Trial Outcomes & Findings for Zolidd One ExHex Dental Implant Compared to Uncoated One ExHex Dental Implant in Subjects With Partial Edentulism (NCT NCT03283241)
NCT ID: NCT03283241
Last Updated: 2022-03-22
Results Overview
The primary objective is to compare the mean change in stability at 12 weeks minus value at baseline (day 1)after surgery of the "index implant" between coated and uncoated implants. An ISQ (Implant Stability Quotient) probe is used to measure the stability of the implant ISQ (Implant Stability Quotient) scale is 1-100 1 No stability 100 stability The aim is to get as close to a 100 as possible
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-03-22
Participant Flow
Sixty two patient started the study
Unit of analysis: Implants
Participant milestones
| Measure |
Zolidd One ExHex
Coated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
One ExHex
Uncoated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
|---|---|---|
|
Overall Study
STARTED
|
32 57
|
30 49
|
|
Overall Study
Completed 12 Weeks
|
29 50
|
29 48
|
|
Overall Study
COMPLETED
|
28 44
|
27 47
|
|
Overall Study
NOT COMPLETED
|
4 13
|
3 2
|
Reasons for withdrawal
| Measure |
Zolidd One ExHex
Coated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
One ExHex
Uncoated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Subject relocated to Finland
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Zolidd One ExHex
n=32 Participants
Coated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
One ExHex
n=30 Participants
Uncoated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 14.0 • n=32 Participants
|
60.7 years
STANDARD_DEVIATION 12.4 • n=30 Participants
|
58.5 years
STANDARD_DEVIATION 13.3 • n=62 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=32 Participants
|
15 Participants
n=30 Participants
|
31 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=32 Participants
|
15 Participants
n=30 Participants
|
31 Participants
n=62 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Sweden
|
32 participants
n=32 Participants
|
30 participants
n=30 Participants
|
62 participants
n=62 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: At 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex
The primary objective is to compare the mean change in stability at 12 weeks minus value at baseline (day 1)after surgery of the "index implant" between coated and uncoated implants. An ISQ (Implant Stability Quotient) probe is used to measure the stability of the implant ISQ (Implant Stability Quotient) scale is 1-100 1 No stability 100 stability The aim is to get as close to a 100 as possible
Outcome measures
| Measure |
Zolidd One ExHex
n=29 Participants
Coated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
One ExHex
n=29 Participants
Uncoated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
|---|---|---|
|
Change in Stability at 12 Weeks Minus Value at Baseline (Day 1) Comparing Coated and Uncoated Implants Change in Stability From Day 1(Implantation to 12 Weeks After Implantation of the "Index Implant" Comparing Coated and Uncoated Implants
|
7.47 ISQ (Implant Stability Quotient) score
Standard Deviation 25.71
|
2.83 ISQ (Implant Stability Quotient) score
Standard Deviation 16.71
|
SECONDARY outcome
Timeframe: week 8 and week 12Population: At 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex
To compare absolute ISQ (Implant Stability Quotient) highest values between coated and uncoated "index implants" at week 8 and week 12 after implantation An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100 1 No stability 100 stability Aim its to get close to 100
Outcome measures
| Measure |
Zolidd One ExHex
n=32 Participants
Coated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
One ExHex
n=30 Participants
Uncoated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
|---|---|---|
|
To Compare Absolute ISQ (Implant Stability Quotient) Highest Values Between Coated and Uncoated Implants for the "Index Implant" at Week 8 and Week 12
week 8
|
83 ISQ Score
|
85 ISQ Score
|
|
To Compare Absolute ISQ (Implant Stability Quotient) Highest Values Between Coated and Uncoated Implants for the "Index Implant" at Week 8 and Week 12
week 12
|
84 ISQ Score
|
85 ISQ Score
|
SECONDARY outcome
Timeframe: Day1 to week 12Population: This is the Adverse Event (AE) that has been reported and will be presented in the AE table under product issues, this is devices that failed and/or lossened At 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex
To compare safety as assessed by complications post-surgery and any other adverse event up to week 12 between all coated and all uncoated implants
Outcome measures
| Measure |
Zolidd One ExHex
n=29 Participants
Coated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
One ExHex
n=29 Participants
Uncoated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
|---|---|---|
|
Incidence of Post-surgery Complications and Adverse Events
|
5 Number of events reported
|
4 Number of events reported
|
SECONDARY outcome
Timeframe: Day 1 to week 8Population: In the Zolidd One ExHex 3 subjects have missing information. In the One ExHex group 1 subject have missing information at week 8 and 12.
