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This study evaluates the safety of the HEALICOIL Knotless Suture Anchors in patients requiring a repair of the rotator cuff tendon repair
This is a multicenter, prospective, post-marketing, observational, case series study to evaluate the safety and efficacy of the HEALICOIL Knotless Suture Anchors in subjects with either rotator cuff repair and/or biceps tenodesis. Approximately 160 subjects will be enrolled at up to 6 sites. Safety monitoring will include documentation device- and surgery-related AEs. Efficacy will be monitored by assessment of post-operative follow up, clinical complications, reoperation rate, EQ-5D-5L, and pain VAS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEALICOIL Knotless REGENESORB | HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB |
| |
| HEALICOIL Knotless PEEK | HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEALICOIL Knotless PEEK | Device | HEALICOIL Knotless PEEK Self-Tapping HEALICOIL Knotless Non-Self Tapping |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success Rate at 6 Months | Clinical success was identified by the repair failure rate defined as the need for a second repair procedure. The second repair procedure would be a repair of the original rotator cuff and/or biceps tenodesis from the index procedure. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success Rate at 12 Months | Clinical success identified by the repair failure rate was defined as the need for a second repair procedure. The second repair procedure would be a repair of the original rotator cuff and/or biceps tenodesis from the index procedure. | 12 months |
| Clinical Success Rate at 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor ONLY) |
Not provided
Inclusion Criteria:
Requires reattachment of soft tissue to bone for the following shoulder indications:
Rotator Cuff Tendon repair:
Biceps tenodesis
Has a pre-operative MRI collected within 6 months of surgery which meets one of the following criteria:
Has consented to participate in the study by signing the IRB/IEC approved informed consent form.
Requires only one variant of the HEALICOIL Knotless Suture Anchor
Is ≥18 years of age at time of surgery
Willing and able to make all required study visits
Able to follow instructions (Approved translated documents supplied upon request)
Exclusion Criteria:
Any one (1) of the following criteria will disqualify a potential subject from participation in the study:
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Primary Care Clinic
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| Name | Affiliation | Role |
|---|---|---|
| Karlie Morgan | Smith & Nephew, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Stanford | Redwood City | California | 94063 | United States | ||
| Orthopaedic and Spine Center of Southern Colorado |
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| ID | Title | Description |
|---|---|---|
| FG000 | HEALICOIL Knotless PEEK | HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK: HEALICOIL Knotless PEEK Self-Tapping or HEALICOIL Knotless PEEK Non-Self Tapping |
| FG001 | HEALICOIL Knotless REGENESORB | HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB: HEALICOIL Knotless REGENESORB Self-Tapping or HEALICOIL Knotless REGENESORB Non-Self Tapping |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population (SAF) included those that received the study device with data collected.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | HEALICOIL Knotless PEEK | HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK: HEALICOIL Knotless PEEK Self-Tapping or HEALICOIL Knotless PEEK Non-Self Tapping |
| BG001 | HEALICOIL Knotless REGENESORB |
| 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 | Clinical Success Rate at 6 Months | Clinical success was identified by the repair failure rate defined as the need for a second repair procedure. The second repair procedure would be a repair of the original rotator cuff and/or biceps tenodesis from the index procedure. | Safety population (SAF) included participants that received the study device with data collected for the time frame specified. | Posted | Count of Participants | Participants | 6 months |
|
Adverse events were collected during surgery to study completion, up to 24 months.
