Trial Outcomes & Findings for Bone Level Tapered Multi-Center Study (NCT NCT02569671)

Last Updated: 2025-07-08

Results Overview

mean crestal bone level at 12 months - mean crestal bone level at implant loading (baseline) = Change in crestal bone level

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

53 participants

Primary outcome timeframe

Measured at implant loading (10-12 weeks after implant surgery) and 12 months post-loading

Results posted on

2025-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	Immediate Placement - Test Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth. Straumann Bone Level Tapered Implant - Immediate Placement: Immediate placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth.	Delayed Placement - Control Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth. Straumann Bone Level Tapered Implant - Delayed Placement: Delayed placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth.
Overall Study STARTED	26	27
Overall Study COMPLETED	23	23
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Immediate Placement - Test Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth. Straumann Bone Level Tapered Implant - Immediate Placement: Immediate placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth.	Delayed Placement - Control Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth. Straumann Bone Level Tapered Implant - Delayed Placement: Delayed placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth.
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	1	3

Baseline Characteristics

Bone Level Tapered Multi-Center Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immediate Placement - Test n=26 Participants Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth.	Delayed Placement - Control n=27 Participants Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth.	Total n=53 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Continuous Age	54.5 Years STANDARD_DEVIATION 13.7 • n=5 Participants	57.0 Years STANDARD_DEVIATION 15.0 • n=7 Participants	55.8 Years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	20 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	27 participants n=7 Participants	53 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at implant loading (10-12 weeks after implant surgery) and 12 months post-loading

Population: 65 subjects were screened, 11 were screen failures and 1 pre-randomizatio lost to follow-up. From the 53 subjects randomized (ITT group), 50 subjects (25 in the test, 25 in the control group) received the study treatment (mITT). Among mITT group, 5 lacked primary analysis measurements: 3 control, 2 test. Test group (N=23) had 1 lost follow-up, 1 lost implant post-op. Control group (N=22) had 1 baseline measurement missing, 2 lost implants post-restoration.

mean crestal bone level at 12 months - mean crestal bone level at implant loading (baseline) = Change in crestal bone level

Outcome measures

Outcome measures
Measure	Immediate Placement (Test Group) n=23 Participants Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth.	Delayed Placement (Control Group) n=22 Participants Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth.
Mean Crestal Bone Level Change	0.5 Change in Mean crestal bone levels (mm) Standard Deviation 0.6	0.5 Change in Mean crestal bone levels (mm) Standard Deviation 0.7

SECONDARY outcome

Timeframe: 12 months post-loading

Population: 65 subjects were screened, 11 were screen failures and 1 pre-randomizatio lost to follow-up. From the 53 subjects randomized (ITT group), 50 subjects received the study treatment (mITT). Test group (N=24) had 1 lost follow-up Control group (N=25)

Control group N-25 Test group N=24 Survival and success was assessed by the dimensions below as noted by Buser. * Absence of persistent subjective complaints, such as pain, foreign body sensation, and/ or dysesthesia * Absence of a recurrent peri-implant infection with suppuration * Absence of mobility * Absence of a continuous radiolucency around the implant

Outcome measures

Outcome measures
Measure	Immediate Placement (Test Group) n=24 Participants Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth.	Delayed Placement (Control Group) n=25 Participants Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth.
Implant Success and Survival Lost Implant	1 Participants	2 Participants
Implant Success and Survival surviving and successful implant at 12 months	23 Participants	23 Participants

SECONDARY outcome

Timeframe: Measured at Implant loading and at screening and 12 months post-loading

Population: At Implant Loading - Test group N=23, Control N=23 At 12 month Follow Up - Test group N=22, Control N=23

Buccal bone dimensional changes were measured on images recorded on cone beam computed tomography (CBCT). The average of the following measurement locations is reported as outcome variable: 1\) mesial to distal; 2) distal-buccal; 3) mid-buccal; 4) mesial-buccal; 5) distal-lingual; 6) mid-lingual; 7) mesial-lingual.

