Trial Outcomes & Findings for A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears (NCT NCT02493660)

Last Updated: 2022-06-15

Results Overview

The primary composite effectiveness endpoint was defined as achievement of improvement for the Western Ontario Rotator Cuff (WORC) score (≥275 points) and American Shoulder and Elbow Society (ASES) score (≥6.4 points) by week 6 and maintenance at month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs). The improvement of points of the Western Ontario Rotator Cuff (WORC) of at least 275 (point scale of 0-2100:lower score is better) and American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful.

Recruitment status

COMPLETED

Study phase

Target enrollment

184 participants

Primary outcome timeframe

Baseline to month 12

Results posted on

2022-06-15

Participant Flow

Subjects assessed for eligibility n=229

Subjects excluded (n=45) for various reasons, not meeting criteria (n=11), declined to participate (n=12), and Other (n=22) such as, no medical clearance for surgery, intra-op screen failures, enrollment full.

Participant milestones

Participant milestones
Measure	InSpace Implantation Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system	Tendon Repair Arthroscopic partial repair of rotator cuff Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
Overall Study STARTED	93	91
Overall Study COMPLETED	83	79
Overall Study NOT COMPLETED	10	12

Reasons for withdrawal

Reasons for withdrawal
Measure	InSpace Implantation Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system	Tendon Repair Arthroscopic partial repair of rotator cuff Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
Overall Study Physician Decision	0	1
Overall Study Adverse Event	4	2
Overall Study Withdrawal by Subject	2	3
Overall Study Subject unable to return for follow-up visits	2	0
Overall Study Protocol Violation	0	1
Overall Study Death	0	1
Overall Study Lost to Follow-up	2	4

Baseline Characteristics

A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	InSpace Implantation n=93 Participants Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system	Tendon Repair n=91 Participants Arthroscopic partial repair of rotator cuff Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff	Total n=184 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants	44 Participants n=7 Participants	82 Participants n=5 Participants
Age, Categorical >=65 years	55 Participants n=5 Participants	47 Participants n=7 Participants	102 Participants n=5 Participants
Age, Continuous	66.8 Years STANDARD_DEVIATION 7.70 • n=5 Participants	64.7 Years STANDARD_DEVIATION 7.88 • n=7 Participants	65.8 Years STANDARD_DEVIATION 7.84 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	41 Participants n=7 Participants	84 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	91 Participants n=5 Participants	89 Participants n=7 Participants	180 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	83 Participants n=5 Participants	80 Participants n=7 Participants	163 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	3 Participants n=7 Participants	5 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 Canada	15 participants n=5 Participants	12 participants n=7 Participants	27 participants n=5 Participants
Region of Enrollment United States	78 participants n=5 Participants	78 participants n=7 Participants	156 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to month 12

Population: Percentage of participants in the Per Protocol Population (PP) with surgical treatment success of the InSpace device as a Primary surgical treatment for Full-thickness massive rotator cuff tears (MRCT).

Outcome measures

Outcome measures
Measure	InSpace Implantation n=88 Participants InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system	Tendon Repair n=88 Participants Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
Percentage of Participants in the Per Protocol Population With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears From Baseline to Month 12 With no SSSIs and no SADEs.	51.1 percentage of participants	39.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline through to Month 24

Population: Per Protocol Population with no major protocol deviations.

Composite Endpoint Per Protocol Population (PP) of WORC Improvement ≥ 275 and ASES Improvement ≥ 6.4 from baseline at Week 6 Maintained at Month 24 with no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (pre-specified).

Outcome measures

Outcome measures
Measure	InSpace Implantation n=82 Participants InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system	Tendon Repair n=79 Participants Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
Composite Endpoint of WORC Improvement ≥275 and ASES Improvement ≥6.4 at Week 6 Maintained at Month 24 no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (Pre-specified). Composite WORC ASES and Safety to M24	46.3 percentage of participants Interval 35.5 to 57.1	38.0 percentage of participants Interval 27.0 to 49.0

SECONDARY outcome

Timeframe: Baseline to month 12

Population: Per Protocol Population

The secondary effectiveness endpoint was defined as a composite component-level success at Month 12 for Western Ontario Rotator Cuff (WORC) total score improvement (≥275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs).

Outcome measures

Outcome measures
Measure	InSpace Implantation n=88 Participants InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system	Tendon Repair n=88 Participants Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
Composite Endpoint Component Level Success for WORC at Month 12 Compared to Baseline in the Per Protocol Population (PP)	89.8 percentage of participants	87.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline to month 12

Population: Per Protocol Population

The secondary endpoint was defined as a composite component-level success for American Shoulder and Elbow Surgeons ( ASES) compared at baseline to Month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs).. The total score improvement of (≥ 6.4 points) (scale of 0-100:higher score is better) from baseline in the two groups, InSpace and Partial Repair.

Outcome measures

Outcome measures
Measure	InSpace Implantation n=88 Participants InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system	Tendon Repair n=88 Participants Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
Composite Endpoint Component Level Success for ASES at Month 12 Compared to Baseline in the Per Protocol Population (PP)	96.3 percentage of participants	90.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline through to month 24

Population: The Intent To Treat (ITT) population with available data.

The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Western Ontario Rotator Cuff (WORC) total score improvement (≥275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair.

Outcome measures

Outcome measures
Measure	InSpace Implantation n=83 Participants InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system	Tendon Repair n=78 Participants Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. WORC	-1083.37 score on a scale Interval -1199.94 to -966.81	-1007.00 score on a scale Interval -1108.34 to -905.67

SECONDARY outcome

Timeframe: Baseline through to month 24

Population: Intent To Treat (ITT) Population with available data

Mean change in American Shoulder and Elbow Surgeons (ASES) score from baseline to month 24. The improvement of points of the American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful.

Outcome measures

Outcome measures
Measure	InSpace Implantation n=83 Participants InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system	Tendon Repair n=79 Participants Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. ASES	46.22 score on a scale Interval 41.66 to 50.79	42.53 score on a scale Interval 37.96 to 47.1

SECONDARY outcome

Timeframe: Baseline to month 24

Population: Intent to Treat (ITT) Population with available data

The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Constant-Murley (CS) Shoulder Outcome score (where the scale of 0-100:higher score is better) in the two groups, InSpace and Partial Repair.

Outcome measures

Outcome measures
Measure	InSpace Implantation n=83 Participants InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system	Tendon Repair n=79 Participants Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
Mean Change From Baseline to Month 24 for Constant-Murley (CS) in the Intent To Treat Population (ITT) With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears	28.22 score on a scale Interval 23.92 to 32.51	21.81 score on a scale Interval 16.99 to 26.63

SECONDARY outcome

Timeframe: Baseline through to month 24

Population: Intent to Treat (ITT) Population with available data

The secondary effectiveness endpoint was defined as change in baseline to Month 24 for Quality of Life (EQ-5D-5L) (scale of 0-100: lower score better) in the two groups, InSpace and Partial Repair.

Outcome measures

Outcome measures
Measure	InSpace Implantation n=83 Participants InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system	Tendon Repair n=78 Participants Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
The Mean Change From Baseline to Month 24 for EQ-5D-5L for Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears	-4.65 score on a scale Interval -5.36 to -3.94	-4.00 score on a scale Interval -4.61 to -3.39

SECONDARY outcome

Timeframe: Baseline through to month 24

Population: Intent To Treat (ITT) Population with available data

The secondary effectiveness endpoint was defined as the mean change from baseline at Month 24 for Visual Analogue Scale (VAS) (scale of 0-100:lower score is better) in the two groups, InSpace and Partial Repair.

Outcome measures

Outcome measures
Measure	InSpace Implantation n=83 Participants InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system	Tendon Repair n=78 Participants Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
Mean Change From Baseline to Month 24 for VAS in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears	-56.55 score on a scale Interval -61.78 to -51.32	-54.55 score on a scale Interval -59.92 to -49.19

SECONDARY outcome

Timeframe: Baseline through to month 24

Population: Intent to Treat (ITT) Population with available data

The secondary effectiveness endpoint was defined as mean change from baseline at Month 24 for American Shoulder and Elbow Surgeons (ASES) range of motion (ROM)-physician reported portion. (scale of 0-180 Degrees: higher score is better) in the two groups, InSpace and Partial Repair.

