Trial Outcomes & Findings for Safety and Performance Study of the FAST-FIX FLEX System for Meniscal Repairs and Meniscal Transplantations (NCT NCT04903106)

Safety and Performance Study of the FAST-FIX FLEX System for Meniscal Repairs and Meniscal Transplantations

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.

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.

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.

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

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

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).

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).

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).

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.