FFLEX Study (ORTH CIP A001)
Research type
Research Study
Full title
Safety and Performance of FibroFix Cartilage P Implant and Drill Set for Articular Cartilage Repair within the Knee Joint
IRAS ID
295616
Contact name
M Whitehouse
Contact email
Sponsor organisation
Orthox Limited
ISRCTN Number
ISRCTN13615940
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
Research Summary
This is a clinical investigation on the safety and performance of the FibroFix™ Cartilage P Implant and Drill Set. The Implant is a medical device designed by Orthox Ltd. to repair a damaged area of cartilage within the knee joint. The Implant is made from a protein extracted from silk fibres to give it the necessary strength and flexibility to replace the structure and function of the cartilage. It has a porous structure which acts as a scaffold, allowing cells to move through the structure and produce new cartilage-like tissue. The cartilage repair is performed using the specially developed Drill Set intended for the removal of tissue for preparation of the implant site. Both the Implant and Drill Set have not been implanted/used in/on humans before.
The study will be conducted at several hospitals in the UK and Europe.
In Stage I, up to a total of 6 subjects (who have been implanted with the FibroFix Cartilage P) will be enrolled, to provide a minimum of 5 evaluable subjects. After 3M and 6M post-surgery a safety evaluation will occur by an independent Data Monitoring Committee. After authorization by the DMC, Stage II will be open to enroll an additional 69 subjects (who have been implanted with the FibroFix Cartilage P), to provide a total of 75 subjects who have been implanted with the FibroFix Cartilage P (and provide a total of 60 evaluable subjects).
After a screening visit and the surgery, subjects will be seen for 6 follow up visits over a period of 2 years. Subjects will be asked to complete several questionnaires and to undergo an MRI at 4 timepoints.Summary of Results
Two subjects, 1-01 and 1-02, were recruited in the UK (Site 01), who had FibroFix™ Cartilage P implanted on 2 Dec 2022 and 27 Jan 2023, respectively. Both were followed up to their 3-month post-surgery follow-up and adhered to their rehabilitation regime throughout their post-surgical follow-up. Both did not complete the study and both were withdrawn on 5 May 2023 due to Serious Adverse Events (SAE) which were followed up until 10th Jan 2024 at which point they were considered to be stabilised and were closed with sequelae.
Baseline and follow-up clinical and questionnaire-based outcome assessments were collected from both subjects and usability questionnaires were collected from each user group after each surgery; however, statistical analysis could not be performed due to the low recruitment and short follow up duration.
Device Deficiencies:
Two Device Deficiencies (DD), both involving FibroFix™ Cartilage P Drill Set, occurred in total (one deficiency during each surgery), which did not cause any surgical problems and were not associated with any patient Adverse Events (AE)
Adverse Events:
Subject 1-01 experienced a post-surgery swelling at the index knee that did not resolve. This became a Serious Adverse Event (SAE) at 3 months post-surgery and required an Examination Under Anaesthetic (EUA), and an Aspiration procedure to be performed. The SAE did not resolve after a subsequent 2 week course of oral steroids and required reoperation to remove the implant. The patient was then withdrawn from the study.
Subject 1-02 experienced synovitis, inflammation and more pain than expected at 3 months post-surgery. A Magnetic Resonance Image (MRI) was taken and raised concerns consistent with SAE symptom progression. The Investigator conducted a reoperation to remove the implant and the patient was withdrawn from the study.
As a result of the implant removal from the first two patients recruitment was halted. After consultation involving the Data Monitoring Committee, the Sponsor made the decision to terminate the study.
Endpoint analysis related to study objectives:
As only two Subjects were recruited, and both were withdrawn due to SAEs related to the FibroFix™ Cartilage P implant, the Primary Objective and all Secondary Objectives have not been met for FibroFix™ Cartilage P implant.
With only two uses, data collected is considered insufficient to to demonstrate safety and performance of the FibroFix™ Cartilage P Drill Set.
The FibroFix™ Cartilage P implant and the FibroFix™ Cartilage P Drill Set has failed to demonstrate safety and performance for their intended purpose.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
21/WM/0280
Date of REC Opinion
1 Feb 2022
REC opinion
Further Information Favourable Opinion