Outcome measures

Outcome measures
Measure	Immediate Placement (Test Group) n=22 Participants Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth.	Delayed Placement (Control Group) n=22 Participants Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth.
Buccal Bone Dimensional Changes Mean Buccal Bone Dimensional Change at Implant loading	2.1 mm Standard Deviation 0.6	2.0 mm Standard Deviation 0.5
Buccal Bone Dimensional Changes Mean Buccal Bone Dimensional Change at 12 months post loading	2.1 mm Standard Deviation 0.7	1.8 mm Standard Deviation 0.6

SECONDARY outcome

Timeframe: Implant surgery: Immediate Placement for Test Group = implant is placed at the time of tooth extraction. Delayed Placement is Control Group= implant is placed after 16-18 weeks of healing

Population: Implant stability was measured by resonance frequency analysis implant surgery. 25 subject from each group (control and test) received an implant and had ISQ assessed.

Implant stability as measured by ISQ held facial-lingual and held mesial-lingual. An Osstell device that uses the Resonance Frequency Analysis (RFA) method to determine implant stability and osseointegration was used in the study. The results were presented as an Implant Stability Quotient (ISQ) value of 1 - 100. The higher the ISQ, the more stable the implant. Additional information about the Osstell device can be found at www.osstell.com. Instructions on taking the measurements for this protocol will be provided in the Operation Manual. Two measurements were taken from two different angles at implant placement, implant loading, and final restoration.

Outcome measures

Outcome measures
Measure	Immediate Placement (Test Group) n=25 Participants Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth.	Delayed Placement (Control Group) n=25 Participants Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth.
Implant Measure as Measured by ISQ at Implant Surgery ISQ Value 1: Probe held facial-lingual · ISQ < 60	9 Participants	0 Participants
Implant Measure as Measured by ISQ at Implant Surgery ISQ Value 1: Probe held facial-lingual · ISQ 60 to 69	2 Participants	2 Participants
Implant Measure as Measured by ISQ at Implant Surgery ISQ Value 1: Probe held facial-lingual · ISQ ≥ 70	14 Participants	23 Participants
Implant Measure as Measured by ISQ at Implant Surgery ISQ Value 2: Probe held mesial-lingual · ISQ < 60	7 Participants	0 Participants
Implant Measure as Measured by ISQ at Implant Surgery ISQ Value 2: Probe held mesial-lingual · ISQ 60 to 69	4 Participants	1 Participants
Implant Measure as Measured by ISQ at Implant Surgery ISQ Value 2: Probe held mesial-lingual · ISQ ≥ 70	14 Participants	24 Participants

SECONDARY outcome

Timeframe: Implant Loading=implant surgery + 10 weeks (+/-3 weeks)

Population: 23 subjects from Test group and 24 from Control group had ISQ assessed at Implant Loading.

Implant stability was measured by ISQ and probe held facial-lingual and held mesial-lingual. An Osstell device is an instrument that uses the Resonance Frequency Analysis (RFA) method to determine implant stability and osseointegration. The result is presented as an Implant Stability Quotient (ISQ) value of 1 - 100. The higher the ISQ, the more stable the implant. Additional information about the Osstell device can be found at www.osstell.com. Instructions on taking the measurements for this protocol will be provided in the Operation Manual. Two measurements will be taken from two different angles at implant placement, implant loading, and final restoration.

Outcome measures

Outcome measures
Measure	Immediate Placement (Test Group) n=23 Participants Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth.	Delayed Placement (Control Group) n=24 Participants Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth.
Implant Stability as Measured by ISQ at Implant Loading ISQ Value 1 Probe held facial-lingual measured at Implant Loading · ISQ < 60	0 Participants	1 Participants
Implant Stability as Measured by ISQ at Implant Loading ISQ Value 1 Probe held facial-lingual measured at Implant Loading · ISQ 60 to 69	4 Participants	3 Participants
Implant Stability as Measured by ISQ at Implant Loading ISQ Value 1 Probe held facial-lingual measured at Implant Loading · ISQ ≥ 70	19 Participants	20 Participants
Implant Stability as Measured by ISQ at Implant Loading ISQ Value 2: Probe held mesial-lingual measured at Implant Loading · ISQ < 60	0 Participants	1 Participants
Implant Stability as Measured by ISQ at Implant Loading ISQ Value 2: Probe held mesial-lingual measured at Implant Loading · ISQ 60 to 69	4 Participants	3 Participants
Implant Stability as Measured by ISQ at Implant Loading ISQ Value 2: Probe held mesial-lingual measured at Implant Loading · ISQ ≥ 70	19 Participants	20 Participants

SECONDARY outcome

Timeframe: Final Restoration: 10 weeks post-loading (± 2 weeks)

Population: 23 subjects from Test and 24 from Control group had ISQ assessed at Final Restoration visit.

