FibroFix Cartilage P Knee Implant Study

NCT05560490 | Terminated DMC

• 1 other identifier: ORTH CIP A001
• Study Type: interventional
• Target: 2
• Locations: 2 countries
• Sites: 2

Brief Summary

This is a multi-center first-in-human prospective clinical investigation to evaluate 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 aim is to 75 participants over two Stages: In STAGE I, up to a total of 6 subjects will be recruited and safety assessed after 6 months of follow-up. In Stage II an additional 69 subjects. The subjects will be followed up for 2 years with MRI imaging, then a further 8 years with patient outcome questionnaires.

Conditions

Osteoarthritis, Knee

Keywords

knee; cartilage repair; articular cartilage lesion; Cartilage implant

Outcome Measures

Primary Outcomes (2)

• Change in Knee injury and Osteoarthritis Outcome score (KOOS) - year 1(Pain and Sport/Rec only)

  The knee injury and Osteoarthritis Outcome Score is a patient-assessed outcome score. Questions use a 5-point Likert scale response. KOOS is scored into 5 subscales; Pain, other Symptoms, Activities of Daily Living (ADL) Sport and Recreation Function (Sport/Rec), and knee-related quality of life (QoL). Each subscale ranges from 0 indicating extreme symptoms to 100 indicating no symptoms. Subscale scores will be aggregated and averaged as a primary outcome. Change from baseline of 8 points in KOOS Pain scores and Function (Sport/Rec) scores at 1-year post-surgery.

  baseline (pre-surgery) to 1 year after surgery

• Safety endpoint - year 1

  Incidence of device related Adverse Events

  up to year 1 after surgery

Secondary Outcomes (52)

• Change in KOOS -week 6

  baseline (pre-surgery) to week 6 after surgery

• Change in KOOS -month 3

  baseline (pre-surgery) to month 3 after surgery

• Change in KOOS -month 6

  baseline (pre-surgery) to month 6 after surgery

• Change in KOOS -year 1

  baseline (pre-surgery) to year 1 after surgery

• Change in KOOS -year 2

  baseline (pre-surgery) to year 2 after surgery

Study Arms (1)

FibroFix Cartilage P Implant + Drill set

EXPERIMENTAL

Participants that have been implanted with FibroFix Cartilage P Implant using the FibroFix Drill Set

Device: FibroFix Cartilage P Knee Implantation

Interventions

FibroFix Cartilage P Knee Implantation DEVICE

The FibroFix Cartilage P instrument set (Drill set) is used for the preparation of an implant site and placement of the FibroFix Cartilage P Implant to resurface an articular cartilage lesion in the anterior and central regions of the femoral condyles of the knee.

FibroFix Cartilage P Implant + Drill set

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is able to provide written informed consent;
• Age ≥18 years at time of enrolment;
• Able to comply with the protocol-defined pre-operative procedures, the post-operative clinical and imaging evaluations and the recommended rehabilitation regimen as determined by the Investigator;
• Has a joint surface lesion, ICRS Grade 3 or above, on femoral condyles;
• Female subjects of child-bearing potential: a negative urine pregnancy test at time of enrolment.
• Patient has been diagnosed by MRI or other imaging technique to confirm presence of cartilage lesion and the lesion remains symptomatic. Only patients for whom the decision to perform surgery has already been made will be invited to participate. Asymptomatic lesions will NOT be included;
• Lesion area of less than of 26.6 mm height and less than 20.0 mm width in the index knee after debridement.

You may not qualify if:

• Age \>65 years or \<18 years at time of enrolment;
• Body Mass Index (BMI) \> 35;
• Lesion area of more than 26.6 mm length and more than 20.0 mm width in the index knee after debridement;
• Patient has multiple lesions to be treated;
• Articular cartilage lesions in the tibia or patella, ICRS grades 3 and above;
• KOOS Pain Subscale score at baseline that is \< 20 or \> 65. (Scale range: Maximum pain = 0, pain free = 100);
• Patient has previously received the FibroFix™ Cartilage P implant;
• Patient suffers from any medical condition that would hinder cartilage repair, such as additional unresolved comorbidities related to the index knee;
• Clinically significant untreated ligament instability of the same knee,
• Patient is post op from surgery on the same knee within 6 months which stipulates on-going rehabilitation,
• Untreated, symptomatic, unstable meniscal lesions on patients with residual meniscus volume of \<50% in the same compartment,
• Joint malalignment that in the opinion of the treating surgeon, requires osteotomy to correct,
• Any previous surgical cartilage treatment in the index knee within the previous 6 months,
• Evidence of osteonecrosis of the involved knee.
• A known allergy to:

Sponsors & Collaborators

• Orthox Limited: lead
• Avania B.V.: collaborator

Study Sites (2)

Menta Egészségközpont

Budapest, 1126, Hungary

Location

North Bristol NHS Trust

Bristol, BS10 5NB, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Michael Whitehouse

  North Bristol NHS HospitalsTrust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multicentre, prospective, non-randomised, open-label, first-in-human

Study Record Dates

• First Submitted: September 18, 2022
• First Posted: September 29, 2022
• Study Start: October 20, 2022
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

GB (1); HU (1)