Trial Outcomes & Findings for Safety and Performance of PEEK Anchors in Extremities (NCT NCT03782298)

Last Updated: 2024-10-01

Results Overview

Clinical success was defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria: * no inflammatory or allergic response * no device-related adverse event (AE) * no device deficiencies (DDs) leading to revision surgery (re intervention) on the index extremity

Recruitment status

COMPLETED

Target enrollment

140 participants

Primary outcome timeframe

6 months

Results posted on

2024-10-01

Participant Flow

It was intended to enroll participants for 4 PEEK suture anchor devices; however, no participants were enrolled in the SPYROMITE™ 2.0 PK Suture Anchor with Needles group, resulting in 3 suture anchor groups being analyzed. A total of 140 participants were enrolled in the study and 142 joints were observed. Multiple devices were implanted in 2 participants. Separate "arms" not created as participants had the same procedure on the same joint. Anchors are shown by categories (rows) throughout.

Unit of analysis: joints

Participant milestones

Participant milestones
Measure	Polyetheretherketone (PEEK) Extremity Suture Anchors Participants who have received Polyetheretherketone (PEEK) Extremity Suture Anchors, which included: DYNOMITE™ 2.0 PK Suture Anchor with Needles, RAPTORMITE™ 3.0 Suture Anchor with Needles, FOOTPRINT™ Ultra PK SL Suture Anchor
Overall Study STARTED	140 142
Overall Study DYNOMITE™ 2.0 PK Suture Anchor With Needles	17 17
Overall Study RAPTORMITE™ 3.0 Suture Anchor With Needles	71 71
Overall Study FOOTPRINT™ Ultra PK SL Suture Anchor	57 59
Overall Study COMPLETED	136 136
Overall Study NOT COMPLETED	4 6

Reasons for withdrawal

Reasons for withdrawal
Measure	Polyetheretherketone (PEEK) Extremity Suture Anchors Participants who have received Polyetheretherketone (PEEK) Extremity Suture Anchors, which included: DYNOMITE™ 2.0 PK Suture Anchor with Needles, RAPTORMITE™ 3.0 Suture Anchor with Needles, FOOTPRINT™ Ultra PK SL Suture Anchor
Overall Study Protocol Deviation	4

