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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04903106




Registration number
NCT04903106
Ethics application status
Date submitted
19/05/2021
Date registered
26/05/2021

Titles & IDs
Public title
Safety and Performance Study of the FAST-FIX FLEX System for Meniscal Repairs and Meniscal Transplantations
Scientific 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)
Secondary ID [1] 0 0
FAST-FIX FLEX.2020.09
Universal Trial Number (UTN)
Trial acronym
FAST-FIX FLEX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meniscus Tear 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - FAST-FIX FLEX Meniscal Repair System
Treatment: Devices - FAST-FIX FLEX Meniscal Repair System

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.

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.


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

Treatment: Devices: FAST-FIX FLEX Meniscal Repair System
Standard of care surgery in which the FASTFIX FLEX device is used during the meniscal allograft transplantation procedure.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Success
Assessment method [1] 0 0
Rate of reoperation due to meniscal repair failure at 12 months postoperative
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Clinical Success
Assessment method [1] 0 0
Rate of reoperation due to meniscal repair failure at 6 months postoperative
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Clinical Success
Assessment method [2] 0 0
Rate of reoperation due to meniscal allograft transplantation failure at 6 months \& 12 months post-operative
Timepoint [2] 0 0
6 months and 12 months
Secondary outcome [3] 0 0
Meniscal Healing
Assessment method [3] 0 0
MRI to assess structural integrity and meniscal healing at 6 months and 12 months
Timepoint [3] 0 0
Pre-operatively, 6 months and 12 months
Secondary outcome [4] 0 0
Change in Patient Reported Outcome (PRO): International Knee Documentation Committee (IKDC) Subjective Score
Assessment method [4] 0 0
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: 1. symptoms, including pain, stiffness, swelling, locking/catching, and giving way (7 items), 2. sports and daily activities (10 items), and 3. 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.
Timepoint [4] 0 0
Pre-operatively, 6 months and 12 months
Secondary outcome [5] 0 0
Change in Patient Reported Outcome (PRO): Lysholm Score
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Pre-operatively, 6 months and 12 months
Secondary outcome [6] 0 0
Change in Patient Reported Outcome (PRO): EuroQol 5 Dimension 5 Level (EQ-5D-5L)
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Pre-operatively, 6 months and 12 months

Eligibility
Key inclusion criteria
Meniscal Repair

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

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
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/11/2024
Sample size
Target
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
France
State/province [3] 0 0
Neuilly-Sur-Seine
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Shropshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Smith & Nephew, Inc.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Rupali Soeters
Address 0 0
Smith & Nephew, Inc.
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04903106