Trial Outcomes & Findings for AMPLEX Ankle Fusion and Hindfoot (NCT NCT03028415)

NCT ID: NCT03028415

Last Updated: 2021-03-11

Results Overview

Proportion of subjects who met all the following criteria for the SPC endpoint at 52 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale \[VAS\]); 2. Absence of significant graft harvest site pain (\<20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 52); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 52). The last observation carried forward was used for subjects with missing response status at 52 weeks.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 56 participants
• Primary outcome timeframe: At week 52
• Results posted on: 2021-03-11

Participant Flow

The trial was conducted at 19 sites (14 sites in the United States and 5 sites in Canada) between July 2017 to July 2020.

A total of 80 subjects were screened in the trial, of which, 56 subjects were randomized. All the 56 randomized subjects were exposed to graft material: 39 subjects were exposed to AMPLEX and 17 subjects were exposed to autogenous bone graft (ABG).

Participant milestones

Measure	AMPLEX AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) Autogenous Bone Graft (ABG): Control material administered by surgical implant
Overall Study STARTED	39	17
Overall Study Modified Intention-to-treat (mITT) Population	39	17
Overall Study COMPLETED	31	14
Overall Study NOT COMPLETED	8	3

Reasons for withdrawal

Measure	AMPLEX AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) Autogenous Bone Graft (ABG): Control material administered by surgical implant
Overall Study Lost to Follow-up	6	3
Overall Study Withdrawal by Subject	1	0
Overall Study Discontinued due to COVID-19	1	0

Baseline Characteristics

AMPLEX Ankle Fusion and Hindfoot

Baseline characteristics by cohort

Measure	AMPLEX n=39 Participants AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) n=17 Participants Autogenous Bone Graft (ABG): Control material administered by surgical implant	Total n=56 Participants Total of all reporting groups
Age, Continuous	55.4 years STANDARD_DEVIATION 12.0 • n=5 Participants	50.5 years STANDARD_DEVIATION 14.4 • n=7 Participants	53.9 years STANDARD_DEVIATION 12.8 • n=5 Participants
Age, Customized <65 years	29 participants n=5 Participants	14 participants n=7 Participants	43 participants n=5 Participants
Age, Customized >=65 years	10 participants n=5 Participants	3 participants n=7 Participants	13 participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	13 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	4 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	16 Participants n=7 Participants	55 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	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	12 Participants n=7 Participants	48 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	10 participants n=7 Participants	29 participants n=5 Participants
Region of Enrollment Canada	20 participants n=5 Participants	7 participants n=7 Participants	27 participants n=5 Participants

PRIMARY outcome

Timeframe: At week 52

Population: The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.

Proportion of subjects who met all the following criteria for the SPC endpoint at 52 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (<20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 52); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 52).

The last observation carried forward was used for subjects with missing response status at 52 weeks.

Outcome measures

Measure	AMPLEX n=39 Participants AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) n=17 Participants Autogenous Bone Graft (ABG): Control material administered by surgical implant
Proportion of Subjects Who Met All Five Criteria for Subject Performance Composite (SPC) Endpoint	79.5 percentage of subjects	35.3 percentage of subjects

SECONDARY outcome

Timeframe: At week 52

Population: The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.

Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.

The last observation carried forward was used for subjects with missing response status at 52 weeks.

Outcome measures

Measure	AMPLEX n=39 Participants AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) n=17 Participants Autogenous Bone Graft (ABG): Control material administered by surgical implant
Proportion of Subjects Achieving Computerized Tomography (CT) Radiographic Fusion Success	66.7 percentage of subjects	82.4 percentage of subjects

SECONDARY outcome

Timeframe: At week 12

Population: The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.

Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.

Outcome measures

Measure	AMPLEX n=38 Participants AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) n=17 Participants Autogenous Bone Graft (ABG): Control material administered by surgical implant
Proportion of Subjects Achieving CT Radiographic Fusion Success	47.4 percentage of subjects	58.8 percentage of subjects

SECONDARY outcome

Timeframe: At week 24

Population: The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.

Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.

Outcome measures

Measure	AMPLEX n=37 Participants AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) n=16 Participants Autogenous Bone Graft (ABG): Control material administered by surgical implant
Proportion of Subjects Achieving CT Radiographic Fusion Success	73.0 percentage of subjects	75.0 percentage of subjects

SECONDARY outcome

Timeframe: Baseline, and at week 12

Population: The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.

Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".

Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure.

Outcome measures

Measure	AMPLEX n=37 Participants AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) n=16 Participants Autogenous Bone Graft (ABG): Control material administered by surgical implant
Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (>20 mm Reduction From Baseline on 100 mm VAS)	78.4 percentage of subjects	68.8 percentage of subjects

SECONDARY outcome

Timeframe: Baseline, and at week 24

Population: The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.

Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".

Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure.

Outcome measures

Measure	AMPLEX n=36 Participants AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) n=16 Participants Autogenous Bone Graft (ABG): Control material administered by surgical implant
Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (>20 mm Reduction From Baseline on 100 mm VAS)	88.9 percentage of subjects	62.5 percentage of subjects

SECONDARY outcome

Timeframe: Baseline, and at week 52

Population: The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.

Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".

Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure.

Outcome measures

Measure	AMPLEX n=32 Participants AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) n=15 Participants Autogenous Bone Graft (ABG): Control material administered by surgical implant
Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (>20 mm Reduction From Baseline on 100 mm VAS)	90.6 percentage of subjects	80.0 percentage of subjects

SECONDARY outcome

Timeframe: At week 2

Population: The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.

Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".

Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure.

Outcome measures

Measure	AMPLEX n=15 Participants AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) Autogenous Bone Graft (ABG): Control material administered by surgical implant
Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS)	33.3 percentage of subjects	—

SECONDARY outcome

Timeframe: At week 6

Population: The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.

Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".

Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure.

Outcome measures

Measure	AMPLEX n=15 Participants AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) Autogenous Bone Graft (ABG): Control material administered by surgical implant
Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS)	60.0 percentage of subjects	—

SECONDARY outcome

Timeframe: At week 12

Population: The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.

Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".

Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure.

Outcome measures

Measure	AMPLEX n=15 Participants AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) Autogenous Bone Graft (ABG): Control material administered by surgical implant
Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS)	73.3 percentage of subjects	—

SECONDARY outcome

Timeframe: At week 24

Population: The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.

Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".

Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure.

Outcome measures

Measure	AMPLEX n=15 Participants AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) Autogenous Bone Graft (ABG): Control material administered by surgical implant
Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS)	60.0 percentage of subjects	—

SECONDARY outcome

Timeframe: At week 52

Population: The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.

Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".

Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure.

Outcome measures

Measure	AMPLEX n=16 Participants AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) Autogenous Bone Graft (ABG): Control material administered by surgical implant
Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS)	68.8 percentage of subjects	—

SECONDARY outcome

Timeframe: Baseline, and at week 12

Population: The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.

Functional improvement was assessed using the Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction.

Outcome measures

Measure	AMPLEX n=37 Participants AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) n=16 Participants Autogenous Bone Graft (ABG): Control material administered by surgical implant
Change From Baseline in FAAM-ADL	11.16 score on a scale Standard Deviation 27.67	7.17 score on a scale Standard Deviation 20.46

SECONDARY outcome

Timeframe: Baseline, and at week 24

Population: The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.

Functional improvement was assessed using the e Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction.

Outcome measures

Measure	AMPLEX n=36 Participants AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) n=16 Participants Autogenous Bone Graft (ABG): Control material administered by surgical implant
Change From Baseline in FAAM-ADL	25.36 score on a scale Standard Deviation 23.82	13.28 score on a scale Standard Deviation 17.30

SECONDARY outcome

Timeframe: Baseline, and at week 52

Population: The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.

Functional improvement was assessed using the Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction.