Baseline Characteristics

Data only available for 102 participants due to the retrospective nature of the study.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Polyetheretherketone (PEEK) Extremity Suture Anchors n=142 joints Participants who have received Polyetheretherketone (PEEK) Extremity Suture Anchors, which included: DYNOMITE™ 2.0 PK Suture Anchor with Needles, RAPTORMITE™ 3.0 Suture Anchor with Needles, FOOTPRINT™ Ultra PK SL Suture Anchor
Age, Continuous	45 years STANDARD_DEVIATION 13.6 • n=142 joints
Sex: Female, Male Female	83 joints n=142 joints
Sex: Female, Male Male	59 joints n=142 joints
Ethnicity (NIH/OMB) Hispanic or Latino	6 joints n=142 joints
Ethnicity (NIH/OMB) Not Hispanic or Latino	115 joints n=142 joints
Ethnicity (NIH/OMB) Unknown or Not Reported	21 joints n=142 joints
Race/Ethnicity, Customized American Indian or Alaska Native · No	142 joints n=142 joints
Race/Ethnicity, Customized American Indian or Alaska Native · Yes	0 joints n=142 joints
Race/Ethnicity, Customized Asian · No	142 joints n=142 joints
Race/Ethnicity, Customized Asian · Yes	0 joints n=142 joints
Race/Ethnicity, Customized Black or African American · No	137 joints n=142 joints
Race/Ethnicity, Customized Black or African American · Yes	5 joints n=142 joints
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander · No	142 joints n=142 joints
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander · Yes	0 joints n=142 joints
Race/Ethnicity, Customized White · No	22 joints n=142 joints
Race/Ethnicity, Customized White · Yes	120 joints n=142 joints
Race/Ethnicity, Customized Other · No	124 joints n=142 joints
Race/Ethnicity, Customized Other · Yes	18 joints n=142 joints
Location of Device Implantation Left	72 joints n=142 joints
Location of Device Implantation Right	66 joints n=142 joints
Location of Device Implantation Bilaterally	4 joints n=142 joints
Duration of Surgery (min)	67 minutes STANDARD_DEVIATION 28.5 • n=102 Participants • Data only available for 102 participants due to the retrospective nature of the study.
Duration of time from injury to surgery (days)	508.4 days STANDARD_DEVIATION 994.7 • n=87 Participants • Data only available for 87 participants due to the retrospective nature of the study.
Number of Joints Treated by Indication Medial instability	58 joints n=142 joints
Number of Joints Treated by Indication Achilles tendon	54 joints n=142 joints
Number of Joints Treated by Indication Midfoot	2 joints n=142 joints
Number of Joints Treated by Indication Metatarsal ligament	11 joints n=142 joints
Number of Joints Treated by Indication Other	6 joints n=142 joints
Number of Joints Treated by Indication Medial instability & Achilles tendon	1 joints n=142 joints
Number of Joints Treated by Indication Medial instability & Other	5 joints n=142 joints
Number of Joints Treated by Indication Midfoot & Metatarsal ligament	4 joints n=142 joints
Number of Joints Treated by Indication Metatarsal ligament & Other	1 joints n=142 joints
Disposition of Suture Anchors DYNOMITE™ 2.0 PK Suture Anchor with Needles	17 Participants n=140 Participants • Information provided based on the unique device implanted. Out of 140 overall participants, 2 were implanted with multiple Suture Anchors (devices).
Disposition of Suture Anchors RAPTORMITE™ 3.0 PK Suture Anchor with Needles	71 Participants n=140 Participants • Information provided based on the unique device implanted. Out of 140 overall participants, 2 were implanted with multiple Suture Anchors (devices).
Disposition of Suture Anchors FOOTPRINT™ Ultra PK SL Suture Anchor	57 Participants n=140 Participants • Information provided based on the unique device implanted. Out of 140 overall participants, 2 were implanted with multiple Suture Anchors (devices).

PRIMARY outcome

Timeframe: 6 months

Population: Participants analyzed at time frame specified for each row indicates participant provided retrospective data. Some participants implanted with multiple Suture Anchors (devices). Data analyzed independently based on specific device implanted (i.e., participants with multiple devices analyzed by unique suture anchor). Anchors shown by rows/categories as the same procedure occurred on the same joint. Overall number of participants analyzed shows combined total of distinct participants assessed.

Outcome measures

Outcome measures
Measure	Polyetheretherketone (PEEK) Extremity Suture Anchors n=140 Participants Participants who have received Polyetheretherketone (PEEK) Extremity Suture Anchors, which included: DYNOMITE™ 2.0 PK Suture Anchor with Needles, RAPTORMITE™ 3.0 Suture Anchor with Needles, FOOTPRINT™ Ultra PK SL Suture Anchor
Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 6 Months After Intervention DYNOMITE™ 2.0 PK Suture Anchor with Needles · Yes	16 Participants
Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 6 Months After Intervention DYNOMITE™ 2.0 PK Suture Anchor with Needles · No	1 Participants
Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 6 Months After Intervention RAPTORMITE™ 3.0 PK Suture Anchor with Needles · Yes	70 Participants
Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 6 Months After Intervention RAPTORMITE™ 3.0 PK Suture Anchor with Needles · No	1 Participants
Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 6 Months After Intervention FOOTPRINT™ ULTRA PK SL SUTURE ANCHOR · Yes	57 Participants
Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 6 Months After Intervention FOOTPRINT™ ULTRA PK SL SUTURE ANCHOR · No	0 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Polyetheretherketone (PEEK) Extremity Suture Anchors n=23 Participants Participants who have received Polyetheretherketone (PEEK) Extremity Suture Anchors, which included: DYNOMITE™ 2.0 PK Suture Anchor with Needles, RAPTORMITE™ 3.0 Suture Anchor with Needles, FOOTPRINT™ Ultra PK SL Suture Anchor
Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 12 Months After Intervention DYNOMITE™ 2.0 PK Suture Anchor With Needles · Yes	2 Participants
Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 12 Months After Intervention DYNOMITE™ 2.0 PK Suture Anchor With Needles · No	0 Participants
Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 12 Months After Intervention RAPTORMITE™ 3.0 Suture Anchor With Needles · Yes	8 Participants
Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 12 Months After Intervention RAPTORMITE™ 3.0 Suture Anchor With Needles · No	0 Participants
Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 12 Months After Intervention FOOTPRINT™ Ultra PK SL Suture Anchor · Yes	16 Participants
Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 12 Months After Intervention FOOTPRINT™ Ultra PK SL Suture Anchor · No	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 and 12 months

