Soft Tissue to Bone Fixation
Conditions
Brief summary
Post-market clinical follow-up (PMCF) on the PEEK Suture Anchors in the hip.
Interventions
DEVICEPEEK Suture Anchors
Subjects who have undergone hip joint repair using PEEK Suture Anchors: BIORAPTOR™ Knotless Suture Anchor and SpeedLock Hip 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
1. Subjects who have undergone hip joint repair using the study devices. 2. Subjects aged 18 years and older at the time of surgery. 3. Subjects who had a visit to their provider between 3 and 15 months postoperative.
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 3. Subject had off-label use of the PEEK suture anchor during surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention | 6 months | 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: * no inflammatory or allergic response * no device-related adverse event (AE) * no device deficiencies (DDs) leading to revision surgery (reintervention) on the index hip |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 12 Months After Intervention | 12 months | 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: * no inflammatory or allergic response * no device-related adverse event (AE) * no device deficiencies (DDs) leading to revision surgery (reintervention) on the index hip |
| 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 months 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 the physician's Standard of Care. |
Countries
United States
Participant flow
Pre-assignment details
A total of 149 participants were enrolled in the study and 150 joints were observed.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 149 |
| 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 | 150 |
| Total | 299 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol deviation | 1 |
Baseline characteristics
| Characteristic | Polyetheretherketone (PEEK) Hip Suture Anchors |
|---|---|
| Age, Continuous | 38 years STANDARD_DEVIATION 11.9 |
| Any Medical History No | 55 joints |
| Any Medical History Yes | 95 joints |
| Duration of Surgery (min) | 87.4 minutes STANDARD_DEVIATION 11.9 |
| Duration of time from injury to surgery (days) | 905.6 days STANDARD_DEVIATION 823.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 joints |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 97 joints |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 52 joints |
| Intervention Arthroscopic | 150 joints |
| Intervention Open | 0 joints |
| Intervention Unknown | 0 joints |
| Location of Device Implantation Bilaterally | 1 Participants |
| Location of Device Implantation Left Hip | 71 Participants |
| Location of Device Implantation Right Hip | 77 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native No | 149 joints |
| Race/Ethnicity, Customized American Indian or Alaska Native Yes | 1 joints |
| Race/Ethnicity, Customized Asian No | 150 joints |
| Race/Ethnicity, Customized Asian Yes | 0 joints |
| Race/Ethnicity, Customized Black or African American No | 147 joints |
| Race/Ethnicity, Customized Black or African American Yes | 3 joints |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander No | 150 joints |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander Yes | 0 joints |
| Race/Ethnicity, Customized Other No | 147 joints |
| Race/Ethnicity, Customized Other Yes | 3 joints |
| Race/Ethnicity, Customized White No | 6 joints |
| Race/Ethnicity, Customized White Yes | 144 joints |
| Sex: Female, Male Female | 105 joints |
| Sex: Female, Male Male | 45 joints |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 93 |
| other Total, other adverse events | 1 / 58 | 11 / 93 |
| serious Total, serious adverse events | 5 / 58 | 6 / 93 |
Outcome results
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: * no inflammatory or allergic response * no device-related adverse event (AE) * no device deficiencies (DDs) leading to revision surgery (reintervention) on the index hip
Time frame: 6 months
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Polyetheretherketone (PEEK) Hip Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention | BIORAPTOR™ Knotless Suture Anchor | Yes | 58 Participants |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention | BIORAPTOR™ Knotless Suture Anchor | No | 0 Participants |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention | SpeedLock Hip Suture Anchor | Yes | 93 Participants |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention | SpeedLock Hip Suture Anchor | 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 months and 12 months