Outcome measures

Measure	AMPLEX n=32 Participants AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) n=15 Participants Autogenous Bone Graft (ABG): Control material administered by surgical implant
Change From Baseline in FAAM-ADL	34.99 score on a scale Standard Deviation 21.51	11.37 score on a scale Standard Deviation 21.49

SECONDARY outcome

Timeframe: At week 12

Population: The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.

Proportion of subjects who met all the following criteria for the Subject Performance Composite (SPC) endpoint at 12 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (<20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 12); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 12).

Outcome measures

Measure	AMPLEX n=37 Participants AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) n=16 Participants Autogenous Bone Graft (ABG): Control material administered by surgical implant
Subject Performance Composite (SPC) Endpoint	40.5 percentage of subjects	31.3 percentage of subjects

SECONDARY outcome

Timeframe: At week 24

Population: The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.

Proportion of subjects who met all the following criteria for the SPC endpoint at 24 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (<20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 24); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 24).

Outcome measures

Measure	AMPLEX n=36 Participants AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) n=15 Participants Autogenous Bone Graft (ABG): Control material administered by surgical implant
Subject Performance Composite (SPC) Endpoint	66.7 percentage of subjects	6.7 percentage of subjects

SECONDARY outcome

Timeframe: Baseline, and at week 24

Population: The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.

The Short Form-12 (SF-12) Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health (psychological distress and psychological well-being). These eight domain scales were used to derive Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. All scores were calculated through scoring software. Domain scales and component summary scores ranged from 0 to 100, with a higher score considered better.

Outcome measures

Measure	AMPLEX n=36 Participants AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) n=16 Participants Autogenous Bone Graft (ABG): Control material administered by surgical implant
Change From Baseline in Short Form-12 (SF-12) SF-12 Physical component summary (Week 24)	9.1 score on a scale Standard Deviation 11.2	5.3 score on a scale Standard Deviation 7.1
Change From Baseline in Short Form-12 (SF-12) SF-12 Mental component summary (Week 24)	2.0 score on a scale Standard Deviation 12.5	-3.6 score on a scale Standard Deviation 9.2

SECONDARY outcome

Timeframe: Baseline, and at week 52

Population: The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.

The Short Form-12 (SF-12) Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health (psychological distress and psychological well-being). These eight domain scales were used to derive Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. All scores were calculated through scoring software. Domain scales and component summary scores ranged from 0 to 100, with a higher score considered better.

Outcome measures

Measure	AMPLEX n=32 Participants AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) n=15 Participants Autogenous Bone Graft (ABG): Control material administered by surgical implant
Change From Baseline in Short Form-12 (SF-12) SF-12 Physical component summary (Week 52)	10.5 score on a scale Standard Deviation 10.7	3.8 score on a scale Standard Deviation 7.4
Change From Baseline in Short Form-12 (SF-12) SF-12 Mental component summary (Week 52)	4.4 score on a scale Standard Deviation 11.6	-0.8 score on a scale Standard Deviation 11.0

Adverse Events

AMPLEX

Serious events: 7 serious events

Other events: 27 other events

Deaths: 0 deaths

Autogenous Bone Graft (ABG)

Serious events: 7 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	AMPLEX n=39 participants at risk AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) n=17 participants at risk Autogenous Bone Graft (ABG): Control material administered by surgical implant
Eye disorders Cataract	2.6% 1/39 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	0.00% 0/17 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Eye disorders Glaucoma	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Gastrointestinal disorders Abdominal hernia	2.6% 1/39 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	0.00% 0/17 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Gastrointestinal disorders Colitis	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
General disorders Impaired healing	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Hepatobiliary disorders Biliary colic	2.6% 1/39 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	0.00% 0/17 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Hepatobiliary disorders Cholecystitis	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Infections and infestations Candida infection	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Infections and infestations Pyelonephritis	2.6% 1/39 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	0.00% 0/17 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Infections and infestations Sepsis	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Injury, poisoning and procedural complications Overdose	2.6% 1/39 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	0.00% 0/17 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Musculoskeletal and connective tissue disorders Pseudarthrosis	2.6% 1/39 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Renal and urinary disorders Urinary retention	2.6% 1/39 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	0.00% 0/17 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.

