Achilles Tendon Repairs/Reconstructions, Bicep Tendon Reattachments, Bunionectomy, Hallux Valgus Repairs, Lateral Epicondylitis Repair, Medial or Lateral Instability Repairs/Reconstructions, Metatarsal Ligament/Tendon Repairs/Reconstructions, Midfoot Reconstructions, Scapholunate Ligament Reconstructions, Ulnar
Conditions
Keywords
Dynomite, Spyromite, Raptormite, Foot, Ankle, Wrist, Hand, Elbow, Footprint
Brief summary
Safety and performance of the study devices in extremities up to 12 months post-surgery
Interventions
DEVICESpyromite, Dynomite, Raptomite, Footprint Ultra PK SL
PEEK Suture Anchors, which include: * SPYROMITE™ 2.0 PK Suture Anchor with Needles * DYNOMITE™ 2.0 PK Suture Anchor with Needles * RAPTORMITE™ 3.0 Suture Anchor with Needles * FOOTPRINT™ Ultra PK SL Suture Anchor
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
* Subjects who have undergone extremity joint repair using the study devices. * Subjects aged 18 years and older at the time of surgery.
Exclusion criteria
* Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative. * Subjects who are \< 3 months post-operative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 6 Months After Intervention | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 12 Months After Intervention | 12 months | 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 (reintervention) on the index extremity |
Other
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) - Pain | 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. |
| 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. |
Countries
Canada, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 140 |
| 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 | 142 |
| Total | 282 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Deviation | 4 |
Baseline characteristics
| Characteristic | Polyetheretherketone (PEEK) Extremity Suture Anchors |
|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 13.6 |
| Disposition of Suture Anchors DYNOMITE™ 2.0 PK Suture Anchor with Needles | 17 Participants |
| Disposition of Suture Anchors FOOTPRINT™ Ultra PK SL Suture Anchor | 57 Participants |
| Disposition of Suture Anchors RAPTORMITE™ 3.0 PK Suture Anchor with Needles | 71 Participants |
| Duration of Surgery (min) | 67 minutes STANDARD_DEVIATION 28.5 |
| Duration of time from injury to surgery (days) | 508.4 days STANDARD_DEVIATION 994.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 joints |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 115 joints |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 21 joints |
| Location of Device Implantation Bilaterally | 4 joints |
| Location of Device Implantation Left | 72 joints |
| Location of Device Implantation Right | 66 joints |
| Number of Joints Treated by Indication Achilles tendon | 54 joints |
| Number of Joints Treated by Indication Medial instability | 58 joints |
| Number of Joints Treated by Indication Medial instability & Achilles tendon | 1 joints |
| Number of Joints Treated by Indication Medial instability & Other | 5 joints |
| Number of Joints Treated by Indication Metatarsal ligament | 11 joints |
| Number of Joints Treated by Indication Metatarsal ligament & Other | 1 joints |
| Number of Joints Treated by Indication Midfoot | 2 joints |
| Number of Joints Treated by Indication Midfoot & Metatarsal ligament | 4 joints |
| Number of Joints Treated by Indication Other | 6 joints |
| Race/Ethnicity, Customized American Indian or Alaska Native No | 142 joints |
| Race/Ethnicity, Customized American Indian or Alaska Native Yes | 0 joints |
| Race/Ethnicity, Customized Asian No | 142 joints |
| Race/Ethnicity, Customized Asian Yes | 0 joints |
| Race/Ethnicity, Customized Black or African American No | 137 joints |
| Race/Ethnicity, Customized Black or African American Yes | 5 joints |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander No | 142 joints |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander Yes | 0 joints |
| Race/Ethnicity, Customized Other No | 124 joints |
| Race/Ethnicity, Customized Other Yes | 18 joints |
| Race/Ethnicity, Customized White No | 22 joints |
| Race/Ethnicity, Customized White Yes | 120 joints |
| Sex: Female, Male Female | 83 joints |
| Sex: Female, Male Male | 59 joints |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 71 | 0 / 57 |
| other Total, other adverse events | 5 / 17 | 0 / 71 | 2 / 57 |
| serious Total, serious adverse events | 0 / 17 | 2 / 71 | 2 / 57 |
Outcome results
Primary
Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 6 Months After Intervention
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
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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
Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 12 Months After Intervention
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 (reintervention) on the index extremity
Time frame: 12 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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
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: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | 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 |
Other Pre-specified
Visual Analog Scale (VAS) - Pain
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.
Time frame: 6 and 12 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Polyetheretherketone (PEEK) Extremity Suture Anchors | Visual Analog Scale (VAS) - Pain | DYNOMITE™ 2.0 PK Suture Anchor With Needles: 6 months | 2 score on a scale | — |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | Visual Analog Scale (VAS) - Pain | RAPTORMITE™ 3.0 Suture Anchor With Needles: 6 months | 1.8 score on a scale | Standard Deviation 2.2 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | Visual Analog Scale (VAS) - Pain | RAPTORMITE™ 3.0 Suture Anchor With Needles: 12 months | 3.7 score on a scale | Standard Deviation 4 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | Visual Analog Scale (VAS) - Pain | FOOTPRINT™ Ultra PK SL Suture Anchor: 6 months | 2.6 score on a scale | Standard Deviation 2.5 |
| Polyetheretherketone (PEEK) Extremity Suture Anchors | Visual Analog Scale (VAS) - Pain | FOOTPRINT™ Ultra PK SL Suture Anchor: 12 months | 2 score on a scale | Standard Deviation 2.8 |