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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 | HEALICOIL Knotless PEEK | HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK: HEALICOIL Knotless PEEK Self-Tapping or HEALICOIL Knotless PEEK Non-Self Tapping |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NERVE DAMAGE | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIZZINESS | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Clinical Compliance | Smith+Nephew, Inc | 18008215700 | datasharing.gcs@smith-nephew.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 25, 2021 | Jan 9, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 3, 2024 | Jan 9, 2026 | SAP_001.pdf |
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| HEALICOIL Knotless REGENESORB | Device | HEALICOIL Knotless REGENESORB Self -Tapping HEALICOIL Knotless REGENSORB Non-Self Tapping |
|
Clinical success identified by the repair failure rate was defined as the need for a second repair procedure. The second repair procedure would be a repair of the original rotator cuff and/or biceps tenodesis from the index procedure. |
| 24 months |
| Constant-Murley Score | Constant-Murley Shoulder (CMS) scale assesses four aspects related to shoulder pathology across four domains of pain, activities of daily living (ADL), range of motion (ROM), and strength. Pain and ADL are answered by the participant. ROM and strength require a physical evaluation and are answered by the surgeon or the physiotherapist. Scores range from 0 to 100, with a higher score indicating better shoulder function (i.e., a better outcome). | Baseline, 6 months, 12 months, and 24 months |
| American Shoulder and Elbow Surgeons (ASES) Score | The ASES instrument is composed of 2 sections containing participant self-reported and clinician assessments. It is based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). The ASES score ranges from 0 to 100 with a higher score indicating improvement in pain and function (i.e., a better outcome). | Baseline, 6 months, 12 months, and 24 months |
| American Shoulder and Elbow Surgeons (ASES): Visual Analog Scale (VAS) Pain Score | The ASES instrument is composed of 2 sections containing participant self-reported and clinician assessments. It is based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). The ASES VAS Pain score ranges from 0 to 10, where 0 represented no pain and 10 represented the worst pain (i.e., a lower score is a better outcome). | Baseline, 6 months, 12 months, and 24 months |
| Single Assessment Numeric Evaluation (SANE) Shoulder Scale at 6 Months and 12 Months | The SANE is a simple, single-question, patient-based shoulder function assessment tool based on responses to the question ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?'' Scores ranged from 0 to 100, where 100 was considered normal (i.e., a better outcome). | Baseline, 6 months, 12 months, and 24 months |
| EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Index Score | The EuroQol EQ-5D-3L is composed of a descriptive system and EQ Visual Analogue Scale (EQ VAS). The descriptive system measures health-related Quality of Life (QOL) that consists of five dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored based on one of the three levels of severity (e.g., no problems, some or moderate problems, extreme problems) to create a combined Index Score. The Index Score is reported on a scale of 0 to 1 with a higher score indicating better health. | Baseline, 6 months, 12 months, and 24 months |
| EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Visual Analogue Scale (VAS) Score | The EuroQol EQ-5D-3L is composed of the descriptive system and EQ Visual Analogue Scale (EQ VAS). The EQ VAS was the participants self-rated health scored on a scale of 0 to 100 with 0 indicating 'the worst health you can imagine' and 100 indicating 'the best health you can imagine' (i.e., a higher score is a better outcome). | Baseline, 6 months, 12 months, and 24 months |
| Tendon Thickening at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY) | Magnetic Resonance Imaging (MRI) was used to determine tendon thickening in millimeters (mm) for the supraspinatus tendon at the Lateral Anterior, Lateral Posterior, Medial Anterior, and Medial Posterior locations at 6 months and 24 months. Lateral measurements were taken from the lateral end of the supraspinatus tendon, about 5mm to the bony insertion site. Medial measurements considered the medial end of the supraspinatus tendon, about 5mm lateral to the musculotendinous junction. | 6 months and 24 months |
| Tendon Re-tear Status at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY) | Magnetic Resonance Imaging (MRI) was used to determine participant tendon Re-tear Status at 6 months and 24 months. Re-tear Status was categorized as either 'Absent' or 'Present' based on the Re-tear Type assessment. 'Absent' indicated a Re-tear Type graded as 'Intact', 'Low-grade Partial-Thickness Tear', or 'High-grade Partial-Thickness Tear'. 'Present' indicated a Re-tear Type graded as 'Full-Thickness Tear'. | 6 months and 24 months |
| Colorado Springs |
| Colorado |
| 80920 |
| United States |
| University of Colorado - Denver | Denver | Colorado | 80222 | United States |
| OrthoIllinois LTD | Rockford | Illinois | 61107 | United States |
| University Orthopedics Center | Altoona | Pennsylvania | 16602 | United States |
| Withdrawal by Subject |
|
