Soft Tissue to Bone Fixation
Conditions
Brief summary
Post-market clinical follow-up on the PEEK Suture Anchors in the shoulder.
Interventions
DEVICEPolyetheretherketone (PEEK) Shoulder Suture Anchors
PEEK Suture Anchors, which include: * HEALICOIL™ PK Preloaded Suture Anchors * BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors * BIORAPTOR™ Knotless Suture Anchors * MULTIFIX™ S Ultra Knotless Fixation System * FOOTPRINT™ Ultra PK Suture Anchors * TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles * SPEEDSCREW™ Knotless Fixation System * SpeedLock Knotless Fixation Device
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects who have undergone shoulder joint repair using the study devices. 2. Subjects aged 18 years and older at the time of surgery.
Exclusion criteria
1. Subjects who are \< 12 months post-operative. 2. Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 30 days prior to surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention | 6 months | Clinical success was defined as shoulder 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 shoulder |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention | 12 months | Clinical success was defined as shoulder 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 shoulder |
| Visual Analog Scale (VAS) - Pain | 6 and 12 months | The VAS is a continuous scale comprised of a horizontal line 100 millimeters (mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain (0 mm) and a score of 10 indicates extreme/unbearable pain (100 mm). The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery. |
| Count of Participants With Range of Motion (ROM) Full Functional Arc | 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. |
| Range of Motion (ROM) | 6 and 12 months | Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on physician's Standard of Care. |
Countries
United States
Participant flow
Pre-assignment details
It was intended to enroll participants for 8 PEEK suture anchor devices; however, no participants were enrolled for the BIORAPTOR™ Knotless Suture Anchors, resulting in 7 suture anchor groups being analyzed. A total of 464 participants were enrolled in the study and 467 joints were observed. Multiple devices were implanted in 124 participants.
Participants by arm
| Arm | Count |
|---|---|
| Polyetheretherketone (PEEK) Shoulder Suture Anchors Participants who have received PEEK Suture Anchors in the shoulder which included:
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device | 464 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors Participants who have received PEEK Suture Anchors in the shoulder which included:
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device | 467 |
| Total | 931 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol deviation | 21 |
Baseline characteristics
| Characteristic | Polyetheretherketone (PEEK) Shoulder Suture Anchors |
|---|---|
| Age, Continuous | 54.00 years STANDARD_DEVIATION 14.1 |
| Any Medical History No | 75 joints |
| Any Medical History Yes | 392 joints |
| Disposition of Suture Anchors BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor | 41 Participants |
| Disposition of Suture Anchors FOOTPRINT™ Ultra PK Suture Anchor | 136 Participants |
| Disposition of Suture Anchors HEALICOIL™ PK Preloaded Suture Anchors | 193 Participants |
| Disposition of Suture Anchors MULTIFIX™ S Ultra Knotless Fixation System | 78 Participants |
| Disposition of Suture Anchors SpeedLock Knotless Fixation Device | 18 Participants |
| Disposition of Suture Anchors SPEEDSCREW™ Knotless Fixation System | 59 Participants |
| Disposition of Suture Anchors TWINFIX™ Ultra PK Suture Anchor | 57 Participants |
| Duration of Surgery | 99.2 minutes STANDARD_DEVIATION 50.7 |
| Duration of time from injury to surgery | 405.7 days STANDARD_DEVIATION 929.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 joints |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 367 joints |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 70 joints |
| Location of Device Implantation Bilaterally | 2 joints |
| Location of Device Implantation Left Shoulder | 194 joints |
| Location of Device Implantation Right Shoulder | 271 joints |
| Number of Participant Joints Treated by Indication Bankart lesion repair | 12 joints |
| Number of Participant Joints Treated by Indication Biceps tenodesis | 33 joints |
| Number of Participant Joints Treated by Indication Capsular shift | 5 joints |
| Number of Participant Joints Treated by Indication Other | 2 joints |
| Number of Participant Joints Treated by Indication Rotator cuff repair | 413 joints |
| Number of Participant Joints Treated by Indication SLAP lesion repair | 2 joints |
| Race/Ethnicity, Customized American Indian or Alaska Native No | 462 joints |
| Race/Ethnicity, Customized American Indian or Alaska Native Yes | 5 joints |