Outcome measures

Outcome measures
Measure	Immediate Placement (Test Group) n=23 Participants Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth.	Delayed Placement (Control Group) n=24 Participants Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth.
Implant Stability as Measured by ISQ at Final Restoration ISQ Value 1: Probe held facial-lingual · ISQ < 60	1 Participants	1 Participants
Implant Stability as Measured by ISQ at Final Restoration ISQ Value 1: Probe held facial-lingual · ISQ 60 to 69	3 Participants	1 Participants
Implant Stability as Measured by ISQ at Final Restoration ISQ Value 1: Probe held facial-lingual · ISQ ≥ 70	19 Participants	22 Participants
Implant Stability as Measured by ISQ at Final Restoration ISQ Value 2: Probe held mesial-lingual · ISQ < 60	0 Participants	1 Participants
Implant Stability as Measured by ISQ at Final Restoration ISQ Value 2: Probe held mesial-lingual · ISQ 60 to 69	2 Participants	1 Participants
Implant Stability as Measured by ISQ at Final Restoration ISQ Value 2: Probe held mesial-lingual · ISQ ≥ 70	21 Participants	22 Participants

SECONDARY outcome

Timeframe: Soft tissue measurements were taken and compared between the test and the control group at final restoration (10 weeks post loading) and 12 months (± 1 month) post implant loading (implant loading=implant surgery + 10 weeks (+/-3 weeks)).

Population: Measurements of soft tissue changes around the implant were recorded at both the time of final restoration (10 weeks post-loading) and the 12-month Follow-up (12 months post-loading). Specifically, 23 subjects from the Test group and 23 from the Control group had their soft tissue measurements changes assessed at 12 months follow-up (post-loading).

The following table illustrates a comparison between Soft Tissue Mean Changes Around the Implant for delayed and immediate placements, measured at final restoration (10 weeks post loading) and the 12-month mark post implant loading. The parameters assessed included: CLTm (length of crown from highest point of soft tissue to incisal edge of the adjacent mesial tooth), CLTd (length of crown from highest point of soft tissue to incisal edge of the adjacent distal tooth), CLI (length of the implant crown from highest point of the soft tissue margin to the incisal edge), IPm (distance from the top of the papilla to the incisal edge mesial of the implant crown), IPd (distance from the top of the papilla to the incisal edge distal of the implant crown)

Outcome measures

Outcome measures
Measure	Immediate Placement (Test Group) n=23 Participants Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth.	Delayed Placement (Control Group) n=23 Participants Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth.
Change in Soft Tissue Measurements Change in CLTm from final restoration to 12-month follow-up (mm)	-0.3 mm Standard Deviation 1.9	0.1 mm Standard Deviation 0.8
Change in Soft Tissue Measurements Change in CLTd from final restoration to 12-month follow-up (mm)	-0.2 mm Standard Deviation 2.2	0.1 mm Standard Deviation 1.1
Change in Soft Tissue Measurements Change in CLI from final restoration to 12-month follow-up (mm)	-0.4 mm Standard Deviation 1.8	-0.1 mm Standard Deviation 0.8
Change in Soft Tissue Measurements Change in IPm from final restoration to 12-month follow-up (mm)	-0.5 mm Standard Deviation 1.2	-0.5 mm Standard Deviation 1.5
Change in Soft Tissue Measurements Change in IPd from final restoration to 12-month follow-up (mm)	-0.7 mm Standard Deviation 1.6	-0.7 mm Standard Deviation 1.6

SECONDARY outcome

Timeframe: 12 months post-loading

Population: In each group, Test and Control, 25 subjects underwent implant placement, and Subject satisfaction related to pain, crown's esthetic, and crown's function was assessed using Visual Analog Scales (VAS). Specifically, 23 subjects from the Test group and 23 from the Subject satisfaction related to pain, crown's esthetic, and crown's function was assessed at 12 months post-loading using Visual Analog Scales (VAS).