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB: HEALICOIL Knotless REGENESORB Self-Tapping or HEALICOIL Knotless REGENESORB Non-Self Tapping |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Data necessary for BMI not collected for 11 participants in HEALICOIL Knotless REGENESORB and will not be reported. | Mean | Standard Deviation | kg/m^2 |
|
| Type of HEALICOIL Knotless Suture Anchor | The number of participants by the type of HEALICOIL Knotless PEEK or REGENESORB Suture Anchor received were categorized as one of the flowing:
| Count of Participants | Participants |
|
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB: HEALICOIL Knotless REGENESORB Self-Tapping or HEALICOIL Knotless REGENESORB Non-Self Tapping |
|
|
| Secondary | Clinical Success Rate at 12 Months | Clinical success identified by the repair failure rate was defined as the need for a second repair procedure. The second repair procedure would be a repair of the original rotator cuff and/or biceps tenodesis from the index procedure. | Safety population (SAF) included participants that received the study device with data collected for the time frame specified. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Clinical Success Rate at 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor ONLY) | Clinical success identified by the repair failure rate was defined as the need for a second repair procedure. The second repair procedure would be a repair of the original rotator cuff and/or biceps tenodesis from the index procedure. | Safety population (SAF) included participants with data collected for the study device indicated. Data collection at 24 months only applied to participants receiving the HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor type as specified in the protocol (i.e., data at 24 months was only reported for HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor participants with data collected) | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Constant-Murley Score | Constant-Murley Shoulder (CMS) scale assesses four aspects related to shoulder pathology across four domains of pain, activities of daily living (ADL), range of motion (ROM), and strength. Pain and ADL are answered by the participant. ROM and strength require a physical evaluation and are answered by the surgeon or the physiotherapist. Scores range from 0 to 100, with a higher score indicating better shoulder function (i.e., a better outcome). | Full Analysis Set (FAS) population followed the intention-to-treat principle for participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame specified. Data reported at 24 months only applied to participants receiving the HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor type as specified in the protocol (i.e., data reported at 24 months is the data collected for Non-Self Tapping Suture Anchor participants only). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 12 months, and 24 months |
|
|
|
| Secondary | American Shoulder and Elbow Surgeons (ASES) Score | The ASES instrument is composed of 2 sections containing participant self-reported and clinician assessments. It is based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). The ASES score ranges from 0 to 100 with a higher score indicating improvement in pain and function (i.e., a better outcome). | Full Analysis Set (FAS) population followed the intention-to-treat principle for participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame specified. Data reported at 24 months only applied to participants receiving the HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor type as specified in the protocol (i.e., data reported at 24 months is the data collected for Non-Self Tapping Suture Anchor participants only). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 12 months, and 24 months |
|
|
|
| Secondary | American Shoulder and Elbow Surgeons (ASES): Visual Analog Scale (VAS) Pain Score | The ASES instrument is composed of 2 sections containing participant self-reported and clinician assessments. It is based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). The ASES VAS Pain score ranges from 0 to 10, where 0 represented no pain and 10 represented the worst pain (i.e., a lower score is a better outcome). | Full Analysis Set (FAS) population followed the intention-to-treat principle for participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame specified. Data reported at 24 months only applied to participants receiving the HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor type as specified in the protocol (i.e., data reported at 24 months is the data collected for Non-Self Tapping Suture Anchor participants only). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 12 months, and 24 months |
|
|
|
| Secondary | Single Assessment Numeric Evaluation (SANE) Shoulder Scale at 6 Months and 12 Months | The SANE is a simple, single-question, patient-based shoulder function assessment tool based on responses to the question ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?'' Scores ranged from 0 to 100, where 100 was considered normal (i.e., a better outcome). | Full Analysis Set (FAS) population followed the intention-to-treat principle for participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame specified. The 24-month time frame only applied to participants receiving HEALICOIL Knotless Suture REGENESORB Non-Self Tapping suture anchor (i.e., data not reported at 24 months for HEALICOIL Knotless PEEK because it was not collected per the protocol). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 12 months, and 24 months |
