Meniscus Tear, Retention; Meniscus
Conditions
Keywords
NOVOSTITCH, meniscal, meniscus, repair, knee, horizontal cleavage, complex tear, arthroscopy
Brief summary
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.
Detailed description
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.
Interventions
DEVICENOVOSTITCH™ PRO Meniscal Repair System
Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subjects will be eligible for the study if they meet all of the following criteria at the Baseline Screening: 1. Able and willing to give informed consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board; 2. 18 to 70 years of age, inclusive at the time of screening; 3. History indicative of meniscal pathology (e.g., pain, mechanical symptoms described as locking, clicking or giving way); 4. Physical exam consistent with meniscus tear (e.g., locked joint, joint line tenderness and/or pain on meniscal compression); 5. If prior ligament reconstruction, the study knee is clinically stable; 6. Meniscal repair to be performed arthroscopically; 7. Preoperative MRI evidence consistent with a horizontal cleavage or complex meniscus tear in the symptomatic compartment; 8. Willing and able to comply with all study procedures and visit requirements, including MRIs, X-rays, and Case Report Forms (CRFs) completed by the subject. * 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: 1. Meniscal tear amenable to repair with NOVOSTITCH PRO with or without the use of adjunct devices per the
Exclusion criteria
; 2. Tear pattern is one of the following: 1. Horizontal cleavage tear (HCT), or 2. Complex multi-planar tear (combination of at least two of the following tears: horizontal, oblique, radial, vertical).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Freedom From Reoperation at 12 Months After Surgery | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Freedom From Reoperation at 6 & 24 Months After Surgery | 6 months, 24 months | 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. |
| Structural Integrity of Meniscus Assessed by MRI | Baseline, 12 months, and 24 months | 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: * Grade 0: Low signal intensity indicative of a normal meniscus. * Grade 1: Irregularly marginated elevated signal with globular shape, suggestive of early meniscal degeneration. * Grade 2: Linear elevated signal (i.e. confirmed fluid signal) not extending into the tibial or femoral articular surface. * Grade 3: Linear elevated signal (i.e. confirmed fluid signal) extending into the tibial or femoral articular surface, suggestive of a tear |
| Change in Tibiofemoral Joint Space Narrowing (JSN) in Medial Compartment From Baseline to 24 Months | 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. |
| Change in Tibiofemoral Joint Space Narrowing (JSN) in Lateral Compartment From Baseline to 24 Months | 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. |
| In-Office Needle Endoscopy at 6 Months | 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: * Healed * Incompletely Healed * Failure |
| Patient Reported Outcome (PRO): International Knee Documentation Committee (IKDC) Subjective Score | Baseline, 6 months, 12 months, and 24 months | 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). |
| Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms Score | Baseline, 6 months, 12 months, and 24 months | 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). |
| Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Score | Baseline, 6 months, 12 months, and 24 months | 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). |
| Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activities of Daily Life Score | Baseline, 6 months, 12 months, and 24 months | 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). |
| Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport Score | Baseline, 6 months, 12 months, and 24 months | 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). |
| Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life Score | Baseline, 6 months, 12 months, and 24 months | 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). |
| Patient Reported Outcome (PRO): Lysholm Knee Scoring Scale Score | Baseline, 6 months, 12 months, and 24 months | 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). |
Countries
United States
Contacts
STUDY_CHAIRKarlie Morgan, BS CCRP
Smith & Nephew, Inc.
Participant flow
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 48.0 years STANDARD_DEVIATION 10.9 |
| Body Mass Index (BMI) | 27.6 kg/m^2 STANDARD_DEVIATION 4.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 26 Participants |
| Tear Type Complex multi-planar tear | 25 Participants |
| Tear Type Horizontal cleavage meniscal tear | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 18 / 33 |
| serious Total, serious adverse events | 6 / 33 |
Outcome results
None listed