Subject satisfaction related to pain, crown's esthetic, and crown's function was assessed at 12 months post-loading using Visual Analog Scales (VAS). Satisfaction range between 0 to 100 with Excruciating and Not satisfied at all at zero point and Nonexistent and Extremely satisfied at the 100 point. The table summarizes pain, satisfaction with function and satisfaction with esthetics at 12-months post loading.

Outcome measures

Outcome measures
Measure	Immediate Placement (Test Group) n=23 Participants Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth.	Delayed Placement (Control Group) n=23 Participants Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth.
Subject Satisfaction Pain associated with implant crown	5.9 score on a scale Standard Deviation 20.6	14.7 score on a scale Standard Deviation 33.8
Subject Satisfaction Satisfaction with function	97.9 score on a scale Standard Deviation 5.2	97.8 score on a scale Standard Deviation 6.6
Subject Satisfaction Satisfaction with esthetics	96.5 score on a scale Standard Deviation 6.1	96.3 score on a scale Standard Deviation 9.2

SECONDARY outcome

Timeframe: Measured at each study visit and throughout 12 months

Population: Over a 12-month period, 38 adverse events (AEs) were reported among 18 of the 53 study subjects. The randomization process assigned 26 subjects to the test group (=immediate placement) and 27 subjects to the control group (=delayed placement). No serious adverse events (SAEs) related to the procedure or device were observed.

The frequency of adverse events and adverse device effects will be determined at 12 months post-loading and compared between the test and control arms. There were 38 total Adverse Events in 18 subjects out of 53 subjects. There were no SAEs related to procedure or device.

Outcome measures

Outcome measures
Measure	Immediate Placement (Test Group) n=26 Participants Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth.	Delayed Placement (Control Group) n=27 Participants Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth.
Number of Participants With Adverse Events and Adverse Device Effects Over 12 Months Any Adverse Events	6 Participants	12 Participants
Number of Participants With Adverse Events and Adverse Device Effects Over 12 Months Adverse Device Effects	2 Participants	4 Participants
Number of Participants With Adverse Events and Adverse Device Effects Over 12 Months Device Related	1 Participants	2 Participants
Number of Participants With Adverse Events and Adverse Device Effects Over 12 Months Procedure Related	2 Participants	3 Participants
Number of Participants With Adverse Events and Adverse Device Effects Over 12 Months Serious Adverse Events	2 Participants	4 Participants
Number of Participants With Adverse Events and Adverse Device Effects Over 12 Months Serious Adverse Device Events	0 Participants	0 Participants
Number of Participants With Adverse Events and Adverse Device Effects Over 12 Months SAE Device Related	0 Participants	0 Participants
Number of Participants With Adverse Events and Adverse Device Effects Over 12 Months SAE Procedure Related	0 Participants	0 Participants

Adverse Events

Immediate Placement (= Test Group)

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Delayed Placement (= Control Group)