|
|
|
| Secondary | EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Index Score | The EuroQol EQ-5D-3L is composed of a descriptive system and EQ Visual Analogue Scale (EQ VAS). The descriptive system measures health-related Quality of Life (QOL) that consists of five dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored based on one of the three levels of severity (e.g., no problems, some or moderate problems, extreme problems) to create a combined Index Score. The Index Score is reported on a scale of 0 to 1 with a higher score indicating better health. | Full Analysis Set (FAS) population followed the intention-to-treat principle for participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame specified. Data reported at 24 months only applied to participants receiving the HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor type as specified in the protocol (i.e., data reported at 24 months is the data collected for Non-Self Tapping Suture Anchor participants only). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 12 months, and 24 months |
|
|
|
| Secondary | EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Visual Analogue Scale (VAS) Score | The EuroQol EQ-5D-3L is composed of the descriptive system and EQ Visual Analogue Scale (EQ VAS). The EQ VAS was the participants self-rated health scored on a scale of 0 to 100 with 0 indicating 'the worst health you can imagine' and 100 indicating 'the best health you can imagine' (i.e., a higher score is a better outcome). | Full Analysis Set (FAS) population followed the intention-to-treat principle for participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame specified. Data reported at 24 months only applied to participants receiving the HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor type as specified in the protocol (i.e., data reported at 24 months is the data collected for Non-Self Tapping Suture Anchor participants only). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 12 months, and 24 months |
|
|
|
| Secondary | Tendon Thickening at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY) | Magnetic Resonance Imaging (MRI) was used to determine tendon thickening in millimeters (mm) for the supraspinatus tendon at the Lateral Anterior, Lateral Posterior, Medial Anterior, and Medial Posterior locations at 6 months and 24 months. Lateral measurements were taken from the lateral end of the supraspinatus tendon, about 5mm to the bony insertion site. Medial measurements considered the medial end of the supraspinatus tendon, about 5mm lateral to the musculotendinous junction. | Safety Analysis (SAF) population included participants receiving the indicated study device with data collected for the time frame specified. MRI Data reported at 6 months and 24 months only applied to participants receiving the HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor type as specified in the protocol (i.e., data reported is the data collected for Non-Self Tapping Suture Anchor participants only). | Posted | Mean | Standard Deviation | millimeters (mm) | 6 months and 24 months |
|
|
|
| Secondary | Tendon Re-tear Status at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY) | Magnetic Resonance Imaging (MRI) was used to determine participant tendon Re-tear Status at 6 months and 24 months. Re-tear Status was categorized as either 'Absent' or 'Present' based on the Re-tear Type assessment. 'Absent' indicated a Re-tear Type graded as 'Intact', 'Low-grade Partial-Thickness Tear', or 'High-grade Partial-Thickness Tear'. 'Present' indicated a Re-tear Type graded as 'Full-Thickness Tear'. | Safety Analysis (SAF) population included participants receiving the indicated study device with data collected for the time frame specified. MRI Data reported at 6 months and 24 months only applied to participants receiving the HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor type as specified in the protocol (i.e., data reported is the data collected for Non-Self Tapping Suture Anchor participants only). | Posted | Count of Participants | Participants | 6 months and 24 months |
|
|
|
| 0 |
| 66 |
| 6 |
| 66 |
| 14 |
| 66 |
| EG001 | HEALICOIL Knotless REGENESORB | HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB: HEALICOIL Knotless REGENESORB Self-Tapping or HEALICOIL Knotless REGENESORB Non-Self Tapping | 0 | 72 | 14 | 72 | 32 | 72 |
| HEMORRHAGIC STROKE | Nervous system disorders | Systematic Assessment |
|
| ARTERIOSCLEROSIS/ ATHEROSCLEROSIS | Vascular disorders | Systematic Assessment |
|
| UNSPECIFIED HEART PROBLEM | Cardiac disorders | Systematic Assessment |
|
| NASAL OBSTRUCTION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| CATARACT | Eye disorders | Systematic Assessment |
|
| UNSPECIFIED GASTROINTESTINAL PROBLEM | Gastrointestinal disorders | Systematic Assessment |
|
| ARTHRITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| BONE FRACTURE(S) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| DAMAGE TO LIGAMENT(S) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| LOSS OF RANGE OF MOTION | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| MUSCLE/TENDON DAMAGE | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| OSTEOLYSIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| UNSPECIFIED MUSCULOSKELETAL PROBLEM | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| BONE FRACTURE(S) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| RUPTURE | Injury, poisoning and procedural complications | Systematic Assessment |