| Race/Ethnicity, Customized Asian No | 464 joints |
| Race/Ethnicity, Customized Asian Yes | 3 joints |
| Race/Ethnicity, Customized Black or African American No | 444 joints |
| Race/Ethnicity, Customized Black or African American Yes | 23 joints |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander No | 465 joints |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander Yes | 2 joints |
| Race/Ethnicity, Customized Other No | 403 joints |
| Race/Ethnicity, Customized Other Yes | 64 joints |
| Race/Ethnicity, Customized White No | 94 joints |
| Race/Ethnicity, Customized White Yes | 373 joints |
| Region of Enrollment United States | 467 joints |
| Sex: Female, Male Female | 190 joints |
| Sex: Female, Male Male | 277 joints |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 193 | 0 / 41 | 0 / 78 | 0 / 136 | 0 / 57 | 0 / 59 | 0 / 18 |
| other Total, other adverse events | 40 / 193 | 27 / 41 | 38 / 78 | 24 / 136 | 5 / 57 | 4 / 59 | 0 / 18 |
| serious Total, serious adverse events | 15 / 193 | 7 / 41 | 13 / 78 | 10 / 136 | 1 / 57 | 4 / 59 | 0 / 18 |
Outcome results
Primary
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
Clinical success was defined as shoulder 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 shoulder
Time frame: 6 months
Population: Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention | HEALICOIL™ PK Preloaded Suture Anchors | Yes | 185 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention | HEALICOIL™ PK Preloaded Suture Anchors | No | 6 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention | BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor | Yes | 38 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention | BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor | No | 3 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention | MULTIFIX™ S Ultra Knotless Fixation System | Yes | 71 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention | MULTIFIX™ S Ultra Knotless Fixation System | No | 6 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention | FOOTPRINT™ Ultra PK Suture Anchor | Yes | 128 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention | FOOTPRINT™ Ultra PK Suture Anchor | No | 3 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention | TWINFIX™ Ultra PK Suture Anchor | Yes | 57 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention | TWINFIX™ Ultra PK Suture Anchor | No | 0 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention | SPEEDSCREW™ Knotless Fixation System | Yes | 58 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention | SPEEDSCREW™ Knotless Fixation System | No | 1 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention | SpeedLock Knotless Fixation Device | Yes | 18 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention | SpeedLock Knotless Fixation Device | No | 0 Participants |
Secondary
Count of Participants With Range of Motion (ROM) Full Functional Arc
Range of motion defined as the participant having a full functional arc Yes or No at 6 month and 12 month post-operative visits.
Time frame: 6 and 12 months
Population: Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | HEALICOIL™ PK Preloaded Suture Anchors: 6 months | Has full functional arc: Yes | 111 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | HEALICOIL™ PK Preloaded Suture Anchors: 6 months | Has full functional arc: No | 48 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | HEALICOIL™ PK Preloaded Suture Anchors: 6 months | Has full functional arc: Unknown | 4 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | HEALICOIL™ PK Preloaded Suture Anchors: 12 months | Has full functional arc: Yes | 37 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | HEALICOIL™ PK Preloaded Suture Anchors: 12 months | Has full functional arc: No | 10 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | HEALICOIL™ PK Preloaded Suture Anchors: 12 months | Has full functional arc: Unknown | 2 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 6 months | Has full functional arc: Yes | 29 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 6 months | Has full functional arc: No | 3 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 6 months | Has full functional arc: Unknown | 1 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 12 months | Has full functional arc: Yes | 1 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 12 months | Has full functional arc: No | 1 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 12 months | Has full functional arc: Unknown | 0 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | MULTIFIX™ S Ultra Knotless Fixation System: 6 months | Has full functional arc: Yes | 35 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | MULTIFIX™ S Ultra Knotless Fixation System: 6 months | Has full functional arc: No | 12 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | MULTIFIX™ S Ultra