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Immediate Placement (= Test Group) n=26 participants at risk 26 Immediate Placement (= Test Group)	Delayed Placement (= Control Group) n=27 participants at risk 27 Delayed Placement (= Control Group)
Gastrointestinal disorders Chest Pains	3.8% 1/26 • Number of events 1 • For the avoidance of doubt, all AE/SAEs as defined below, regardless of whether they are related to the investigational device, were collected , fully investigated and documented in the source document and appropriate case report form for all subjects from the time of the signing of the informed consent until the 60 months (post-loading) follow-up visit. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in subjects. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.	0.00% 0/27 • For the avoidance of doubt, all AE/SAEs as defined below, regardless of whether they are related to the investigational device, were collected , fully investigated and documented in the source document and appropriate case report form for all subjects from the time of the signing of the informed consent until the 60 months (post-loading) follow-up visit. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in subjects. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.
Musculoskeletal and connective tissue disorders Right knee replacement	0.00% 0/26 • For the avoidance of doubt, all AE/SAEs as defined below, regardless of whether they are related to the investigational device, were collected , fully investigated and documented in the source document and appropriate case report form for all subjects from the time of the signing of the informed consent until the 60 months (post-loading) follow-up visit. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in subjects. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.	3.7% 1/27 • Number of events 1 • For the avoidance of doubt, all AE/SAEs as defined below, regardless of whether they are related to the investigational device, were collected , fully investigated and documented in the source document and appropriate case report form for all subjects from the time of the signing of the informed consent until the 60 months (post-loading) follow-up visit. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in subjects. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.
Respiratory, thoracic and mediastinal disorders Bacterial Pneumonia	3.8% 1/26 • Number of events 1 • For the avoidance of doubt, all AE/SAEs as defined below, regardless of whether they are related to the investigational device, were collected , fully investigated and documented in the source document and appropriate case report form for all subjects from the time of the signing of the informed consent until the 60 months (post-loading) follow-up visit. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in subjects. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.	0.00% 0/27 • For the avoidance of doubt, all AE/SAEs as defined below, regardless of whether they are related to the investigational device, were collected , fully investigated and documented in the source document and appropriate case report form for all subjects from the time of the signing of the informed consent until the 60 months (post-loading) follow-up visit. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in subjects. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.
Gastrointestinal disorders Colon Cancer	0.00% 0/26 • For the avoidance of doubt, all AE/SAEs as defined below, regardless of whether they are related to the investigational device, were collected , fully investigated and documented in the source document and appropriate case report form for all subjects from the time of the signing of the informed consent until the 60 months (post-loading) follow-up visit. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in subjects. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.	3.7% 1/27 • Number of events 1 • For the avoidance of doubt, all AE/SAEs as defined below, regardless of whether they are related to the investigational device, were collected , fully investigated and documented in the source document and appropriate case report form for all subjects from the time of the signing of the informed consent until the 60 months (post-loading) follow-up visit. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in subjects. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.
Musculoskeletal and connective tissue disorders Hernia surgery	0.00% 0/26 • For the avoidance of doubt, all AE/SAEs as defined below, regardless of whether they are related to the investigational device, were collected , fully investigated and documented in the source document and appropriate case report form for all subjects from the time of the signing of the informed consent until the 60 months (post-loading) follow-up visit. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in subjects. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.	3.7% 1/27 • Number of events 1 • For the avoidance of doubt, all AE/SAEs as defined below, regardless of whether they are related to the investigational device, were collected , fully investigated and documented in the source document and appropriate case report form for all subjects from the time of the signing of the informed consent until the 60 months (post-loading) follow-up visit. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in subjects. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.
Cardiac disorders Aortic valve replacement	0.00% 0/26 • For the avoidance of doubt, all AE/SAEs as defined below, regardless of whether they are related to the investigational device, were collected , fully investigated and documented in the source document and appropriate case report form for all subjects from the time of the signing of the informed consent until the 60 months (post-loading) follow-up visit. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in subjects. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.	3.7% 1/27 • Number of events 1 • For the avoidance of doubt, all AE/SAEs as defined below, regardless of whether they are related to the investigational device, were collected , fully investigated and documented in the source document and appropriate case report form for all subjects from the time of the signing of the informed consent until the 60 months (post-loading) follow-up visit. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in subjects. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.
Infections and infestations E. Coli	0.00% 0/26 • For the avoidance of doubt, all AE/SAEs as defined below, regardless of whether they are related to the investigational device, were collected , fully investigated and documented in the source document and appropriate case report form for all subjects from the time of the signing of the informed consent until the 60 months (post-loading) follow-up visit. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in subjects. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.	3.7% 1/27 • Number of events 1 • For the avoidance of doubt, all AE/SAEs as defined below, regardless of whether they are related to the investigational device, were collected , fully investigated and documented in the source document and appropriate case report form for all subjects from the time of the signing of the informed consent until the 60 months (post-loading) follow-up visit. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in subjects. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.
Musculoskeletal and connective tissue disorders Knee replacement	0.00% 0/26 • For the avoidance of doubt, all AE/SAEs as defined below, regardless of whether they are related to the investigational device, were collected , fully investigated and documented in the source document and appropriate case report form for all subjects from the time of the signing of the informed consent until the 60 months (post-loading) follow-up visit. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in subjects. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.	3.7% 1/27 • Number of events 1 • For the avoidance of doubt, all AE/SAEs as defined below, regardless of whether they are related to the investigational device, were collected , fully investigated and documented in the source document and appropriate case report form for all subjects from the time of the signing of the informed consent until the 60 months (post-loading) follow-up visit. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in subjects. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.

Other adverse events

Additional Information

Mustapha El Amrani

Institut Straumann

Phone: 0041619651741

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place