Not provided
Not provided
Not provided
Not provided
Not provided
Slow enrollment resulted in the decision to prematurely terminate the study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to understand the benefits and safety of the NOVOSTITCH PRO Meniscal Repair (NOVOSTITCH PRO) system. The meniscus is a tissue in the knee joint. The NOVOSTITCH PRO is used during surgery to fix meniscus tears in the knee. It is unknown whether fixing a meniscus tear is better than the approach of removing the tear. Data will be collected on participants prior to surgery, at surgery, and for 2 years after surgery.
The purpose of this study is to understand the benefits and safety of the NOVOSTITCH PRO Meniscal Repair (NOVOSTITCH PRO) system. The meniscus is a tissue in the knee joint. The NOVOSTITCH PRO is used during surgery to fix meniscus tears in the knee. It is unknown whether fixing a meniscus tear is better than the approach of removing the tear. Data will be collected on participants prior to surgery, at surgery, and for 2 years after surgery.
There are different types of tears in the meniscus. This study includes 2 of the tear types: horizontal cleavage and complex meniscal tears.
Participants will be consented and enrolled in the study prior to knee surgery. Participants will complete surveys before surgery and data obtained from the medical record. In addition, standard of care x-rays and MRIs of the knee will be sent to the study. Participants will have their standard of care surgery to repair the knee using NOVOSTITCH PRO. Images and videos inside the knee during surgery may be sent to the study.
Participants will be followed 2 years after surgery. There are a total of 5 follow-up visits: 2 weeks, 3 months, 6 months, 1 year, and 2 years after surgery. Data will be obtained from medical records, surveys, MRIs, and radiographs. Up to 30 participants will have an optional needle endoscopy at the 6-month follow-up visit.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOVOSTITCH™ PRO Meniscal Repair System | Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOVOSTITCH™ PRO Meniscal Repair System | Device | Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Freedom From Reoperation at 12 Months After Surgery | Percentage of participants with freedom from reoperation due to meniscal repair failure at 12 months after surgery (i.e., no re-operation required). Freedom from reoperation was defined as no re-operation required due to meniscal repair failure for any reason. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Freedom From Reoperation at 6 & 24 Months After Surgery | Percentage of participants with freedom from reoperation due to meniscal repair failure at 6 months & 24 months after surgery (i.e., no re-operation required). Freedom from reoperation was defined as no re-operation required due to meniscal repair failure for any reason. | 6 months, 24 months |
Not provided
Inclusion Criteria:
Subjects will be eligible for the study if they meet all of the following criteria at the Baseline Screening:
Consented subjects may be included in the study only if, upon arthroscopic inspection during the procedure, their meniscal study lesion meets all of the following criteria:
Meniscal tear amenable to repair with NOVOSTITCH PRO with or without the use of adjunct devices per the exclusion criteria;
Tear pattern is one of the following:
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of following criteria at the Baseline Screening:
Subjects will be excluded from the study if their study meniscus lesion meets any of the following criteria at arthroscopy:
Ramp tears;
Root or other tear type requiring tibial fixation;
Tears requiring repair of both meniscus in the study knee;
Intact or partially intact meniscus tear that, in the opinion of the Investigator, does not require repair;
Poor meniscal tissue quality such that it will not hold a suture;
For HCTs:
For complex tears:
a. Any portion of the meniscal tear is repaired using a device to place stitches other than NOVOSTITCH PRO, Meniscus Mender II, Meniscal Stitcher, FIRSTPASS MINI, FAST-FIX 360, or ULTRA FAST-FIX marketed by Smith + Nephew Inc.;
Clinically significant (zone 1 and/or zone 2) tear in the contralateral compartment to the study meniscus;
Performance of a significant concomitant procedure (e.g. ACL reconstruction or repair, cartilage repair or restoration) intended as a therapeutic intervention on the study knee;
Presence of infection;
Articular cartilage damage in the study knee, defined as Modified Outerbridge Grade III or higher.