Knotless Fixation System: 6 months | Has full functional arc: Unknown | 4 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | MULTIFIX™ S Ultra Knotless Fixation System: 12 months | Has full functional arc: Yes | 9 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | MULTIFIX™ S Ultra Knotless Fixation System: 12 months | Has full functional arc: No | 7 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | MULTIFIX™ S Ultra Knotless Fixation System: 12 months | Has full functional arc: Unknown | 0 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | FOOTPRINT™ Ultra PK Suture Anchor: 6 months | Has full functional arc: Yes | 90 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | FOOTPRINT™ Ultra PK Suture Anchor: 6 months | Has full functional arc: No | 14 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | FOOTPRINT™ Ultra PK Suture Anchor: 6 months | Has full functional arc: Unknown | 1 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | FOOTPRINT™ Ultra PK Suture Anchor: 12 months | Has full functional arc: Yes | 17 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | FOOTPRINT™ Ultra PK Suture Anchor: 12 months | Has full functional arc: No | 2 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | FOOTPRINT™ Ultra PK Suture Anchor: 12 months | Has full functional arc: Unknown | 0 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | SPEEDSCREW™ Knotless Fixation System: 6 months | Has full functional arc: Yes | 46 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | SPEEDSCREW™ Knotless Fixation System: 6 months | Has full functional arc: No | 5 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | SPEEDSCREW™ Knotless Fixation System: 6 months | Has full functional arc: Unknown | 3 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | SPEEDSCREW™ Knotless Fixation System: 12 months | Has full functional arc: Yes | 4 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | SPEEDSCREW™ Knotless Fixation System: 12 months | Has full functional arc: No | 1 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | SPEEDSCREW™ Knotless Fixation System: 12 months | Has full functional arc: Unknown | 0 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | SpeedLock Knotless Fixation Device: 6 months | Has full functional arc: Yes | 18 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | SpeedLock Knotless Fixation Device: 6 months | Has full functional arc: No | 0 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | SpeedLock Knotless Fixation Device: 6 months | Has full functional arc: Unknown | 0 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | SpeedLock Knotless Fixation Device: 12 months | Has full functional arc: Yes | 2 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | SpeedLock Knotless Fixation Device: 12 months | Has full functional arc: No | 0 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | SpeedLock Knotless Fixation Device: 12 months | Has full functional arc: Unknown | 0 Participants |
Secondary
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention
Clinical success was defined as shoulder 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 shoulder
Time frame: 12 months
Population: Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention | HEALICOIL™ PK Preloaded Suture Anchors | Yes | 50 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention | HEALICOIL™ PK Preloaded Suture Anchors | No | 1 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention | BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor | Yes | 5 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention | BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor | No | 0 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention | MULTIFIX™ S Ultra Knotless Fixation System | Yes | 17 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention | MULTIFIX™ S Ultra Knotless Fixation System | No | 1 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention | FOOTPRINT™ Ultra PK Suture Anchor | Yes | 16 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention | FOOTPRINT™ Ultra PK Suture Anchor | No | 2 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention | TWINFIX™ Ultra PK Suture Anchor | Yes | 6 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention | TWINFIX™ Ultra PK Suture Anchor | No | 0 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention | SPEEDSCREW™ Knotless Fixation System | Yes | 4 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention | SPEEDSCREW™ Knotless Fixation System | No | 1 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention | SpeedLock Knotless Fixation Device | Yes | 2 Participants |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention | SpeedLock Knotless Fixation Device | No | 0 Participants |
Secondary
Range of Motion (ROM)
Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on physician's Standard of Care.
