Skip to main content
Clinical Trials/NCT01738490
NCT01738490CompletedNot Applicable

Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant

Oticon Medical2 sites in 1 country59 target enrollmentStarted: June 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
59
Locations
2
Primary Endpoint
ISQ (Implant Stability Quotient)

Study Overview

Brief Summary

The overall aim of the study is to investigate the Ponto wide implant considering; initial implant stability, stability over time, skin reaction and long term success when loaded at 3 weeks post surgery. Patients' quality of life improvements following implantation will also be surveyed.

More specifically the primary objective of this clinical study is to test the hypothesis

  • The new Ponto wide diameter implant offers increased implant stability measured as ISQ (implant stability quotient) compared to the previous generation Ponto implant.

And the secondary objective is to

  • Investigate when in time implant stability is the lowest as the initial mechanical stability is gradually replaced by biological stability

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
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
  • Bone thickness at the implant site of at least 4 mm

Exclusion Criteria

  • Longer abutment (>6mm) required
  • 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.

Arms & Interventions

Wide diameter implant

Other

Bone anchored hearing implant For the wide diameter arm (test group), the Ponto wide implant (diameter 4,5mm, length 4mm) and abutment 6mm developed by Oticon Medical AB (Gothenburg, Sweden) will be installed.

Intervention: Bone anchored hearing implant (Device)

Control group

Other

Bone anchored hearing implant For the control group, the previous generation Ponto implant (diameter 3,75mm, length 4mm) and 6mm abutment (Oticon Medical AB, Gothenburg, Sweden) will be installed.

Intervention: Bone anchored hearing implant (Device)

Outcomes

Primary Outcomes

ISQ (Implant Stability Quotient)

Time Frame: 36 months after surgery

Secondary Outcomes

  • Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire(36 months after surgery)
  • Glasgow Health Status Inventory (GHSI) questionnaire(36 months after surgery)
  • ISQ (Implant stability quotient) gradient(0, 7, 14, 21 and 28 days, 6 weeks, 12weeks, 6 months after surgery)
  • Skin condition according to Holgers score(36 months after surgery)
  • Glasgow Benefit Inventory Questionnaire(12 months after surgery)
  • Time of minimum ISQ (Implant stability quotient)(0, 7, 14, 21 and 28 days after surgery)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials