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The scientific justification is to fulfill post-market clinical requirements in order to support re-certification of the CE-Mark for this marketed product and to look into safety and efficacy.
Shoulder: The superior labrum (fibrous cartilage) and biceps anchor improve joint stability by acting like a secondary stabilizer to the shoulder. Labral injuries are usually associated with anterior shoulder dislocation. When conservative treatment fails, such as physical therapy, strengthening programs, anti-inflammatories and activity modification to improve symptoms, surgical intervention may be required. Surgical treatments can include simple debridement, stabilization of the biceps-labrum complex through repair, or biceps tenodesis where the end of a tendon is joined surgically to the bone. Outcomes of SLAP (superior labral tear from anterior to posterior) repairs have been reported good throughout the literature, with reported success rates ranging from 71-97%.
Hip: The labrum of the hip is a fibrocartilaginous tissue that connects to the bone edge of the acetabulum (the socket of the hip bone), and deepens the acetabular socket while extending coverage of the femoral head; it also aids in hip stabilization. The goal of surgical intervention is to restore normal hip mechanics and treat existing damage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arthroscopic hip and shoulder repair |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor | Device | Fixation device intended to provide secure fixation of soft tissue to bone |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success at 6 Months | Number of participants without signs of failure and/or re-intervention as assessed by the surgeon. | 6 month post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success at 12 Months | Number of participants without signs of failure and/or re-intervention at 12 months, as assessed by the surgeon. | 12 months post-operative |
| Intra-operative Anchor Deployment Success |
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Inclusion Criteria:
Subject has consented to participate in the study by signing the EC-approved informed consent form
Subject condition meets proposed indication to SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchor
Subject requiring shoulder or hip arthroscopic labral repair surgery from physical findings, subject symptoms and radiographic finding
Hip subjects only:
Shoulder subjects only:
Exclusion Criteria:
Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1 (pre-operative)
Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures
Contraindications or hypersensitivity to the use of the SUTUREFIX ULTRA and/or SUTUREFIX CURVED Suture Anchor, or their components (e.g. silicone, polyester). Where material sensitivity is suspected, appropriate tests should be performed and sensitivity ruled out prior to implantation
Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation
Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture
Comminuted bone surface, which would compromise secure anchor fixation
Hip subjects only:
Shoulder subjects only:
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Subject with hip or shoulder instability
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| Name | Affiliation | Role |
|---|---|---|
| Laura Everson | Smith & Nephew Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Langone Orthopaedic Center | New York | New York | 10016 | United States | ||
| Orthotennessee |
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Overall, 83 participants (42 hips / 41 shoulders) were enrolled and received the investigational product (IP) at 9 sites.
Participants were enrolled form 07 November 2018 to 21 May 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arthroscopic Hip and Shoulder Repair | SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor: Fixation device intended to provide secure fixation of soft tissue to bone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | May 9, 2018 |
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Number of suture anchors that were successfully deployed to bone, soft tissues, or both.
| Intraoperatively |
| Intraoperative Suture Anchor Failure | Suture anchor failures categorized by number of participants with:
| Intraoperatively |
| Device-related Re-Intervention | Number of participants with a device-related adverse event (AE) that required a re-intervention due to the device-related AE. | 12 months |
| Visual Analog Scale (VAS) Pain Score - All Participants | Assessed participant pain using Visual Analog Scale (VAS) assessments taken 6 and 12 months postoperative intervals. The VAS Pain Score was based on a scale of 0 to 10, with 0 representing no pain and 10 the worst possible pain. Note: This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference. | 6 and 12 months postoperative |
| Visual Analog Scale (VAS) Satisfaction Score - All Participants | Assessed participant satisfaction using a Visual Analog Scale (VAS) assessments taken at 6 and 12 month postoperative intervals. The VAS Subject Satisfaction Questionnaire was based on a scale of 0 to 10, with 0 representing very satisfied and 10 very unsatisfied. This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference. | 6 and 12 months postoperative |
| Analysis of EQ-5D-5L Index - All Participants | The EQ-5D-5L Index Score was based on a scale of 0 to 1, with higher index values indicating better health and lower index values indicating worse health. This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference. | 6 months and 12 months postoperative |
| Analysis of Hip Outcome Score Activities of Daily Living (HOOS-ADL) - Hip Participants | The Hip Outcome Score Activities of Daily Living (HOOS-ADL) Score included 5 domains (Symptoms, Pain, Daily Living, Sport & Recreation and Quality of Life) each assessed at 6 and 12 months postoperative. Each HOOS domain range was based on a scale of 0 to 100, where 0 represents extreme symptoms and 100 represents no symptoms. | 6 and 12 months postoperative |