Time frame: 6 and 12 months
Population: Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: External Rotation (6 months) | 100 degrees | Standard Deviation 30 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | HEALICOIL™ PK Preloaded Suture Anchors: Forward Flexion Angle (6 months) | 157 degrees | Standard Deviation 20.2 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | HEALICOIL™ PK Preloaded Suture Anchors: Internal Rotation Angle (6 months) | 25.7 degrees | Standard Deviation 40.6 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | HEALICOIL™ PK Preloaded Suture Anchors: External Rotation (6 months) | 49.3 degrees | Standard Deviation 20.5 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | HEALICOIL™ PK Preloaded Suture Anchors Forward Flexion Angle (12 months) | 141.1 degrees | Standard Deviation 39.8 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | HEALICOIL™ PK Preloaded Suture Anchors Internal Rotation Angle (12 months) | 75 degrees | Standard Deviation 21.2 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | HEALICOIL™ PK Preloaded Suture Anchors External Rotation (12 months) | 59.4 degrees | Standard Deviation 25.7 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: Forward Flexion Angle (6 months) | 89 degrees | Standard Deviation 100.4 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: Internal Rotation Angle (6 months) | 60 degrees | Standard Deviation 15 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | MULTIFIX™ S Ultra Knotless Fixation System: Forward Flexion Angle (6 months) | 122.5 degrees | Standard Deviation 39.4 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | MULTIFIX™ S Ultra Knotless Fixation System: Internal Rotation Angle (6 months) | 90 degrees | — |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | MULTIFIX™ S Ultra Knotless Fixation System: External Rotation (6 months) | 59.8 degrees | Standard Deviation 25.3 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | MULTIFIX™ S Ultra Knotless Fixation System: Forward Flexion Angle (12 months) | 141.7 degrees | Standard Deviation 38.2 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | MULTIFIX™ S Ultra Knotless Fixation System: Internal Rotation Angle (12 months) | 75 degrees | Standard Deviation 21.2 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | MULTIFIX™ S Ultra Knotless Fixation System: External Rotation (12 months) | 76 degrees | Standard Deviation 21.9 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | FOOTPRINT™ Ultra PK Suture Anchor: Forward Flexion Angle (6 months) | 137.5 degrees | Standard Deviation 35.9 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | FOOTPRINT™ Ultra PK Suture Anchor: Internal Rotation Angle (6 months) | 86.3 degrees | Standard Deviation 30.9 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | FOOTPRINT™ Ultra PK Suture Anchor: External Rotation (6 months) | 50 degrees | Standard Deviation 22.7 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | FOOTPRINT™ Ultra PK Suture Anchor: Forward Flexion Angle (12 months) | 140 degrees | Standard Deviation 28.3 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | FOOTPRINT™ Ultra PK Suture Anchor: External Rotation (12 months) | 60 degrees | Standard Deviation 0 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | SPEEDSCREW™ Knotless Fixation System: Forward Flexion Angle (6 months) | 122 degrees | Standard Deviation 46 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | SPEEDSCREW™ Knotless Fixation System: External Rotation (6 months) | 35 degrees | Standard Deviation 10 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | SPEEDSCREW™ Knotless Fixation System: Forward Flexion Angle (12 months) | 130 degrees | — |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Range of Motion (ROM) | SPEEDSCREW™ Knotless Fixation System: External Rotation (12 months) | 50 degrees | — |
Secondary
Visual Analog Scale (VAS) - Pain
The VAS is a continuous scale comprised of a horizontal line 100 millimeters (mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain (0 mm) and a score of 10 indicates extreme/unbearable pain (100 mm). The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery.
Time frame: 6 and 12 months
Population: Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Visual Analog Scale (VAS) - Pain | HEALICOIL™ PK Preloaded Suture Anchors: 6 months | 1.8 score on a scale | Standard Deviation 2.1 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Visual Analog Scale (VAS) - Pain | HEALICOIL™ PK Preloaded Suture Anchors: 12 months | 2.4 score on a scale | Standard Deviation 1.8 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Visual Analog Scale (VAS) - Pain | BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 6 months | 2.5 score on a scale | Standard Deviation 2.8 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Visual Analog Scale (VAS) - Pain | BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 12 months | 4.5 score on a scale | Standard Deviation 0.7 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Visual Analog Scale (VAS) - Pain | MULTIFIX™ S Ultra Knotless Fixation System: 6 months | 2.2 score on a scale | Standard Deviation 2.1 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Visual Analog Scale (VAS) - Pain | MULTIFIX™ S Ultra Knotless Fixation System: 12 months | 2.3 score on a scale | Standard Deviation 1.9 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Visual Analog Scale (VAS) - Pain | FOOTPRINT™ Ultra PK Suture Anchor: 6 months | 2.3 score on a scale | Standard Deviation 2.1 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Visual Analog Scale (VAS) - Pain | SPEEDSCREW™ Knotless Fixation System: 6 months | 1.4 score on a scale | Standard Deviation 3.1 |
| Polyetheretherketone (PEEK) Shoulder Suture Anchors | Visual Analog Scale (VAS) - Pain | SpeedLock Knotless Fixation Device: 6 months | 0 score on a scale | Standard Deviation 0 |