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Clinical Trials/NCT03807713
NCT03807713CompletedNot Applicable

Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration

Oticon Medical1 site in 1 country25 target enrollmentStarted: September 7, 2018Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
25
Locations
1
Primary Endpoint
Numbness (sensibility) around the implant
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and abutments.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •18 years or older.
  • •Patient indicated for an ear level bone anchored sound processor.
  • •Healthy bone quality to allow for 4mm implant insertion.

Exclusion Criteria

  • •Intraoperative switch to an alternative surgical technique
  • •Patients undergoing re-implantation (on the side being included in the study)
  • •Previous participation in the C47 study.
  • •Inability to participate in follow-up.
  • •Psychiatric disease in the medical history.
  • •Mental disability.
  • •Presumed doubt, for any reason, that the patient will be able to show up on all follow-ups.
  • •Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
  • •Patients with natural skin height of >12mm (as there will be additional skin reduction needed)

Arms & Interventions

Minimally Invasive Ponto Surgery

Other

Surgical method for installation of a bone anchored hearing system for hearing rehabilitation

Intervention: Minimally Invasive Ponto Surgery (Device)

Outcomes

Primary Outcomes

Numbness (sensibility) around the implant

Time Frame: 6 months post surgery

Total numbness around the implant will be assessed as a combination of gnostic and vital sensibility.

Secondary Outcomes

  • Quality of Life Assessment(36 months)
  • Adverse skin reactions(36 months)
  • Implant stability as measured with resonance frequency analysis, RFA.(36 months)
  • Wound dehiscence(36 months)
  • Implant survivability(36 months)
  • Surgical wound healing time(36 months)
  • Length of surgery(At surgery)
  • Pain perception by patient(36 months)
  • Unplanned visits(36 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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