| Modified Harris Hip Score (mHHS) - Hip Participants | The Modified Harris Hip Score (mHHS) is a measurement of dysfunction; the higher the score, the better the outcome. The mHHS score range was as follows:
This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference. | Preoperative, 6 and 12 months Postoperative |
| Rowe Score - Shoulder Participants | The Rowe Scores address categories of shoulder stability, motion, and function. Scores range from 0 to 100 with a score of 90 to 100 points indicating an excellent evaluation, 75 to 89 points indicating a good evaluation, 51 to 74 points indicating a fair evaluation, and 0 to 50 points indicating a poor evaluation. This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference. | 6 and 12 months postoperative |
| American Shoulder and Elbow Surgeons Score - Shoulder Participants | The American Shoulder and Elbow Surgeons Score (ASES) was based on a scale of 0 to 100 points, where 0 indicated a worse shoulder condition and 100 indicated a better shoulder condition | 6 and 12 months postoperative |
| Constant-Murley Shoulder Scores (CMS) - Shoulder Participants | The Constant-Murley Shoulder Score (CMS) was based on a scale of 0 to 100 points divided into 4 subscales; pain (15 points), Activities of Daily Living (20 points), strength (25 points), and Range of Motion, including: forward elevation, external rotation, abduction, and internal rotation (40 points). The higher the score, the higher the quality of the function (less disability). | 6 months and 12 months Postoperative |
| Knoxville |
| Tennessee |
| 37922 |
| United States |
| CPH Privathospital | Farum | 3520 | Denmark |
| Pihlajalinna Turku Hospital | Turku | 20100 | Finland |
| Azienda Ospedaliera San Camillo Forlanini | Roma | 00152 | Italy |
| Asepeyo Hospital Sant Cugat | Sant Cugat del Vallès | Barcelona | 08174 | Spain |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Queen Alexandra Hospital | Cosham | PO6 3LY | United Kingdom |
| Fortius Clinic | London | W1H 6EQ | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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Data available from the Safety Population (SAF) included all participants that received the investigational product (IP).
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| ID | Title | Description |
|---|---|---|
| BG000 | Arthroscopic Hip and Shoulder Repair | SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor: Fixation device intended to provide secure fixation of soft tissue to bone |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| 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 | Clinical Success at 6 Months | Number of participants without signs of failure and/or re-intervention as assessed by the surgeon. | Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment. | Posted | Count of Participants | Participants | 6 month post-surgery |
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| ||||||||||||||||||||||||||
| Secondary | Clinical Success at 12 Months | Number of participants without signs of failure and/or re-intervention at 12 months, as assessed by the surgeon. | Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment. | Posted | Count of Participants | Participants | 12 months post-operative |
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| Secondary | Intra-operative Anchor Deployment Success | Number of suture anchors that were successfully deployed to bone, soft tissues, or both. | Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment. | Posted | Count of Units | suture anchors | Intraoperatively | suture anchors | suture anchors |
|
| |||||||||||||||||||||||||
| Secondary | Intraoperative Suture Anchor Failure | Suture anchor failures categorized by number of participants with:
| Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment. | Posted | Count of Participants | Participants | No | Intraoperatively |
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| ||||||||||||||||||||||||||
| Secondary | Device-related Re-Intervention | Number of participants with a device-related adverse event (AE) that required a re-intervention due to the device-related AE. | Participants from the Safety Population (SAF) utilized for this assessment. SAF included participants that received the investigational product (IP). Additionally, this assessment only included participants from the SAF population with a device-related adverse event (AE). | Posted | Count of Participants | Participants | 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Visual Analog Scale (VAS) Pain Score - All Participants | Assessed participant pain using Visual Analog Scale (VAS) assessments taken 6 and 12 months postoperative intervals. The VAS Pain Score was based on a scale of 0 to 10, with 0 representing no pain and 10 the worst possible pain. Note: This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference. | Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment for the time frames specified. | Posted | Mean | Standard Deviation | score on a scale | 6 and 12 months postoperative |
|
| ||||||||||||||||||||||||||
| Secondary | Visual Analog Scale (VAS) Satisfaction Score - All Participants | Assessed participant satisfaction using a Visual Analog Scale (VAS) assessments taken at 6 and 12 month postoperative intervals. The VAS Subject Satisfaction Questionnaire was based on a scale of 0 to 10, with 0 representing very satisfied and 10 very unsatisfied. This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference. | Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment for the time frames specified.. | Posted | Mean | Standard Deviation | score on a scale | 6 and 12 months postoperative |
|
| ||||||||||||||||||||||||||
| Secondary | Analysis of EQ-5D-5L Index - All Participants | The EQ-5D-5L Index Score was based on a scale of 0 to 1, with higher index values indicating better health and lower index values indicating worse health. This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference. | Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment for the time frames specified. | Posted | Mean | Standard Deviation | score on a scale | 6 months and 12 months postoperative |
|
| ||||||||||||||||||||||||||
| Secondary | Analysis of Hip Outcome Score Activities of Daily Living (HOOS-ADL) - Hip Participants | The Hip Outcome Score Activities of Daily Living (HOOS-ADL) Score included 5 domains (Symptoms, Pain, Daily Living, Sport & Recreation and Quality of Life) each assessed at 6 and 12 months postoperative. Each HOOS domain range was based on a scale of 0 to 100, where 0 represents extreme symptoms and 100 represents no symptoms. | Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment for the time frames specified. | Posted | Mean | Standard Deviation | score on a scale | 6 and 12 months postoperative |
|
| ||||||||||||||||||||||||||
| Secondary | Modified Harris Hip Score (mHHS) - Hip Participants | The Modified Harris Hip Score (mHHS) is a measurement of dysfunction; the higher the score, the better the outcome. The mHHS score range was as follows:
This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference. | Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment for the time frames specified. | Posted | Mean | Standard Deviation | score on a scale | Preoperative, 6 and 12 months Postoperative |
|
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| Secondary | Rowe Score - Shoulder Participants | The Rowe Scores address categories of shoulder stability, motion, and function. Scores range from 0 to 100 with a score of 90 to 100 points indicating an excellent evaluation, 75 to 89 points indicating a good evaluation, 51 to 74 points indicating a fair evaluation, and 0 to 50 points indicating a poor evaluation. This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference. | Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment for the time frames specified.. | Posted | Mean | Standard Deviation | score on a scale | 6 and 12 months postoperative |
|
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| Secondary | American Shoulder and Elbow Surgeons Score - Shoulder Participants | The American Shoulder and Elbow Surgeons Score (ASES) was based on a scale of 0 to 100 points, where 0 indicated a worse shoulder condition and 100 indicated a better shoulder condition | Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment for the time frames specified. | Posted | Mean | Standard Deviation | score on a scale | 6 and 12 months postoperative |
|
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| Secondary | Constant-Murley Shoulder Scores (CMS) - Shoulder Participants | The Constant-Murley Shoulder Score (CMS) was based on a scale of 0 to 100 points divided into 4 subscales; pain (15 points), Activities of Daily Living (20 points), strength (25 points), and Range of Motion, including: forward elevation, external rotation, abduction, and internal rotation (40 points). The higher the score, the higher the quality of the function (less disability). | Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment for the time frames specified. | Posted | Mean | Standard Deviation | score on a scale | 6 months and 12 months Postoperative |
|
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Time of surgery through 12 months postoperative visit
Adverse Events (AEs) and Device Deficiencies (DDs) were reported and assessed by the Investigators and were additionally analysed and classified by the Sponsor. All AEs presented were finalized on the Adverse Event Monitoring Board (AEMB) Sponsor classifications. This independent review was conducted per ISO 14155 standards. Both the Investigator AE assessment and the Smith+Nephew AEMB independent safety review are included.
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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 | Arthroscopic Hip and Shoulder Repair | SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor: Fixation device intended to provide secure fixation of soft tissue to bone | 0 | 83 | 4 | 83 | 13 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| POSTRAUMATIC DISLOCATION LEFT SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| INCREASED PAIN RIGHT HIP | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| NERUOPRAXIA AND PAIN | Nervous system disorders | Systematic Assessment |
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| RECURRENT INSTABILITY | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE PAIN RIGHT HIP | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| HIP HURTING AND CLICKING INTERMITTENTLY | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| GUARDING AROUND LEFT HIP ON EXAMINATION | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| MISLOCATION OF DEVICE / LABRUM FAILURE | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| INCREASED PAIN 7 MONTHS POST OP | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| INCREASED PAIN 3 MONTHS POST OP | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| NUMBNESS OF OPER FOOT | Nervous system disorders | Systematic Assessment |
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| TISSUE DAMAGE | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| PARTIAL PARONEAL NERVE PARESIS | Nervous system disorders | Systematic Assessment |
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| RIGHT SHOULDER STIFFNESS. | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| GLENOHUMERAL OSTEOARTHRITIS IN RIGHT S. | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| CORONA VIRUS / COVID | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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COVID-19 pandemic impacted the study causing delays on obtaining outcome and safety data at follow-up visits for participants due to site closures and/or site restrictions. There was also an impact on participant retention due to the pandemic with participants being lost to follow-up and/or out of window visits leading to protocol deviations. Patient Reported Outcomes (PROs) were optional & used according to surgeon preference leading to low response rates.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Everson | Smith+Nephew | +447718320892 | laura.everson@smith-nephew.com |
| Apr 25, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007593 | Joint Instability |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Other |
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| suture anchors |
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