To compare change in stability from day 1 to week 8 between the coated and the uncoated "index implants" An ISQ (Implant Stability Quotient) probe is used to measure the stability of the implant ISQ (Implant Stability Quotient) scale is 1-100 1 No stability 100 stability The aim is to get as close to a 100 as possible
Outcome measures
| Measure |
Zolidd One ExHex
n=29 Participants
Coated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
One ExHex
n=29 Participants
Uncoated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
|---|---|---|
|
Change in ISQ (Implant Stability Quotient) Highest Value for the "Index Implant"
|
4.34 ISQ Score
Standard Deviation 10.83
|
1.38 ISQ Score
Standard Deviation 8.86
|
SECONDARY outcome
Timeframe: week 8 and week 12Population: At 8 and 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex
To compare change in stability from day 1 to week 8 and 12 between all other coated and all other uncoated implants An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100 1 No stability 100 stability
Outcome measures
| Measure |
Zolidd One ExHex
n=50 Implants
Coated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
One ExHex
n=49 Implants
Uncoated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
|---|---|---|
|
Change in ISQ Highest Value for All Other Implants
week 8
|
9.0 ISQ Score
Standard Deviation 21.6
|
5.1 ISQ Score
Standard Deviation 20.1
|
|
Change in ISQ Highest Value for All Other Implants
week 12
|
7.1 ISQ Score
Standard Deviation 22.2
|
3.7 ISQ Score
Standard Deviation 20.4
|
SECONDARY outcome
Timeframe: Week 8 and 12Population: At 8 and 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex
To compare absolute ISQ (Implant Stability Quotient) highest value at week 8 and 12 between all other coated and all other uncoated implants An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100 1 No stability 100 stability
Outcome measures
| Measure |
Zolidd One ExHex
n=50 Implants
Coated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
One ExHex
n=49 Implants
Uncoated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
|---|---|---|
|
Absolute ISQ (Implant Stability Quotient) Highest Value for All Other Implants
week 8
|
83 ISQ Score
|
85 ISQ Score
|
|
Absolute ISQ (Implant Stability Quotient) Highest Value for All Other Implants
week 12
|
84 ISQ Score
|
85 ISQ Score
|
SECONDARY outcome
Timeframe: week 8 and 12Population: At 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex
To compare change in marginal bone height between all coated and all uncoated implants from at week 8 and 12 The marginal bone height is measured by x-ray and measuring the distance between the implant and bone in mm (millimeter)
Outcome measures
| Measure |
Zolidd One ExHex
n=29 Participants
Coated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
One ExHex
n=29 Participants
Uncoated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
|---|---|---|
|
Change in Marginal Bone Height for All Other Implants
Week 8 Mesial
|
0.3 mm(milimeter)
Standard Deviation 0.7
|
0.2 mm(milimeter)
Standard Deviation 0.5
|
|
Change in Marginal Bone Height for All Other Implants
Week 8 Distal
|
0.4 mm(milimeter)
Standard Deviation 0.8
|
0.2 mm(milimeter)
Standard Deviation 0.4
|
|
Change in Marginal Bone Height for All Other Implants
Week 12 Mesial
|
0.5 mm(milimeter)
Standard Deviation 0.5
|
0.4 mm(milimeter)
Standard Deviation 0.7
|
|
Change in Marginal Bone Height for All Other Implants
Week 12 Distal
|
0.6 mm(milimeter)
Standard Deviation 1.0
|
0.4 mm(milimeter)
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: month 24Population: See adverse events, all implant loss is reported as adverse events
To compare safety as assessed by complications post-surgery and other adverse events up to month 24 post-implantation visit between all coated and all uncoated implants
Outcome measures
| Measure |
Zolidd One ExHex
n=32 Participants
Coated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
One ExHex
n=30 Participants
Uncoated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
|---|---|---|
|
Post-surgical Complications and Other Adverse Events (AEs) for All Implants
|
4 Number of events reported
|
1 Number of events reported
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: At 24 month 4 subjects have missing data in Zolidd One ExHex (28 subjects) and 3 subjects have missing data in One ExHex (27 subjects)
