Clinical Trial: Comparative Study of Two Surgical Techniques for Soft Tissue Healing and Implant Stability of Cochlear BI300 Implants.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Evaluation of Soft Tissue Healing and Implant Stability of Cochlear Baha BI300 Implants Loaded From 2 Weeks Post-surgery: a Comparison Between Two Surgical Techniques.
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.
Detailed Summary:
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BACKGROUND
Implant stability
Until recently, the implants used in Baha surgery have exclusively been standard Brånemark type of titanium implants with an as-machined surface finish. The recommended procedure for Baha implantation with the machined titanium implants uses a 12-week healing period before loading the implant with a sound processor, in order to allow sufficient time for the implant to become integrated in the bone. The new Cochlear Baha BI300 Series implant has been designed to improve implant stability at placement and over time, thus making it possible to reduce the time to sound processor fitting. The implant features a wider diameter compared to the previous generation Baha implant, small-sized threads at the cylindrical portion of the implant underneath the flange, and a roughened implant surface.
Six-month data from a multi-centre clinical investigation comparing the new implant with the previous generation Baha implant using a 6-week loading protocol, shows significantly higher Implant Stability Quotient (ISQ) values (measured by resonance frequency analysis) for the new implant at each time point, and no reduction in stability after loading.1 The data from the study suggest that the implant stability achieved 6 weeks after implantation is sufficient to support the sound processor. The data also suggest that a further reduction of the time to sound processor fitting may be possible, provided favourable bone conditions at the implant site and provided satisfactory soft tissue status at the time of loading. Hence, a clinical investigation with implant loading 21 days post-surgery was initiated by the team in Nijmegen, and 6-month data from the investigation confirm that it i
Sponsor: Aarhus University Hospital
Current Primary Outcome:
- Implant stability, day of surgery [ Time Frame: 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.
- Implant stability, early healing phase [ Time Frame: 3 days postoperatively ]See description for "Implant stability, day of surgery".
- Implant stability, early healing phase [ Time Frame: 7 days postoperatively ]See description for "Implant stability, day of surgery".
- Implant stability, early healing phase [ Time Frame: 10 days postoperatively ]See description for "Implant stability, day of surgery".
- Implant stability, loading of implant [ Time Frame: 14 days postoperatively ]See description for "Implant stability, day of surgery".
- Soft tissue status [ Time Frame: 3 days postoperatively ]
The status of the soft tissue around the abutment shall be assessed using the classification proposed by Holgers et al, referred to as Holgers Index. See scale below:
Grade 0 No irritation. Epidermal debris removed if present. Grade 1 Slight redness. Temporary local treatment. Grade 2 Red and slightly moist tissue. No granulation formation. Local treatment, extra controls.
Grade 3 Reddish and moist. Sometimes granulation tissue. Revision surgery is indicated.
Grade 4 Removal of skin-penetrating implant or abutment necessary due to infection.
Grade R Removal of implant for reasons not related to skin problems.
- Soft tissue status [ Time Frame: 7 days postoperatively ]See "Soft tissue status" - 3 days postoperatively
- Soft tissue status [ Time Frame: 10 days postoperatively ]See "Soft tissue status" - 3 days postoperatively.
- Soft tissue status [ Time Frame: 14 days postoperatively ]See "Soft tissue status" - 3 days postoperatively.
- Soft tissue status [ Time Frame: 21 days postoperatively ]See "Soft tissue status" - 3 days postoperatively.
- Soft tissue status [ Time Frame: 30 days postoperatively ]See "Soft tissue status" - 3 days postoperatively.
- Soft tissue status [ Time Frame: 60 days postoperatively ]See "Soft tissue status" - 3 days postoperatively.
- Soft tissue status [ Time Frame: 180 days postoperatively ]See "Soft tissue status" - 3 days postoperatively.
- Soft tissue status [ Time Frame: 1 year postoperatively ]See "Soft tissue status" - 3 days postoperatively.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome: Same as current
Information By: Aarhus University Hospital
Dates:
Date Received: September 25, 2012
Date Started: August 2012
Date Completion:
Last Updated: January 13, 2015
Last Verified: January 2015
- Implant stability, day of surgery [ Time Frame: Day of surgery ]