The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain and a score of 10 indicates extreme/unbearable pain. The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery.

Outcome measures

Outcome measures
Measure	Polyetheretherketone (PEEK) Extremity Suture Anchors n=48 Participants Participants who have received Polyetheretherketone (PEEK) Extremity Suture Anchors, which included: DYNOMITE™ 2.0 PK Suture Anchor with Needles, RAPTORMITE™ 3.0 Suture Anchor with Needles, FOOTPRINT™ Ultra PK SL Suture Anchor
Visual Analog Scale (VAS) - Pain DYNOMITE™ 2.0 PK Suture Anchor With Needles: 6 months	2 score on a scale Standard Deviation NA Standard deviation not calculated whenever there was only 1 participant's data available
Visual Analog Scale (VAS) - Pain RAPTORMITE™ 3.0 Suture Anchor With Needles: 6 months	1.8 score on a scale Standard Deviation 2.2
Visual Analog Scale (VAS) - Pain RAPTORMITE™ 3.0 Suture Anchor With Needles: 12 months	3.7 score on a scale Standard Deviation 4.0
Visual Analog Scale (VAS) - Pain FOOTPRINT™ Ultra PK SL Suture Anchor: 6 months	2.6 score on a scale Standard Deviation 2.5
Visual Analog Scale (VAS) - Pain FOOTPRINT™ Ultra PK SL Suture Anchor: 12 months	2 score on a scale Standard Deviation 2.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 and 12 months

Range of motion defined as the participant having a full functional arc "Yes" or "No" at 6 month and 12 month post-operative visits.

Outcome measures

Outcome measures
Measure	Polyetheretherketone (PEEK) Extremity Suture Anchors n=98 Participants Participants who have received Polyetheretherketone (PEEK) Extremity Suture Anchors, which included: DYNOMITE™ 2.0 PK Suture Anchor with Needles, RAPTORMITE™ 3.0 Suture Anchor with Needles, FOOTPRINT™ Ultra PK SL Suture Anchor
Count of Participants With Range of Motion (ROM) Full Functional Arc FOOTPRINT™ Ultra PK SL Suture Anchor: 12 months · Has full functional arc: No	1 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc FOOTPRINT™ Ultra PK SL Suture Anchor: 12 months · Has full functional arc: Unknown	0 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc DYNOMITE™ 2.0 PK Suture Anchor With Needles: 6 months · Has full functional arc: Yes	3 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc DYNOMITE™ 2.0 PK Suture Anchor With Needles: 6 months · Has full functional arc: No	2 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc DYNOMITE™ 2.0 PK Suture Anchor With Needles: 6 months · Has full functional arc: Unknown	1 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc RAPTORMITE™ 3.0 Suture Anchor With Needles: 6 months · Has full functional arc: Yes	21 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc RAPTORMITE™ 3.0 Suture Anchor With Needles: 6 months · Has full functional arc: No	5 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc RAPTORMITE™ 3.0 Suture Anchor With Needles: 6 months · Has full functional arc: Unknown	29 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc RAPTORMITE™ 3.0 Suture Anchor With Needles: 12 months · Has full functional arc: Yes	1 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc RAPTORMITE™ 3.0 Suture Anchor With Needles: 12 months · Has full functional arc: No	2 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc RAPTORMITE™ 3.0 Suture Anchor With Needles: 12 months · Has full functional arc: Unknown	3 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc FOOTPRINT™ Ultra PK SL Suture Anchor: 6 months · Has full functional arc: Yes	34 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc FOOTPRINT™ Ultra PK SL Suture Anchor: 6 months · Has full functional arc: No	8 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc FOOTPRINT™ Ultra PK SL Suture Anchor: 6 months · Has full functional arc: Unknown	0 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc FOOTPRINT™ Ultra PK SL Suture Anchor: 12 months · Has full functional arc: Yes	11 Participants