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Polyetheretherketone (PEEK) Hip Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | BIORAPTOR™ Knotless Suture Anchor: 6 months | Has full functional arc: Yes | 18 Participants |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | BIORAPTOR™ Knotless Suture Anchor: 6 months | Has full functional arc: No | 10 Participants |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | BIORAPTOR™ Knotless Suture Anchor: 6 months | Has full functional arc: Unknown | 0 Participants |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | BIORAPTOR™ Knotless Suture Anchor: 12 months | Has full functional arc: Yes | 8 Participants |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | BIORAPTOR™ Knotless Suture Anchor: 12 months | Has full functional arc: No | 7 Participants |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | BIORAPTOR™ Knotless Suture Anchor: 12 months | Has full functional arc: Unknown | 0 Participants |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | SpeedLock Hip Suture Anchor: 6 months | Has full functional arc: Yes | 47 Participants |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | SpeedLock Hip Suture Anchor: 6 months | Has full functional arc: No | 14 Participants |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | SpeedLock Hip Suture Anchor: 6 months | Has full functional arc: Unknown | 17 Participants |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | SpeedLock Hip Suture Anchor: 12 months | Has full functional arc: Yes | 4 Participants |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | SpeedLock Hip Suture Anchor: 12 months | Has full functional arc: No | 4 Participants |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Count of Participants With Range of Motion (ROM) Full Functional Arc | SpeedLock Hip Suture Anchor: 12 months | Has full functional arc: Unknown | 10 Participants |
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: * no inflammatory or allergic response * no device-related adverse event (AE) * no device deficiencies (DDs) leading to revision surgery (reintervention) on the index hip
Time frame: 12 months
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Polyetheretherketone (PEEK) Hip Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 12 Months After Intervention | BIORAPTOR™ Knotless Suture Anchor | Yes | 42 Participants |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 12 Months After Intervention | BIORAPTOR™ Knotless Suture Anchor | No | 0 Participants |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 12 Months After Intervention | SpeedLock Hip Suture Anchor | Yes | 24 Participants |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 12 Months After Intervention | SpeedLock Hip Suture Anchor | No | 0 Participants |
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.
Time frame: 6 and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Polyetheretherketone (PEEK) Hip Suture Anchors | Range of Motion (ROM) | BIORAPTOR™ Knotless Suture Anchor: Forward Flexion Angle (6 months) | 97.5 degrees | Standard Deviation 6.3 |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Range of Motion (ROM) | BIORAPTOR™ Knotless Suture Anchor: Internal Rotation Angle (6 months) | 10.0 degrees | Standard Deviation 0 |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Range of Motion (ROM) | BIORAPTOR™ Knotless Suture Anchor: External Rotation (6 months) | 37.5 degrees | Standard Deviation 10.6 |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Range of Motion (ROM) | BIORAPTOR™ Knotless Suture Anchor: Forward Flexion Angle (12 months) | 102.9 degrees | Standard Deviation 12.5 |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Range of Motion (ROM) | BIORAPTOR™ Knotless Suture Anchor: Internal Rotation Angle (12 months) | 35.0 degrees | Standard Deviation 7.1 |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Range of Motion (ROM) | BIORAPTOR™ Knotless Suture Anchor: External Rotation (12 months) | 40.0 degrees | Standard Deviation 0 |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Range of Motion (ROM) | SpeedLock Hip Suture Anchor: Forward Flexion Angle (6 months) | 102.9 degrees | Standard Deviation 31.8 |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Range of Motion (ROM) | SpeedLock Hip Suture Anchor: Internal Rotation Angle (6 months) | 27.5 degrees | Standard Deviation 24.7 |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Range of Motion (ROM) | SpeedLock Hip Suture Anchor: External Rotation (6 months) | 35.0 degrees | Standard Deviation 14.1 |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Range of Motion (ROM) | SpeedLock Hip Suture Anchor: Forward Flexion Angle (12 months) | 112.8 degrees | Standard Deviation 11.7 |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Range of Motion (ROM) | SpeedLock Hip Suture Anchor: Internal Rotation Angle (12 months) | 16.0 degrees | Standard Deviation 8.5 |
| Polyetheretherketone (PEEK) Hip Suture Anchors | Range of Motion (ROM) | SpeedLock Hip Suture Anchor: External Rotation (12 months) | 38.5 degrees | Standard Deviation 9.2 |
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.
Time frame: 6 and 12 months
Population: No data were collected at 6 months or 12 months for VAS pain score due to the retrospective nature of the study.