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

Meniscus Tear Clinical Trial

— FAST-FIX FLEX  

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04903106
• Other study ID #: FAST-FIX FLEX.2020.09
• Status: Active, not recruiting
• Start date: January 20, 2022
• Est. completion date: May 25, 2025

Study information

• Verified date: December 2023
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 sample size for this study is determined based on the feasibility of recruitment, enrolment and follow-up considerations.

The primary endpoint upon which the sample size is determined is defined by the rate of reoperation after 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: May 25, 2025
• Est. primary completion date: May 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Meniscus Tear

Intervention

Device:
• FAST-FIX FLEX Meniscal Repair System
Standard of care surgery in which the meniscus is repaired using FAST-FIX FLEX 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.

Locations

Country	Name	City	State
Australia	Fremantle Hospital	Fremantle	Western Australia
France	Ambroise Paré Clinic	Paris	Neuilly-Sur-Seine
United Kingdom	Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust	Oswestry	Shropshire
United States	Rush University Medical Center	Chicago	Illinois
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Countries where clinical trial is conducted

United States,  Australia,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Success	Rate of reoperation due to meniscal repair failure at 12 months postoperative	12 months
Secondary	Clinical Success	Rate of reoperation due to meniscal repair failure at 6 months postoperative	6 months
Secondary	Clinical Success	Rate of reoperation due to meniscal allograft transplantation failure at 6 months & 12 months post-operative	6 months and 12 months
Secondary	Meniscal Healing	MRI to assess structural integrity and meniscal healing at 6 months and 12 months	Pre-operatively, 6 months and 12 months
Secondary	Change in 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. There are three domains: symptoms, including pain, stiffness, swelling, locking/catching, and giving way (7 items),; sports and daily activities (10 items), and; current knee function and knee function prior to knee injury (1 item, not included in the score).; Responses vary for each item. The possible score ranges from 0-100,where 100 = no limitation with daily or sporting activities and the absence of symptoms.	Pre-operatively, 6 months and 12 months
Secondary	Change in Patient Reported Outcome (PRO): Lysholm Score	This tool measures the domains of symptoms and complaints and functioning of daily activities. The scale consists of 8 items and is scaled from 0 to 100, with a higher score indicating fewer symptoms and higher level of functioning.	Pre-operatively, 6 months and 12 months
Secondary	Change in Patient Reported Outcome (PRO): EuroQol 5 Dimension 5 Level (EQ-5D-5L)	The EQ-5D-5L descriptive system comprises the following dimensions: Mobility, Self-Care, Usual Pain/ Discomfort and Anxiety/ Depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.	Pre-operatively, 6 months and 12 months