To compare survival rate of implants up to 24 months between all coated and all uncoated implants
Outcome measures
| Measure |
Zolidd One ExHex
n=44 Implants
Coated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
One ExHex
n=47 Implants
Uncoated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
|---|---|---|
|
Survival Rate for All Implants
|
0.930 Number of implant loss
Interval 0.824 to 0.973
|
0.939 Number of implant loss
Interval 0.822 to 0.98
|
SECONDARY outcome
Timeframe: Day 1, month 12 and 24Population: At 12 weeks 3 subjects have missing data in Zolidd One ExHex (29 subjects) and 1 subject have missing data in One ExHex (29 subjects) At 24 month 4 subjects have missing data in Zolidd One ExHex (28 subjects) and 3 subjects have missing data in One ExHex (27 subjects)
To compare change in marginal bone height from day 1 to month 12 and 24 between all coated and all uncoated implants The marginal bone height is measured by x-ray and measuring the distance between the implant and bone in mm (millimeter)
Outcome measures
| Measure |
Zolidd One ExHex
n=32 Participants
Coated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
One ExHex
n=30 Participants
Uncoated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
|---|---|---|
|
Change in Marginal Bone Height for All Implants
Week 12 Mesial
|
0.5 mm(millimeter)
Standard Deviation 0.8
|
0.3 mm(millimeter)
Standard Deviation 0.6
|
|
Change in Marginal Bone Height for All Implants
Week 12 Distal
|
0.5 mm(millimeter)
Standard Deviation 0.9
|
0.3 mm(millimeter)
Standard Deviation 0.6
|
|
Change in Marginal Bone Height for All Implants
Month 24 Mesial
|
0.5 mm(millimeter)
Standard Deviation 1.0
|
0.5 mm(millimeter)
Standard Deviation 1.0
|
|
Change in Marginal Bone Height for All Implants
Month 24 Distal
|
0.5 mm(millimeter)
Standard Deviation 1.0
|
0.5 mm(millimeter)
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Month 12 and 24Population: At 12 and 24 month 4 subjects have missing data in Zolidd One ExHex (28 subjects) and 3 subjects have missing data in One ExHex (27 subjects)
To compare peri-implantitis frequency at 12 and 24 months between all coated and all uncoated implants Ocular assessment of redness and swelling this is an overall judgement of peri-implantitis
Outcome measures
| Measure |
Zolidd One ExHex
n=32 Participants
Coated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
One ExHex
n=30 Participants
Uncoated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
|---|---|---|
|
Occurrence of Signs Associated With Peri-implantitis for All Implants
12 month
|
0 number of participants redness/swollen
|
0 number of participants redness/swollen
|
|
Occurrence of Signs Associated With Peri-implantitis for All Implants
24 month
|
0 number of participants redness/swollen
|
0 number of participants redness/swollen
|
Adverse Events
Zolidd One ExHex
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
One ExHex
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zolidd One ExHex
n=32 participants at risk
Coated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
One ExHex
n=30 participants at risk
Uncoated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
|---|---|---|
|
Psychiatric disorders
Bipolar disorder
|
3.1%
1/32 • Number of events 1 • The adverse events were collected from visit 1 to 24 month
|
0.00%
0/30 • The adverse events were collected from visit 1 to 24 month
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/32 • The adverse events were collected from visit 1 to 24 month
|
3.3%
1/30 • Number of events 1 • The adverse events were collected from visit 1 to 24 month
|
Other adverse events
| Measure |
Zolidd One ExHex
n=32 participants at risk
Coated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
One ExHex
n=30 participants at risk
Uncoated titanium implant
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
|
|---|---|---|
|
Product Issues
Device Failure
|
21.9%
7/32 • Number of events 9 • The adverse events were collected from visit 1 to 24 month
|
13.3%
4/30 • Number of events 4 • The adverse events were collected from visit 1 to 24 month
|
|
Musculoskeletal and connective tissue disorders
Back pan
|
0.00%
0/32 • The adverse events were collected from visit 1 to 24 month
|
3.3%
1/30 • Number of events 1 • The adverse events were collected from visit 1 to 24 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60