Other adverse events

Measure	AMPLEX n=39 participants at risk AMPLEX: A bone graft substitute	Autogenous Bone Graft (ABG) n=17 participants at risk Autogenous Bone Graft (ABG): Control material administered by surgical implant
Blood and lymphatic system disorders Leukocytosis	2.6% 1/39 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Cardiac disorders Tachycardia	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Gastrointestinal disorders Gastrooesophageal reflux disease	7.7% 3/39 • Number of events 3 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Gastrointestinal disorders Nausea	7.7% 3/39 • Number of events 4 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Gastrointestinal disorders Vomiting	5.1% 2/39 • Number of events 2 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Gastrointestinal disorders Large intestine polyp	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	11.8% 2/17 • Number of events 2 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Gastrointestinal disorders Abdominal pain	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Gastrointestinal disorders Haemorrhoids	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
General disorders Oedema peripheral	7.7% 3/39 • Number of events 3 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
General disorders Implant site irritation	2.6% 1/39 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
General disorders Non-cardiac chest pain	2.6% 1/39 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
General disorders Implant site pain	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
General disorders Peripheral swelling	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Infections and infestations Urinary tract infection	2.6% 1/39 • Number of events 3 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	11.8% 2/17 • Number of events 2 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Infections and infestations Acute sinusitis	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Infections and infestations Bronchitis	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Infections and infestations Gastroenteritis	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Infections and infestations Helicobacter infection	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Infections and infestations Herpes simplex	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Infections and infestations Upper respiratory tract infection	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Injury, poisoning and procedural complications Fall	5.1% 2/39 • Number of events 3 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Injury, poisoning and procedural complications Incision site hypoaesthesia	5.1% 2/39 • Number of events 2 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Injury, poisoning and procedural complications Incision site swelling	5.1% 2/39 • Number of events 2 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	0.00% 0/17 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Injury, poisoning and procedural complications Limb injury	5.1% 2/39 • Number of events 2 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	0.00% 0/17 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Injury, poisoning and procedural complications Procedural nausea	2.6% 1/39 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Injury, poisoning and procedural complications Wound dehiscence	5.1% 2/39 • Number of events 2 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	0.00% 0/17 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Injury, poisoning and procedural complications Eschar	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Injury, poisoning and procedural complications Procedural vomiting	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Investigations Gamma-glutamyltransferase increased	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Investigations White blood cell count decreased	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 2 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 2 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Musculoskeletal and connective tissue disorders Arthralgia	5.1% 2/39 • Number of events 2 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	17.6% 3/17 • Number of events 3 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Musculoskeletal and connective tissue disorders Back pain	5.1% 2/39 • Number of events 2 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	11.8% 2/17 • Number of events 2 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Musculoskeletal and connective tissue disorders Pain in extremity	5.1% 2/39 • Number of events 2 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	11.8% 2/17 • Number of events 3 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Musculoskeletal and connective tissue disorders Plantar fasciitis	5.1% 2/39 • Number of events 2 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Musculoskeletal and connective tissue disorders Osteoarthritis	5.1% 2/39 • Number of events 2 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	0.00% 0/17 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Musculoskeletal and connective tissue disorders Tendonitis	2.6% 1/39 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Nervous system disorders Hypoaesthesia	7.7% 3/39 • Number of events 3 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	0.00% 0/17 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Nervous system disorders Headache	2.6% 1/39 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Nervous system disorders Lumbar radiculopathy	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Nervous system disorders Seizure	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Nervous system disorders Syncope	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Psychiatric disorders Insomnia	2.6% 1/39 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Psychiatric disorders Anxiety	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Renal and urinary disorders Acute kidney injury	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Skin and subcutaneous tissue disorders Skin ulcer	2.6% 1/39 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 2 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/39 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	5.9% 1/17 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Vascular disorders Hypertension	2.6% 1/39 • Number of events 1 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.	11.8% 2/17 • Number of events 2 • From the signing of the informed consent up to 78 weeks A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.

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