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

NCT04903106 | Completed Results FDA Device

• 1 other identifier: FAST-FIX FLEX.2020.09
• Study Type: observational
• Target: 63
• Locations: 4 countries
• Sites: 5

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.

Conditions

Meniscus Tear

Keywords

FAST-FIX FLEX; meniscal; meniscus; knee repair; meniscal allograft transplant; all-inside meniscal repair; FASTFIX

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Reoperations at 6 Months

  6 months

• Reoperations From Month 6 to Month 12

  Month 6 to Month 12, approximately 6 months

• Meniscal Healing by Meniscal Repair Status Grading

  6 months and 12 months

• Meniscal Healing by Meniscal Transplant Status Grading

  6 months and 12 months

• Patient Reported Outcome (PRO): International Knee Documentation Committee (IKDC) Subjective Score

  Pre-operatively, 6 months and 12 months

Study Arms (2)

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

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

Interventions

FAST-FIX FLEX Meniscal Repair System DEVICE

Standard of care surgery in which the meniscus is repaired using FAST-FIX FLEX device.

Meniscal Tear

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who require a meniscal repair or meniscal allograft transplantation.

You may qualify if:

• Subject provides written informed consent for study participation using an independent ethical committee (IEC) / institutional review board (IRB) approved consent form;
• Subject is between sixteen (16) and seventy (70) years of age, inclusive at the time of screening;
• Subject is willing and able to participate in required follow-up visits and is able to complete study activities;
• Subject requires a meniscal repair;
• Subject is suitable to participate in the study in the opinion of the Investigator;
• 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.
• Subject provides written informed consent for study participation using an independent ethical committee (IEC) / institutional review board (IRB) approved consent form;
• Subject is between sixteen (16) and seventy (70) years of age, inclusive at the time of screening;
• Subject is willing and able to participate in required follow-up visits and is able to complete study activities;
• Subject requires a meniscal allograft transplantation;
• Subject is suitable to participate in the study in the opinion of the Investigator.
• 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).

You may not qualify if:

• 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;
• Enrolled in the treatment period of another clinical trial within thirty (30) days of operative visit, or during the study;
• Women who are pregnant or nursing;
• 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);
• Subjects with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation;
• Patients with irreparable meniscal tears (i.e. multiple tears);
• Subjects with full thickness cartilage defects greater than 10mm in diameter and/or serious defects;
• 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);
• 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;
• History of ipsilateral knee surgery, septic joint, or fracture;
• Pathological conditions in the soft tissue that would prevent secure fixation of the device;
• Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing;
• The presence of infection;
• Conditions which would limit the patient's ability or willingness to restrict activities or follow directions during the healing period;
• Malalignment: genu varus and genu valgus angles greater than 5° as evaluated by the patient's physician as per their standard of care;

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (5)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Fremantle Hospital

Fremantle, Western Australia, 6160, Australia

Location

Ambroise Paré Clinic

Paris, Neuilly-Sur-Seine, 92200, France

Location

Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, Shropshire, SY10 7AG, United Kingdom

Location

Limitations and Caveats

MRI is known to be suboptimal for meniscal healing assessment (DiBartola et al.).

Results Point of Contact

• Title: Senior Manager Clinical Compliance
• Organization: Smith+Nephew, Inc

datasharing.gcs@smith-nephew.com

1-800-821-5700

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 26, 2021
• Study Start: January 20, 2022
• Primary Completion: November 26, 2024
• Study Completion: November 26, 2024
• Last Updated: March 18, 2026
• Results First Posted: March 18, 2026

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); US (2); FR (1); AU (1)