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

A Prospective, Multi-center Clinical Study to Evaluate the Safety and Performance of the FAST-FIX FLEX System for Meniscal Repairs (MR) and Meniscal Allograft Transplantations (MAT)

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.

Study Overview

• Status: Completed
• Conditions: Meniscus Tear
• Intervention / Treatment: Device: FAST-FIX FLEX Meniscal Repair System; Device: FAST-FIX FLEX Meniscal Repair System

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.

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Fremantle Hospital
• France
  • Neuilly-Sur-Seine
    • Paris, Neuilly-Sur-Seine, France, 92200
      • Ambroise Paré Clinic
• United Kingdom
  • Shropshire
    • Oswestry, Shropshire, United Kingdom, SY10 7AG
      • Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • New York
    • New York, New York, United States, 10021
      • Hospital For Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who require a meniscal repair or meniscal allograft transplantation.

Description

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 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 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);
7. Performance of a significant concomitant procedure (excluding ACL reconstruction or repair, lateral extra-articular tenodesis, anterolateral ligament (ALL) reconstruction) intended as a therapeutic intervention on the study knee;
8. History of ipsilateral knee surgery, septic joint, or fracture (excluding MAT indication);
9. Pathological conditions in the soft tissue that would prevent secure fixation of the device;
10. Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing;
11. The presence of infection;
12. Conditions which would limit the patient's ability or willingness to restrict activities or follow directions during the healing period;
13. Malalignment: genu varus and genu valgus angles greater than 5° as evaluated by the patient's physician as per their standard of care;
14. Patients who have an Ahlback grade greater than II;
15. Patients with a body mass index larger than 35;
16. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Meniscal Tear; 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.	Device: FAST-FIX FLEX Meniscal Repair System; Standard of care surgery in which the meniscus is repaired using FAST-FIX FLEX device.; Device: FAST-FIX FLEX Meniscal Repair System; Standard of care surgery in which the FASTFIX FLEX device is used during the meniscal allograft transplantation procedure.
Meniscal Insufficiency; Subject requires a MAT for symptomatic meniscal insufficiency (load related pain and swelling in the compartment undergoing meniscectomy) for which conservative treatment has failed, with or without cartilage repair or restoration (including ACL reconstruction or repair).	Device: FAST-FIX FLEX Meniscal Repair System; Standard of care surgery in which the meniscus is repaired using FAST-FIX FLEX device.; Device: FAST-FIX FLEX Meniscal Repair System; Standard of care surgery in which the FASTFIX FLEX device is used during the meniscal allograft transplantation procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reoperations at 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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reoperations at 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.	6 months
Reoperations From Month 6 to Month 12	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.	Month 6 to Month 12, approximately 6 months
Meniscal Healing by Meniscal Repair Status Grading	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	6 months and 12 months
Meniscal Healing by Meniscal Transplant Status Grading	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	6 months and 12 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).	Pre-operatively, 6 months and 12 months
Patient Reported Outcome (PRO): Lysholm 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 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).	Pre-operatively, 6 months and 12 months
Patient Reported Outcome (PRO): EuroQol 5 Dimension 5 Level (EQ-5D-5L): Visal Analogue Scale (VAS) Score	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).	Pre-operatively, 6 months and 12 months
Patient Reported Outcome (PRO): EuroQol 5 Dimension 5 Level (EQ-5D-5L): Health Score	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.	Pre-operatively, 6 months and 12 months

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Chair: Rupali Soeters, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): November 26, 2024
• Study Completion (Actual): November 26, 2024

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: meniscus; FAST-FIX FLEX; meniscal; knee repair; meniscal allograft transplant; all-inside meniscal repair; FASTFIX
• Other Study ID Numbers: FAST-FIX FLEX.2020.09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes