Trial Outcomes & Findings for Trident® Tritanium™ Acetabular Shell Revision Study (NCT NCT00535626)

NCT ID: NCT00535626

Last Updated: 2017-11-20

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

241 participants

Primary outcome timeframe

5 years post-operative

Results posted on

2017-11-20

Participant Flow

241 patients/245 hips - 51 patients/52 hips censored = 190 patients/193 hips followed

Unit of analysis: Hips

Participant milestones

Participant milestones
Measure	Trident® Tritanium™ Acetabular Shell Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
Overall Study STARTED	190 193
Overall Study COMPLETED	85 86
Overall Study NOT COMPLETED	105 107

Reasons for withdrawal

Reasons for withdrawal
Measure	Trident® Tritanium™ Acetabular Shell Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
Overall Study Death	15
Overall Study Lost to Follow-up	29
Overall Study Withdrawal by Subject	20
Overall Study Removal/revision of study component	8
Overall Study Subject terminated	31
Overall Study Unable to return	2

Baseline Characteristics

Trident® Tritanium™ Acetabular Shell Revision Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trident® Tritanium™ Acetabular Shell n=190 Participants Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
Age, Continuous	63.70 years STANDARD_DEVIATION 11.45 • n=5 Participants
Sex: Female, Male Female	85 Participants n=5 Participants
Sex: Female, Male Male	105 Participants n=5 Participants
Region of Enrollment United States	190 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years post-operative

Population: No cases were pending revision.

Outcome measures

Outcome measures
Measure	Trident® Tritanium™ Acetabular Shell n=193 hips Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
Number of Hips Requiring Revision or Pending Revision of the Acetabular Shell (as Defined by Radiographic Parameters) Due to Instability or Lack of Fixation	4 hips

SECONDARY outcome

Timeframe: pre-op, 3 month, 1, 2, 3, 4, 5 years

Population: Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.

The change in HHS is reported by comparing the mean pre-operative, 3-month, 1, 2, 3, 4, and 5 year post-operative scores. Scores can range from 0 to 100, with 0 being the worst and 100 being the best score. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor.

Outcome measures

Outcome measures
Measure	Trident® Tritanium™ Acetabular Shell n=173 hips Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits Mean HHS score 3 years	86.56 units on a scale Standard Deviation 15.40
Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits Mean HHS score 4 years	83.87 units on a scale Standard Deviation 17.32
Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits Mean HHS score 5 years	86.29 units on a scale Standard Deviation 14.43
Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits Mean HHS score preoperative	53.40 units on a scale Standard Deviation 21.99
Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits Mean HHS score 3 months	79.46 units on a scale Standard Deviation 16.58
Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits Mean HHS score 1 year	86.11 units on a scale Standard Deviation 14.83
Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits Mean HHS score 2 years	85.34 units on a scale Standard Deviation 15.60

SECONDARY outcome

Timeframe: pre-op, 3 month, 1, 2, 3, 4, 5 years

Population: Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.

The change in SF-36 is reported by comparing the mean preoperative, 3 month, 1, 2, 3, 4, and 5 year scores. The SF-36 Health Survey is a 36 item patient-completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.

Outcome measures

Outcome measures
Measure	Trident® Tritanium™ Acetabular Shell n=184 hips Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
Change in SF-36 From Pre-operative to Post-operative Visits Physical score preoperative	33.26 units on a scale Standard Deviation 10.36
Change in SF-36 From Pre-operative to Post-operative Visits Physical score 3 months	38.9 units on a scale Standard Deviation 10.7
Change in SF-36 From Pre-operative to Post-operative Visits Physical score 1 year	43.04 units on a scale Standard Deviation 10.31
Change in SF-36 From Pre-operative to Post-operative Visits Physical score 2 years	43.55 units on a scale Standard Deviation 10.7
Change in SF-36 From Pre-operative to Post-operative Visits Physical score 3 years	43.54 units on a scale Standard Deviation 10.29
Change in SF-36 From Pre-operative to Post-operative Visits Physical score 4 years	42.76 units on a scale Standard Deviation 11.27
Change in SF-36 From Pre-operative to Post-operative Visits Physical score 5 years	43.82 units on a scale Standard Deviation 11.4
Change in SF-36 From Pre-operative to Post-operative Visits Mental score preoperative	49.56 units on a scale Standard Deviation 13.08
Change in SF-36 From Pre-operative to Post-operative Visits Mental score 3 months	52.07 units on a scale Standard Deviation 11.4
Change in SF-36 From Pre-operative to Post-operative Visits Mental score 1 year	52.81 units on a scale Standard Deviation 10.44
Change in SF-36 From Pre-operative to Post-operative Visits Mental score 2 years	53.37 units on a scale Standard Deviation 10.22
Change in SF-36 From Pre-operative to Post-operative Visits Mental score 3 years	53.84 units on a scale Standard Deviation 9.67
Change in SF-36 From Pre-operative to Post-operative Visits Mental score 4 years	53.63 units on a scale Standard Deviation 10.29
Change in SF-36 From Pre-operative to Post-operative Visits Mental score 5 years	52.93 units on a scale Standard Deviation 9.25

SECONDARY outcome

Timeframe: 3 month, 1, 2, 3, 4, 5 years

Population: Participants/hips are based on evaluable films for this data point. Overall number of participants and hips analyzed is based upon the 3 month population.

Defined as a lucent area seen parallel and in close proximity to the device at the prosthesis/bone interface encompassing at least 50% of the zone, and at least 1 mm or greater in width. May be accompanied by a radiopaque (reactive) line. Assessed for each of the three modified DeLee Charnley zones.

Outcome measures

Outcome measures
Measure	Trident® Tritanium™ Acetabular Shell n=154 hips Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones RLL> 2mm in all zones at 3 months	3 hips
Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones RLL> 2mm in all zones at 1 year	0 hips
Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones RLL> 2mm in all zones at 2 years	0 hips
Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones RLL> 2mm in all zones at 3 years	0 hips
Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones RLL> 2mm in all zones at 4 years	0 hips
Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones RLL> 2mm in all zones at 5 years	0 hips

SECONDARY outcome

Timeframe: 3 month, 1, 2, 3, 4, 5 years

Population: Participants/hips are based on evaluable films for this data point. Overall number of participants and hips is based upon the 3 month population.

Defined as the measurable change in the acetabular shell position relative to reproducible bony landmarks.

Outcome measures

Outcome measures
Measure	Trident® Tritanium™ Acetabular Shell n=158 hips Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction Migration >5mm at 3 months	0 hips
Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction Migration >5mm at 1 year	0 hips
Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction Migration >5mm at 2 years	0 hips
Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction Migration >5mm at 3 years	0 hips
Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction Migration >5mm at 4 years	0 hips
Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction Migration >5mm at 5 years	0 hips

SECONDARY outcome

Timeframe: pre-op, 3 month, 1, 2, 3, 4, 5 years

Population: Participants/hips with available data. Overall number of participants and hips analysed is based upon the preoperative population.

The change in LEAS is reported by comparing the mean pre-operative, 3 month, 1, 2, 3, 4, and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.

Outcome measures

Outcome measures
Measure	Trident® Tritanium™ Acetabular Shell n=189 hips Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative LEAS preoperative	8.32 units on a scale Standard Deviation 3.27
Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative LEAS 3 month	9.25 units on a scale Standard Deviation 2.74
Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative LEAS 1 year	10.5 units on a scale Standard Deviation 2.95
Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative LEAS 2 years	10.37 units on a scale Standard Deviation 3.25
Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative LEAS 3 years	10.6 units on a scale Standard Deviation 3.26
Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative LEAS 5 years	10.15 units on a scale Standard Deviation 3.16
Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative LEAS 4 years	10.25 units on a scale Standard Deviation 3.18

Adverse Events

Operative Site Events

Serious events: 28 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-operative Site Events

Serious events: 41 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Director, Clinical Operations

Stryker Orthopedics

Phone: 201-831-5401

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Each investigator shall have privileges for their own center's results at the completion of the study.These manuscripts \& abstracts will be delayed until after the multi-center publication is submitted.All publications shall be submitted to the sponsor for review at least 60 days prior to the submission for publication.The sponsor shall not edit or otherwise influence the publications other than to ensure that confidential information is not disclosed and that the data is accurately represented.
Publication restrictions are in place

Restriction type: OTHER

Measure	Operative Site Events n=193 participants at risk Trident® Tritanium™ Acetabular Shell used in revision total hip replacement. Operative site events are reported by hip.	Non-operative Site Events n=190 participants at risk Trident® Tritanium™ Acetabular Shell used in revision total hip replacement. Non-Operative site events are reported by participant.
Cardiac disorders Non-operative site	— 0/0 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.	5.3% 10/190 • Number of events 11 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.
Gastrointestinal disorders Non-operative site	— 0/0 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.	1.1% 2/190 • Number of events 3 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.
General disorders Non-operative site	— 0/0 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.	3.2% 6/190 • Number of events 6 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.
Hepatobiliary disorders Non-operative site	— 0/0 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.	0.53% 1/190 • Number of events 1 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.
Infections and infestations Operative site	4.7% 9/193 • Number of events 10 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.	— 0/0 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.
Infections and infestations Non-operative site	— 0/0 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.	4.7% 9/190 • Number of events 9 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.
Metabolism and nutrition disorders Non-operative site	— 0/0 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.	1.1% 2/190 • Number of events 2 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.
Musculoskeletal and connective tissue disorders Operative site	9.3% 18/193 • Number of events 19 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.	— 0/0 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.
Musculoskeletal and connective tissue disorders Non-operative site	— 0/0 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.	5.3% 10/190 • Number of events 10 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-operative site	— 0/0 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.	2.6% 5/190 • Number of events 7 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.
Nervous system disorders Non-operative site	— 0/0 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.	0.53% 1/190 • Number of events 1 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.
Renal and urinary disorders Non-operative site	— 0/0 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.	1.1% 2/190 • Number of events 2 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.
Respiratory, thoracic and mediastinal disorders Non-operative site	— 0/0 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.	1.1% 2/190 • Number of events 2 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.
Vascular disorders Non-operative site	— 0/0 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.	2.6% 5/190 • Number of events 5 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.
Vascular disorders Operative site	0.52% 1/193 • Number of events 1 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.	— 0/0 • Reportable adverse events for this study include those that are serious or related to the device. Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular \& bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, \& mid-foot/flat-foot surgery.