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Post-market clinical follow-up (PMCF) on the PEEK Suture Anchors in the hip.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEEK Suture Anchors | Device | Subjects who have undergone hip joint repair using PEEK Suture Anchors: BIORAPTOR™ Knotless Suture Anchor and SpeedLock Hip Suture Anchor |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention | Clinical success was defined as hip repairs without signs of device failure and/or re-intervention as assessed by the surgeon (Yes/No). Specifically, clinical success was achieved with "Yes" responses on the following 3 main criteria:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 12 Months After Intervention | Clinical success was defined as hip repairs without signs of device failure and/or re-intervention as assessed by the surgeon (Yes/No). Specifically, clinical success was achieved with "Yes" responses on the following 3 main criteria:
|
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who have undergone hip joint repair using PEEK Suture Anchors:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Horner | Smith & Nephew, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DMOS Orthopedic Centers | West Des Moines | Iowa | 50266 | United States | ||
| Center for Advanced Orthopedic and Sports Medicine |
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A total of 149 participants were enrolled in the study and 150 joints were observed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Polyetheretherketone (PEEK) Hip Suture Anchors | Participants who have received PEEK Suture Anchors in the hip which included: BIORAPTOR™ Knotless Suture Anchor and SpeedLock Hip Suture Anchor |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants enrolled in the study who had previously undergone extremity repair using PEEK suture anchors (i.e., retrospective data). The type(s) of PEEK anchor used during surgery was surgeon decision on a case by case basis. Multiple anchor types could be used in one surgery if required. Two participants had multiple devices implanted. Participants with bilateral surgeries had both surgeries recorded independently. Device data analyzed individually dependent on unique suture anchor implanted.
| ID | Title | Description |
|---|---|---|
| BG000 | Polyetheretherketone (PEEK) Hip Suture Anchors | Participants who have received PEEK Suture Anchors in the hip which included: BIORAPTOR™ Knotless Suture Anchor and SpeedLock Hip Suture Anchor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention | Clinical success was defined as hip repairs without signs of device failure and/or re-intervention as assessed by the surgeon (Yes/No). Specifically, clinical success was achieved with "Yes" responses on the following 3 main criteria:
| Participants analyzed for each row indicate those with available retrospective data for the time frame & outcome specified. 2 participants implanted with multiple Suture Anchors (devices). Data analyzed independently based on 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. | Posted | Count of Participants | Participants | 6 months |
|
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 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BIORAPTOR™ Knotless Suture Anchor | Participants who have received PEEK Suture Anchors in the hip: BIORAPTOR™ Knotless Suture Anchor |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| STROKE | Blood and lymphatic system disorders | Non-systematic Assessment | Unrelated to device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ILIOPSOAS TENDENOPATHY | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith Horner | Smith + Nephew, Inc. | +44 1482 673251 | Judith.Horner@smith-nephew.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 3, 2019 | Nov 18, 2021 | Prot_SAP_000.pdf |
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| 12 months |
| 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. | 6 and 12 months |
| 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. | 6 months and 12 months |
| Range of Motion (ROM) | Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on the physician's Standard of Care. | 6 and 12 months |
| Auburn Hills |
| Michigan |
| 48326 |
| United States |
| Community Hospital - Oklahoma City | Oklahoma City | Oklahoma | 73114 | United States |
| Southwest Orthopaedic Reconstructive Specialists | Oklahoma City | Oklahoma | 73139 | United States |
| joints |
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| years |
| joints |
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| Sex: Female, Male | Count of Units | joints | joints |
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| Ethnicity (NIH/OMB) | Count of Units | joints | joints |
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| Race/Ethnicity, Customized | Count of Units | joints | joints |
|
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| Location of Device Implantation | Count of Participants | Participants | Participants |
|
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| Duration of Surgery (min) | Data only available for 20 participants due to the retrospective nature of the study. | Mean | Standard Deviation | minutes | Participants |
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| Intervention | Count of Units | joints | joints |
|
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| Duration of time from injury to surgery (days) | Data only available for 86 participants due to the retrospective nature of the study. | Mean | Standard Deviation | days | Participants |
|
|
| Any Medical History | Count of Units | joints | joints |
