Primairy objective:To compare the incidence of inflammation between the test group (MIPS technique using an Oticon Medical Ponto abutment and implant) and control group ( Hultcrantz technique using an Oticon Medical Ponto abutment and implant) after…
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint will be the incidence of inflammation. Incidence of
inflammation is calculated as the sum of patients with one or more observations
of Holgers index of 2 or higher between surgery and 3 months post-surgery.
Secondary outcome
After 3 months post-surgery
- Presence of dehiscence after surgery
- VAS pain scale >6
- Loss of sensibility
- Soft tissue overgrowth
- Extrusion rate
- ISQ measurments
- Skin position
- Dynamic skin motion
- Surgical time
- Wound healing time
After 24 months post-surgery
- Holgers index of two or higher at any timepoint
- Presence of dehiscence after surgery
- VAS pain scale >6
- Loss of sensibility
- Soft tissue overgrowth
- Extrusion rate
- ISQ measuremnts
- Cosmetic result
Background summary
1 Clinical experience with Ponto
Bone conduction implants (BCI) such as the Ponto® system were first clinically
described in 1977 by Tjellström et al., and since then more than 120.000
patients have been treated with this technique. The Ponto system consists of a
titanium implant, which is integrated with the bone tissue of the skull and is
connected to an external sound processor via a skin penetrating abutment. The
sound processor transforms sound to vibrations that are transmitted via the
abutment and titanium implant to the skull bone and then to the cochlea. This
provides hearing amplification for patients who experience profound hearing
loss for various reasons and who are unable to benefit from a conventional
hearing aid.
2 The surgical procedure
There are a few different surgical techniques to implant the Ponto system. The
common technique used today is to make an incision next to the implant-position
and prepare the right position for the implant from this opening for the Ponto
system. With a *punch* through the skin above the implant-site to expose the
abutment. The original incision will be closed using sutures. With the new
operationtechnique the entire procedure will be done through the punch opening.
Therefore making the original incision obsolete.
Study objective
Primairy objective:
To compare the incidence of inflammation between the test group (MIPS technique
using an Oticon Medical Ponto abutment and implant) and control group (
Hultcrantz technique using an Oticon Medical Ponto abutment and implant) after
3 months post-surgery
Secundairy objectives
To compare performance indicators between the MIPS technique and Hultcrantz
technique
- Presence of dehiscence after surgery
- Pain
- Loss of sensibility
- Soft tissue overgrowth
- Extrusion
- Surgical procedure time
- Wound healing
- ISQ values
To evaluete it the skin position and movement of the skin around the abutment
are affected by the surgical technique (MIPS technique and Hultcrantz technique)
Tertiary objectives:
- To validate the Holgers index
- To assess the correlation between the Holgers index and biological markers
such as cytokines and the bacterial profile on the abutment, in and on the skin
- To collect data for a full economic evaluation
- To develop a peri-implant dermatitis scale and compare it to the Holgers
index.
- To compare the quality of lift after surgery between the MIPS techniqe and
the Hultcrantz technique
Study design
An national single center, open, randomised, comparative, parallel group,
prospective clinical investigation. 1 year investigation with a 2 year
follow-up
Intervention
The surgical placement (conventional versus the investigational surgical
technique) of the Ponto-system
Study burden and risks
1. Burden
The extra burden for patients in participating in this study is minimal and
consists mainly out of the completion of multiple questionnaires and an
investment of time over a period of 3 years. 3 months after the operation we
will collect a small tissue sample from the region around the abutment. This
will take place on a regular control-moment using a micro-biopsy punch and the
burden is comparable with a regular vena punction.
2. Risks
There are no foreseeable additional risks (when compared to the conventional
Ponto procedure) for patients in participating in this study. Bone anchored
hearing devices have been implanted for over 35 years now. The simplified
surgical technique is already being put to practice in several clinics around
the world and clinical studies have deemed it safe. The product has been
certified with a CE marking. The risks of the micro biopsy punch are comparable
with a venapunction. Namely, a bleeding, hematoma, local pain and local
redness.
Datavagen 37B 2
Askim SE-436 32
SE
Datavagen 37B 2
Askim SE-436 32
SE
Listed location countries
Age
Inclusion criteria
• Adult patient, i.e. >= 18 years of age
• Eligible for the Ponto system
• Signed informed consent
Exclusion criteria
A potential subject who meets the inclusion criteria for Ponto surgery, is willing to participate in the trial and meets any of the following criteria will be excluded from participation in this study.
- Known history of immunosuppressive disease
- Use of systemic immunosuppressive medication
- Receiving bilateral bone anchored hearing system
- Relevant dermatological diseases as judged by the investigator
- Not being able to finish the study, for example because of failure to complete the questionnaires
- Participating in another study with medical aids or medication
- When there is no suitable implantation-site for the 4 mm implant during surgery because of insufficient bone quality.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50072.068.14 |