Outcome measures

Outcome measures
Measure	InSpace Implantation n=82 Participants InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system	Tendon Repair n=77 Participants Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
Mean Change From Baseline to Month 24 for ASES ROM in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears	36.89 score on a scale Interval 28.02 to 45.76	18.16 score on a scale Interval 9.33 to 26.98

Adverse Events

InSpace Implantation

Serious events: 22 serious events

Other events: 67 other events

Deaths: 0 deaths

Tendon Repair

Serious events: 22 serious events

Other events: 69 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	InSpace Implantation n=93 participants at risk Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system	Tendon Repair n=91 participants at risk Arthroscopic partial repair of rotator cuff Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
Musculoskeletal and connective tissue disorders eg. Pain or inflammation	10.8% 10/93 • Number of events 11 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.	12.1% 11/91 • Number of events 12 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
Nervous system disorders eg. dizziness, Aphasia, Cerebrovascular accident	4.3% 4/93 • Number of events 6 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.	2.2% 2/91 • Number of events 3 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) eg.Prostate cancer, leukemia, Parathyroid tumor	3.2% 3/93 • Number of events 4 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.	4.4% 4/91 • Number of events 4 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
Cardiac disorders eg. Multi-vessel Coronary Artery Disease	1.1% 1/93 • Number of events 1 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.	0.00% 0/91 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
Respiratory, thoracic and mediastinal disorders eg.Laryngeal granuloma, Chronic obstructive pulmonary disease, pulmonary mass	3.2% 3/93 • Number of events 3 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.	1.1% 1/91 • Number of events 1 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
Gastrointestinal disorders eg. Gastrointestinal haemorrhage, short-bowel syndrome, small intestinal obstruction	2.2% 2/93 • Number of events 4 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.	0.00% 0/91 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
General disorders eg. Event leading to Death, non-cardiac chest pain, surgical failure	0.00% 0/93 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.	3.3% 3/91 • Number of events 3 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
Cardiac disorders Angina Pectoris (Chest pain-Cardiac)	0.00% 0/93 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.	1.1% 1/91 • Number of events 1 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
Cardiac disorders Atrial Fibrillation	1.1% 1/93 • Number of events 1 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.	0.00% 0/91 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
Cardiac disorders Cardiac Arrest	1.1% 1/93 • Number of events 1 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.	0.00% 0/91 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.

Other adverse events

Other adverse events
Measure	InSpace Implantation n=93 participants at risk Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system	Tendon Repair n=91 participants at risk Arthroscopic partial repair of rotator cuff Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
Musculoskeletal and connective tissue disorders Musculoskeletal pain, Arthralgia, back pain (anywhere in body)	54.8% 51/93 • Number of events 96 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.	52.7% 48/91 • Number of events 71 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
Injury, poisoning and procedural complications Fall and injury, meniscus injury, Tendon rupture (anywhere in body)	14.0% 13/93 • Number of events 18 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.	24.2% 22/91 • Number of events 23 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
Infections and infestations UTI, Bronchitis, pneumonia	17.2% 16/93 • Number of events 23 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.	12.1% 11/91 • Number of events 13 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
Nervous system disorders Headache, dizziness	10.8% 10/93 • Number of events 14 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.	11.0% 10/91 • Number of events 12 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
General disorders Pain, Local swelling	10.8% 10/93 • Number of events 12 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.	5.5% 5/91 • Number of events 5 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
Gastrointestinal disorders Constipation	6.5% 6/93 • Number of events 10 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.	6.6% 6/91 • Number of events 6 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	7.5% 7/93 • Number of events 8 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.	4.4% 4/91 • Number of events 4 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
Cardiac disorders Atrial fibrillation	2.2% 2/93 • Number of events 2 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.	1.1% 1/91 • Number of events 1 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
Cardiac disorders Tachycardia	2.2% 2/93 • Number of events 2 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.	0.00% 0/91 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
Cardiac disorders Pre-Ventricular Contractions	1.1% 1/93 • Number of events 1 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.	0.00% 0/91 • Collected over 12 months and 24 months visit. The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.

Additional Information

Colleen Roden, Director, Clinical Operations

Stryker Company

Phone: 1 931 267 2041

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 45 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and can only extend the embargo with patent protection review.
Publication restrictions are in place

Restriction type: OTHER