|
|
| OG000 | Polyetheretherketone (PEEK) Hip Suture Anchors | Participants who have received PEEK Suture Anchors in the hip which included: BIORAPTOR™ Knotless Suture Anchor and SpeedLock Hip Suture Anchor |
|
|
| Secondary | Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 12 Months After Intervention | Clinical success was defined as hip repairs without signs of device failure and/or re-intervention as assessed by the surgeon (Yes/No). Specifically, clinical success was achieved with "Yes" responses on the following 3 main criteria:
| Participants analyzed for each row indicate those with available retrospective data for the time frame & outcome specified. 2 participants implanted with multiple Suture Anchors (devices). Data analyzed independently based on 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | 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. | No data were collected at 6 months or 12 months for VAS pain score due to the retrospective nature of the study. | Posted | 6 and 12 months |
|
|
| 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. | Participants analyzed for each row indicate those with available retrospective data for the time frame & outcome specified. 2 participants implanted with multiple Suture Anchors (devices). Data analyzed independently based on 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. | Posted | Count of Participants | Participants | 6 months and 12 months |
|
|
|
| Secondary | Range of Motion (ROM) | Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on the physician's Standard of Care. | Participants analyzed for each row indicate those with available retrospective data for the time frame & outcome specified. 2 participants implanted with multiple Suture Anchors (devices). Data analyzed independently based on 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. | Posted | Mean | Standard Deviation | degrees | 6 and 12 months |
|
|
|
| 0 |
| 58 |
| 5 |
| 58 |
| 1 |
| 58 |
| EG001 | SpeedLock Hip Suture Anchor | Participants who have received PEEK Suture Anchors in the hip: SpeedLock Hip Suture Anchor | 0 | 93 | 6 | 93 | 11 | 93 |
|
| POST SURGICAL RIGHT HIP OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unlikely related to device |
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| REPEAT LEFT HIP LABRAL TEAR | Injury, poisoning and procedural complications | Non-systematic Assessment | Unlikely related to device |
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| RIGHT PSOAS TENDONITIS/SNAP | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to device |
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| LEFT HIP LABRAL ACETABULAR RETEAR | Injury, poisoning and procedural complications | Non-systematic Assessment | Unrelated to device |
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| LEFT HIP LABRAL RETEAR | Injury, poisoning and procedural complications | Non-systematic Assessment | Unlikely related to device |
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| RIGHT HIP LABRAL TEAR | Injury, poisoning and procedural complications | Non-systematic Assessment | Unlikely related to device |
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| LEFT HIP INTRA-ARTICULAR PAIN | General disorders | Non-systematic Assessment | Unrelated to device |
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| HIP LABRAL TEAR | Injury, poisoning and procedural complications | Non-systematic Assessment | Unrelated to device |
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| LEFT HIP LABRAL RETEAR | Injury, poisoning and procedural complications | Non-systematic Assessment | Unrelated to device |
|
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| RIGHT LEG PAIN | General disorders | Non-systematic Assessment | Unrelated to device |
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| HIP PAIN | General disorders | Non-systematic Assessment | Unrelated to device |
|
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| SpeedLock Hip Suture Anchor |
|
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| Has full functional arc: Unknown |
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| BIORAPTOR™ Knotless Suture Anchor: 12 months |
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| SpeedLock Hip Suture Anchor: 6 months |
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| SpeedLock Hip Suture Anchor: 12 months |
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| BIORAPTOR™ Knotless Suture Anchor: External Rotation (6 months) |
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| BIORAPTOR™ Knotless Suture Anchor: Forward Flexion Angle (12 months) |
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| BIORAPTOR™ Knotless Suture Anchor: Internal Rotation Angle (12 months) |
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| BIORAPTOR™ Knotless Suture Anchor: External Rotation (12 months) |
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| SpeedLock Hip Suture Anchor: Forward Flexion Angle (6 months) |
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| SpeedLock Hip Suture Anchor: Internal Rotation Angle (6 months) |
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| SpeedLock Hip Suture Anchor: External Rotation (6 months) |
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| SpeedLock Hip Suture Anchor: Forward Flexion Angle (12 months) |
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| SpeedLock Hip Suture Anchor: Internal Rotation Angle (12 months) |
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| SpeedLock Hip Suture Anchor: External Rotation (12 months) |
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