|
| PAIN | General disorders | Systematic Assessment |
|
| HEADACHE | General disorders | Systematic Assessment |
|
| SYNCOPE/FAINTING | Nervous system disorders | Systematic Assessment |
|
| SHAKING/TREMORS | Nervous system disorders | Systematic Assessment |
|
| NERVE DAMAGE | Nervous system disorders | Systematic Assessment |
|
| NEUROPATHY | Nervous system disorders | Systematic Assessment |
|
| SLEEP DYSFUNCTION | Nervous system disorders | Systematic Assessment |
|
| SPEECH DISORDER | Nervous system disorders | Systematic Assessment |
|
| STROKE/CVA | Nervous system disorders | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | Systematic Assessment |
|
| LOCAL REACTION | Immune system disorders | Systematic Assessment |
|
| ANEURYSM | Vascular disorders | Systematic Assessment |
|
| VALVULAR STENOSIS | Cardiac disorders | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| RESPIRATORY TRACT INFECTION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| UNSPECIFIED RESPIRATORY PROBLEM | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| PARTIAL HEARING LOSS | Ear and labyrinth disorders | Systematic Assessment |
|
| ABDOMINAL PAIN | General disorders | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | Systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | Systematic Assessment |
|
| UNSPECIFIED GASTROINTESTINAL PROBLEM | Gastrointestinal disorders | Systematic Assessment |
|
| URINARY FREQUENCY | Renal and urinary disorders | Systematic Assessment |
|
| INTERMENSTRUAL BLEEDING | Reproductive system and breast disorders | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| ARTHRITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| CRAMP(S) /MUSCLE SPASM(S) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| LOSS OF RANGE OF MOTION | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| MUSCLE/TENDON DAMAGE | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| OSTEOPENIA/ OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| SPINAL COLUMN INJURY | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| UNSPECIFIED MUSCULOSKELETAL PROBLEM | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| ITCHING SENSATION | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| LOCALIZED SKIN LESION | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| CONTACT DERMATITIS | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| CYST(S) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| NODULE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| VIRAL INFECTION | Infections and infestations | Systematic Assessment |
|
| LACERATION(S) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| RUPTURE | Injury, poisoning and procedural complications | Systematic Assessment |
|
| ADHESION(S) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| POST OPERATIVE WOUND INFECTION | Injury, poisoning and procedural complications | Systematic Assessment |
|
| HIGH BLOOD PRESSURE/ HYPERTENSION | General disorders | Systematic Assessment |
|
| INFLAMMATION | General disorders | Systematic Assessment |
|
| OBSTRUCTION/OCCLUSION | General disorders | Systematic Assessment |
|
| PAIN | General disorders | Systematic Assessment |
|
| SWELLING/ EDEMA | General disorders | Systematic Assessment |
|
| APPROPRIATE TERM / CODE NOT AVAILABLE | General disorders | Systematic Assessment |
|
The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period up to 90 days but less than or equal to 180 days from the time submitted to the sponsor for review. Sponsor may delay publication up to 180 days to permit the filing of appropriate patent applications if the sponsor believes any publication contains any information relating to patentable items and cannot extend the embargo.
| Unknown or Not Reported |
|
| Black or African American |
|
| White |
|
| Other |
|
| 6 months |
|
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| 12 months |
|
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| 24 months |
|
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| 6 months |
|
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| 12 months |
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| 24 months |
|
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| 6 months |
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| 12 months |
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| 24 months |
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| 6 months |
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| 12 months |
|
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| 24 months |
|
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| 6 months |
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| 12 months |
|
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| 24 months |
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| 6 months |
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|
| 12 months |
|
|
| 24 months |
|
|
|
| 6 months: Medial Anterior |
|
|
| 6 months: Medial Posterior |
|
|
| 24 months: Lateral Anterior |
|
|
| 24 months: Lateral Posterior |
|
|
| 24 months: Medial Anterior |
|
|
| 24 months: Medial Posterior |
|
|
| 24 months |
|
|