Meniscus Tear
Conditions
Keywords
FAST-FIX FLEX, meniscal, meniscus, knee repair, meniscal allograft transplant, all-inside meniscal repair, FASTFIX
Brief summary
This study is a post-market follow-up study (PMCF). The data collected will serve the purpose of confirming the safety and performance of the FAST-FIX FLEX device, used according to the indicated for use (IFU) for meniscal repair and meniscal transplantations. Data will be collected on patients prior to surgery, at surgery and for 12 months after surgery.
Detailed description
This PMCF study is to satisfy the post-market surveillance obligations to the European Medical Device Regulation (EU MDR 2017/745). The data collected will serve the purpose of confirming the safety and performance of the FAST-FIX FLEX device, used according to the indicated for use (IFU) for meniscal repair and meniscal transplantations. Data will be collected on patients prior to surgery, at surgery and for 12 months after surgery. The objectives of the study are to assess the clinical success rate of both clinical indications (meniscal repair and meniscal allograft transplantations) and the performance and safety of the FAST-FIX FLEX meniscal repair system. The sample size for this study is precision-based, and not based on statistical power considerations, thus no formal statistical hypothesis is formulated. The primary endpoint for the study upon which sample size is determined is meniscal repair success rate in the study device at 12 months. Additionally, secondary endpoints in this study assess success rate, meniscus healing and clinical performance of Patient Reported Outcomes (PRO) for meniscal repair and meniscal allograft transplantations.
Interventions
DEVICEFAST-FIX FLEX Meniscal Repair System
Standard of care surgery in which the meniscus is repaired using FAST-FIX FLEX device.
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Meniscal Repair Inclusion Criteria: 1. Subject provides written informed consent for study participation using an independent ethical committee (IEC) / institutional review board (IRB) approved consent form; 2. Subject is between sixteen (16) and seventy (70) years of age, inclusive at the time of screening; 3. Subject is willing and able to participate in required follow-up visits and is able to complete study activities; 4. Subject requires a meniscal repair; 5. Subject is suitable to participate in the study in the opinion of the Investigator; 6. Subject requires a meniscus repair concerning the red-red or red-white zones for acute or chronic 1-, 2- or 3-segment lesions, with or without associated anterior cruciate ligament (ACL) reconstruction. Meniscal Allograft Transplantation Inclusion Criteria: 1. Subject provides written informed consent for study participation using an independent ethical committee (IEC) / institutional review board (IRB) approved consent form; 2. Subject is between sixteen (16) and seventy (70) years of age, inclusive at the time of screening; 3. Subject is willing and able to participate in required follow-up visits and is able to complete study activities; 4. Subject requires a meniscal allograft transplantation; 5. Subject is suitable to participate in the study in the opinion of the Investigator. 6. Subject requires a MAT for symptomatic meniscal insufficiency (load-related pain and swelling in the compartment post meniscectomy) for which conservative treatment has failed, with or without cartilage repair or restoration (including ACL reconstruction or repair). Meniscal Repair
Exclusion criteria
1. Contraindications (per the FAST-FIX FLEX IFU) or hypersensitivity to the use of the FAST-FIX FLEX implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation; 2. Enrolled in the treatment period of another clinical trial within thirty (30) days of operative visit, or during the study; 3. Women who are pregnant or nursing; 4. Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55 (except for subjects aged sixteen (16) or seventeen (17) years of age with consent from their legally authorized representative); 5. Subjects with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation; 6. Patients with irreparable meniscal tears (i.e. multiple tears); 7. Subjects with full thickness cartilage defects greater than 10mm in diameter and/or serious defects; 8. Patients with concomitant ligament injuries that do not require surgical repair (i.e. ACL with Grade 3 lateral collateral ligament (LCL) injury or medial collateral ligament (MCL) injury); 9. Performance of a significant concomitant procedure, specifically a cartilage repair or restoration (excluding ACL reconstruction or repair, lateral extra-articular tenodesis, anterolateral ligament (ALL) reconstruction) intended as a therapeutic intervention on the study knee; 10. History of ipsilateral knee surgery, septic joint, or fracture; 11. Pathological conditions in the soft tissue that would prevent secure fixation of the device; 12. Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing; 13. The presence of infection; 14. Conditions which would limit the patient's ability or willingness to restrict activities or follow directions during the healing period; 15. Malalignment: genu varus and genu valgus angles greater than 5° as evaluated by the patient's physician as per their standard of care; 16. Patients who have an Ahlback grade greater than II; 17. Patients with a body mass index larger than 35; 18. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study. Meniscal Allograft Transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reoperations at 12 Months | 12 months | Count of participants with reoperations due to meniscal repair failure at 12 months postoperative. Failure was defined as revision surgery at the primary site of the tear. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reoperations at 6 Months | 6 months | Count of participants with reoperations due to meniscal repair failure at 6 months postoperative. Failure was defined as revision surgery at the primary site of the tear. |
| Reoperations From Month 6 to Month 12 | Month 6 to Month 12, approximately 6 months | Count of participants with reoperations due to meniscal repair failure during the period starting from Month 6 postoperatively (227 days after surgery) to Month 12 postoperatively. Failure was defined as a revision of the transplantation and/or removal of the allograft. |
| Meniscal Healing by Meniscal Repair Status Grading | 6 months and 12 months | MRI to assess number of participants with structural integrity and meniscal healing at 6 months and 12 months was derived by the meniscal repair status according to one the following categories: * Grade 0 - Low signal intensity at the site of original tear(s). * Grade 1 - Irregularly marginated, elevated signal with globular shape, at the site of original tear(s). * Grade 2 - Linear elevated signal (i.e. confirmed fluid signal) at the site of original tear(s), not extending into the tibial or femoral articular surface. * Grade 3 - Linear elevated signal (i.e. confirmed fluid signal) at the site of original tear(s), extending into the tibial or femoral articular surface, suggestive of a re-tear. * UA - Unable to Assess * NR - Not Required |
| Meniscal Healing by Meniscal Transplant Status Grading | 6 months and 12 months | MRI to assess number of participants with structural integrity and meniscal healing at 6 months and 12 months for meniscal transplant status was derived from relative percentage of extrusion (RPE) recorded on the coronal plane and sagittal plane using the following categories: * Grade 0 - RPE \< 50% on both sagittal and coronal planes, i.e. RPE (Radial) \< 50% AND \[RPE (Anterior) \< 50% AND RPE (Posterior) \< 50%\]. * Grade 1 - RPE ≥ 50% on only one plane, i.e. RPE (Radial) ≥ 50% OR \[RPE (Anterior) ≥ 50% OR RPE (Posterior) ≥ 50%\]. * Grade 2 - RPE ≥ 50% on both sagittal and coronal planes, i.e. RPE (Radial) ≥ 50% AND \[RPE (Anterior) ≥ 50% OR RPE (Posterior) ≥ 50%\]. * NR - Not Required |
| Patient Reported Outcome (PRO): International Knee Documentation Committee (IKDC) Subjective Score | Pre-operatively, 6 months and 12 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): Lysholm Score | Pre-operatively, 6 months and 12 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 scores are on a scale from 0 to 100, with a higher score indicating fewer symptoms and a higher level of functioning (i.e., a better outcome). |
| Patient Reported Outcome (PRO): EuroQol 5 Dimension 5 Level (EQ-5D-5L): Visal Analogue Scale (VAS) Score | Pre-operatively, 6 months and 12 months | The EQ-5D-5L is composed of the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The EQ VAS score is 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). |
| Patient Reported Outcome (PRO): EuroQol 5 Dimension 5 Level (EQ-5D-5L): Health Score | Pre-operatively, 6 months and 12 months | The EQ-5D-5L is composed of the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) to create a combined Health Score. The combined Health Score is on a scale of 0 to 1 with a higher score indicating a better outcome. |
Countries
Australia, France, United Kingdom, United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 32.0 years STANDARD_DEVIATION 11.5 |
| Body Mass Index (BMI) | 24.9 kg/m^2 STANDARD_DEVIATION 3.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 10 |
| other Total, other adverse events | 16 / 53 | 3 / 10 |
| serious Total, serious adverse events | 7 / 53 | 2 / 10 |
Outcome results
None listed