Not provided
Not provided
Subjects will be recruited at the sports medicine/orthopedic clinic.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karlie Morgan, BS CCRP | Smith & Nephew, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAO Research Foundation | Washington D.C. | District of Columbia | 20037 | United States | ||
| Hawai'i Pacific Health / Straub Medical Center |
There were 2 participants enrolled in the study that were excluded from full analysis because the decision was made intraoperatively to not use the study device. These participants were considered screen failures due to intraoperative eligibility criteria and only included in safety adverse event reporting.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | NOVOSTITCH™ PRO Meniscal Repair System | Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Full Analysis Set (FAS) population included participants enrolled into the study that attended at least one post- surgery assessment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NOVOSTITCH™ PRO Meniscal Repair System | Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System |
| 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 | Rate of Freedom From Reoperation at 12 Months After Surgery | Percentage of participants with freedom from reoperation due to meniscal repair failure at 12 months after surgery (i.e., no re-operation required). Freedom from reoperation was defined as no re-operation required due to meniscal repair failure for any reason. | Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months |
|
Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NOVOSTITCH™ PRO Meniscal Repair System | Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| APNEA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated to device and procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HYPERSENSITIVITY/ALLERGIC REACTION | Immune system disorders | Systematic Assessment |
MRI is known to be suboptimal for meniscal healing assessment (DiBartola et al.).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Clinical Compliance | Smith+Nephew, Inc | 1-800-821-5700 | 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 | Apr 7, 2020 | Apr 15, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 28, 2024 | Apr 22, 2025 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
| Structural Integrity of Meniscus Assessed by MRI | Structural integrity of the meniscus was identified using Magnetic Resonance Imaging (MRI) by the results of the Meniscal Signal Index Meniscus grading. Participants were categorized using the following grading:
| Baseline, 12 months, and 24 months |
| Change in Tibiofemoral Joint Space Narrowing (JSN) in Medial Compartment From Baseline to 24 Months | Change in Tibiofemoral Joint Space Narrowing (JSN) in the medial compartment was measured in millimeters (mm) as assessed by x-rays. | Baseline to 24 months |
| Change in Tibiofemoral Joint Space Narrowing (JSN) in Lateral Compartment From Baseline to 24 Months | Change in Tibiofemoral Joint Space Narrowing (JSN) in the lateral compartment was measured in millimeters (mm) as assessed by x-rays. | Baseline to 24 months |
| In-Office Needle Endoscopy at 6 Months | In-office needle endoscopy is a minimally invasive procedure in which a needle-sized camera is inserted into tissue for observation and/or biopsy purposes. For this study, a needle-sized endoscopy was inserted to record video and images of the meniscal repair site and visually assess healing. Healing by participant was categorized as:
| 6 months |
| Patient Reported Outcome (PRO): International Knee Documentation Committee (IKDC) Subjective Score | The International Knee Documentation Committee (IKDC) Subjective score was developed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment, including patients with meniscal injuries. Possible scores range from 0-100, where 100 indicated the highest level of function and lowest level of symptoms (i.e., better outcome), and 0 indicated the lowest level of function or highest level of symptoms (i.e., worse outcome). | Baseline, 6 months, 12 months, and 24 months |
| Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms Score | The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items). A Likert scale is used for each subscale with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome). | Baseline, 6 months, 12 months, and 24 months |
| Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Score | The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items). A Likert scale is used for each subscale with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome). | Baseline, 6 months, 12 months, and 24 months |
| Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activities of Daily Life Score | The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items). A Likert scale is used for each subscale with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome). | Baseline, 6 months, 12 months, and 24 months |
| Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport Score | The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items). A Likert scale is used for each subscale with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome). | Baseline, 6 months, 12 months, and 24 months |
| Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life Score | The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items). A Likert scale is used for each subscale with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome). | Baseline, 6 months, 12 months, and 24 months |
| Patient Reported Outcome (PRO): Lysholm Knee Scoring Scale Score | The Lysholm Knee Scoring Scale measures the participant's symptoms and functioning of daily activities by assessing 8 items: limping, using cane or crutches, locking sensation in the knee, giving way sensation from the knee, pain, swelling, climbing stairs, and squatting. The scale is scored on a scale from 0 to 100, with a higher score indicating fewer symptoms and higher level of functioning (i.e., a better outcome). | Baseline, 6 months, 12 months, and 24 months |
| Honolulu |
| Hawaii |
| 96813 |
| United States |
| Rush University Medical Center / Midwest Orthopaedics at Rush | Chicago | Illinois | 60612 | United States |
| University of Kansas Medical Center | Overland Park | Kansas | 66211 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Ohio State University/Jameson Crane Sports Medicine Institute | Columbus | Ohio | 43202 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Tear Type | Count of Participants | Participants |
|
|
|
| Secondary | Rate of Freedom From Reoperation at 6 & 24 Months After Surgery | Percentage of participants with freedom from reoperation due to meniscal repair failure at 6 months & 24 months after surgery (i.e., no re-operation required). Freedom from reoperation was defined as no re-operation required due to meniscal repair failure for any reason. | Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months, 24 months |
|
|
|
| Secondary | Structural Integrity of Meniscus Assessed by MRI | Structural integrity of the meniscus was identified using Magnetic Resonance Imaging (MRI) by the results of the Meniscal Signal Index Meniscus grading. Participants were categorized using the following grading:
| Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified. | Posted | Count of Participants | Participants | Baseline, 12 months, and 24 months |
|
|
|
| Secondary | Change in Tibiofemoral Joint Space Narrowing (JSN) in Medial Compartment From Baseline to 24 Months | Change in Tibiofemoral Joint Space Narrowing (JSN) in the medial compartment was measured in millimeters (mm) as assessed by x-rays. | Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified. | Posted | Mean | Standard Deviation | millimeters (mm) | Baseline to 24 months |
|
|
|
| Secondary | Change in Tibiofemoral Joint Space Narrowing (JSN) in Lateral Compartment From Baseline to 24 Months | Change in Tibiofemoral Joint Space Narrowing (JSN) in the lateral compartment was measured in millimeters (mm) as assessed by x-rays. | Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified. | Posted | Mean | Standard Deviation | millimeters (mm) | Baseline to 24 months |
|
|
|
| Secondary | In-Office Needle Endoscopy at 6 Months | In-office needle endoscopy is a minimally invasive procedure in which a needle-sized camera is inserted into tissue for observation and/or biopsy purposes. For this study, a needle-sized endoscopy was inserted to record video and images of the meniscal repair site and visually assess healing. Healing by participant was categorized as:
| Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Patient Reported Outcome (PRO): International Knee Documentation Committee (IKDC) Subjective Score | The International Knee Documentation Committee (IKDC) Subjective score was developed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment, including patients with meniscal injuries. Possible scores range from 0-100, where 100 indicated the highest level of function and lowest level of symptoms (i.e., better outcome), and 0 indicated the lowest level of function or highest level of symptoms (i.e., worse outcome). | Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 12 months, and 24 months |
|
|
|
| Secondary | Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms Score | The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items). A Likert scale is used for each subscale with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome). | Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 12 months, and 24 months |
|
|
|
| Secondary | Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Score | The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items). A Likert scale is used for each subscale with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome). | Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 12 months, and 24 months |
|
|
|
| Secondary | Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activities of Daily Life Score | The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items). A Likert scale is used for each subscale with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome). | Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 12 months, and 24 months |
|
|
|
| Secondary | Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport Score | The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items). A Likert scale is used for each subscale with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome). | Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 12 months, and 24 months |
|
|
|
| Secondary | Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life Score | The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items). A Likert scale is used for each subscale with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome). | Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 12 months, and 24 months |
|
|
|
| Secondary | Patient Reported Outcome (PRO): Lysholm Knee Scoring Scale Score | The Lysholm Knee Scoring Scale measures the participant's symptoms and functioning of daily activities by assessing 8 items: limping, using cane or crutches, locking sensation in the knee, giving way sensation from the knee, pain, swelling, climbing stairs, and squatting. The scale is scored on a scale from 0 to 100, with a higher score indicating fewer symptoms and higher level of functioning (i.e., a better outcome). | Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 12 months, and 24 months |
|
|
|
| 0 |
| 33 |
| 6 |
| 33 |
| 18 |
| 33 |
|
| MENSTRUAL IRREGULARITIES | Reproductive system and breast disorders | Systematic Assessment | Unrelated to device and procedure |
|
| BONE FRACTURE(S) | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device and procedure |
|
| LIMB FRACTURE | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device and procedure |
|
| PAIN | General disorders | Systematic Assessment | Unrelated to device and procedure |
|
| UNSPECIFIED VASCULAR PROBLEM | Vascular disorders | Systematic Assessment |
|
| RESPIRATORY TRACT INFECTION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| UNSPECIFIED RESPIRATORY PROBLEM | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| CORNEAL ABRASION | Eye disorders | Systematic Assessment |
|
| UNSPECIFIED EAR OR LABYRINTH PROBLEM | Ear and labyrinth disorders | Systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | Systematic Assessment |
|
| UNSPECIFIED GASTROINTESTINAL PROBLEM | Gastrointestinal disorders | Systematic Assessment |
|
| VITAMIN DEFICIENCY | Endocrine disorders | Systematic Assessment |
|
| URINARY TRACT INFECTION | Renal and urinary disorders | Systematic Assessment |
|
| BREAST MASS | Reproductive system and breast disorders | Systematic Assessment |
|
| CONGENITAL DEFECT/DEFORMITY | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| ARTHRITIS | 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 WEAKNESS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| BURNING SENSATION | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| SKIN DISCOLORATION | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| SKIN DISORDERS | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | Systematic Assessment |
|
| BACTERIAL INFECTION | Infections and infestations | Systematic Assessment |
|
| TOXEMIA | Infections and infestations | Systematic Assessment |
|
| FUNGAL INFECTION | Infections and infestations | Systematic Assessment |
|
| DAMAGE TO LIGAMENT(S) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| BRUISE/CONTUSION | Injury, poisoning and procedural complications | Systematic Assessment |
|
| IMPLANT PAIN | General disorders | Systematic Assessment |
|
| HEADACHE | General disorders | Systematic Assessment |
|
| INFLAMMATION | General disorders | Systematic Assessment |
|
| PAIN | General disorders | Systematic Assessment |
|
| CHEST PAIN | 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.
|
| Grade 2 |
|
| Grade 3 |
|
| 12 months |
|
|
| 24 months |
|
|
|
| 12 months |
|
|
| 24 months |
|
|
|
| 12 months |
|
|
| 24 months |
|
|
|
| 12 months |
|
|
| 24 months |
|
|
|
| 12 months |
|
|
| 24 months |
|
|
|
| 12 months |
|
|
| 24 months |
|
|
|
| 12 months |
|
|
| 24 months |
|
|
|
| 12 months |
|
|
| 24 months |
|
|