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Completed

NCT Number: NCT03807713

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

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.

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Key information

Conditions

Bone Conduction Deafness Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Mixed Conductive-Sensorineural Hearing Loss, Unilateral Middle Ear Deafness Mixed Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Unilateral Deafness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Medical Center

Nijmegen, 6525, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Minimally Invasive Ponto Surgery

Device

Minimally Invasive Ponto surgery is used for hearing rehabilitation using Ponto Wide Implants in patients indicated and counselled for Bone Anchored Hearing Systems.

Primary outcomes

  1. 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

  1. Length of surgery

    Time frame: At surgery

    Compare the surgical time between test (this investigation) and control group (previous investigation, C47).

  2. Unplanned visits

    Time frame: 36 months

    Investigate and compare the number of unplanned visits, including unplanned surgical procedures and other treatments for the test (this investigation) and control group (previous investigation, C47).

  3. Adverse skin reactions

    Time frame: 36 months

    Investigate and compare the rate of adverse skin reactions using the Holgers Scale.

  4. Adverse skin reactions

    Time frame: 36 months

    Investigate and compare the rate of adverse skin reactions using the IPS scale.

  5. Pain perception by patient

    Time frame: 36 months

    Investigate and compare pain using a visual analogue scale 0-10

  6. Implant survivability

    Time frame: 36 months

    Investigate and compare implant survivability in terms of reported implant loss.

  7. Implant stability as measured with resonance frequency analysis, RFA.

    Time frame: 36 months

    Investigate and compare implant stability.

    Implant stability is monitored by measuring the implant stability quotient when following up on patients. Stability will be reported as implant stability quotient (ISQ).

  8. Surgical wound healing time

    Time frame: 36 months

    Investigate and compare healing time after surgery.

    Follow-up visits after surgery will assess the healing of wound. This will be a yes/no assessment to be answered by the attending physician. The investigators will also evaluate skin reactions and record any medications that were given to aid in skin healing.

  9. Wound dehiscence

    Time frame: 36 months

    Investigate wound dehiscence size after surgery.

  10. Quality of Life Assessment

    Time frame: 36 months

    Investigate and compare subjective benefit as measured by SSQ questionnaire.

  11. Quality of Life Assessment

    Time frame: 36 months

    Investigate and compare subjective benefit as measured by YORK questionnaire.

  12. Quality of Life Assessment

    Time frame: 36 months

    Investigate and compare subjective benefit as measured by APHAB questionnaire.

  13. Quality of Life Assessment

    Time frame: 36 months

    Investigate and compare subjective benefit as measured by GBI questionnaire.

  14. Quality of Life Assessment

    Time frame: 36 months

    Investigate and compare subjective benefit as measured by GHSI questionnaire.

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2022
First posted
Jan 17, 2019
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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