Tissue Status No irritation	52.9 % of participants	90.0 % of participants
Soft Tissue Status Removal of abutment is necessary due to infection	0 % of participants	0 % of participants
Soft Tissue Status Slight redness	23.5 % of participants	7.5 % of participants
Soft Tissue Status Red and slightly moist tissue	23.5 % of participants	2.5 % of participants
Soft Tissue Status Reddish and moist	0 % of participants	0 % of participants

SECONDARY outcome

Timeframe: 60 months

Population: These data are already presented in the "Longterm Survival of Implant" section.

Outcome measures

Outcome data not reported

Adverse Events

Standard Implant BI300

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Novel Implant BI300

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Myrthe Hol

Radboud University Hospital Nijmegen Medical Centre

Phone: (024) 36 14934

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60