Adverse Events

DYNOMITE™ 2.0 PK Suture Anchor With Needles

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

RAPTORMITE™ 3.0 Suture Anchor With Needles

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

FOOTPRINT™ Ultra PK SL Suture Anchor

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DYNOMITE™ 2.0 PK Suture Anchor With Needles n=17 participants at risk Participants who have received DYNOMITE™ 2.0 PK Suture Anchor with Needles	RAPTORMITE™ 3.0 Suture Anchor With Needles n=71 participants at risk Participants who have received RAPTORMITE™ 3.0 Suture Anchor with Needles	FOOTPRINT™ Ultra PK SL Suture Anchor n=57 participants at risk Participants who have received FOOTPRINT™ Ultra PK SL Suture Anchor
Musculoskeletal and connective tissue disorders SURAL NERVE DAMAGE AND MONONEUROPATHY/PAIN SYNDROME FROM POPLITEAL ANESTHETIC BLOCK.	0.00% 0/17 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	0.00% 0/71 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	1.8% 1/57 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
Infections and infestations HOSPITALIZATION FOR UTI, ACUTE RENAL FAILURE, SEPSIS	0.00% 0/17 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	1.4% 1/71 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	1.8% 1/57 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
General disorders COMPLEX REGIONAL PAIN SYNDROME	0.00% 0/17 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	1.4% 1/71 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	0.00% 0/57 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).

Other adverse events

Other adverse events
Measure	DYNOMITE™ 2.0 PK Suture Anchor With Needles n=17 participants at risk Participants who have received DYNOMITE™ 2.0 PK Suture Anchor with Needles	RAPTORMITE™ 3.0 Suture Anchor With Needles n=71 participants at risk Participants who have received RAPTORMITE™ 3.0 Suture Anchor with Needles	FOOTPRINT™ Ultra PK SL Suture Anchor n=57 participants at risk Participants who have received FOOTPRINT™ Ultra PK SL Suture Anchor
General disorders LEFT ACHILLES CHRONIC PAIN	0.00% 0/17 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	0.00% 0/71 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	1.8% 1/57 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
Skin and subcutaneous tissue disorders DEHISCENCE WOUND	0.00% 0/17 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	0.00% 0/71 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	1.8% 1/57 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
General disorders PAIN OVER LATERAL ASPECT OF LEFT ANKLE (ONGOING AT 6 MONTHS).	5.9% 1/17 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	0.00% 0/71 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	0.00% 0/57 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
General disorders PAIN OVER LATERAL ASPECT OF LEFT ANKLE AT 6 MONTHS	5.9% 1/17 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	0.00% 0/71 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	0.00% 0/57 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
Infections and infestations SUPERFICIAL YEAST INFECTION	5.9% 1/17 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	0.00% 0/71 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	0.00% 0/57 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
Vascular disorders DEEP VEIN THROMBOSIS	5.9% 1/17 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	0.00% 0/71 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	0.00% 0/57 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
Injury, poisoning and procedural complications FALL DOWN ON LEFT HEEL	5.9% 1/17 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	0.00% 0/71 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	0.00% 0/57 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).

Additional Information

Judith Horner

Smtih + Nephew, Inc

Phone: +44 1482 673251

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60