First-in-human study for the 'FibroFix Cartilage P™' knee implant

Not Applicable

• Conditions: Repair of articular cartilage lesion in the knee; Musculoskeletal Diseases

• Registration Number: ISRCTN13615940
• Lead Sponsor: Orthox (United Kingdom)

Brief Summary

2024 Funder report results see attached file ISRCTN13615940_FunderReport_13Sep24.pdf (added 16/09/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Last Update Posted: 26 August 2024
• Study Completion: 2034-08-31

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

1. Patient is able to provide written informed consent
2. Age =18 years at the time of enrolment
3. 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
4. Has a joint surface lesion, International Cartilage Repair Society (ICRS) Grade 3 or above, on femoral condyles
5. Female subjects of child-bearing potential: a negative urine pregnancy test at the time of enrolment
6. Patient has been diagnosed by MRI or other imaging technique to confirm the presence of a cartilage lesion and the lesion remains symptomatic. Only patients for whom the decision to perform the surgery has already been made will be invited to participate. Asymptomatic lesions will NOT be included.

Intra-operative inclusion criterion:
7. Lesion area of less than 26.6 mm in height and less than 20.0 mm in width in the index knee after debridement

Exclusion Criteria

1. Age >65 years or <18 years at the time of enrolment
2. Body mass index (BMI) >35 kg/m²
3. Lesion area of more than 26.6 mm length and more than 20.0 mm width in the index knee after debridement
4. Patient has multiple lesions to be treated
5. Articular cartilage lesions in the tibia or patella, ICRS grades 3 and above
6. KOOS Pain Subscale score at baseline that is <20 or >65 (scale range: maximum pain = 0, pain free = 100)
7. Patient has previously received the FibroFix™ Cartilage P implant
8. Patient suffers from any medical condition that would hinder cartilage repair, such as additional unresolved comorbidities related to the index knee
8.1. Clinically significant untreated ligament instability of the same knee
8.2. Patient is post-op from surgery on the same knee within 6 months which stipulates ongoing rehabilitation
8.3. Untreated, symptomatic, unstable meniscal lesions on patients with residual meniscus volume of <50% in the same compartment
8.4. Joint malalignment that in the opinion of the treating surgeon, requires osteotomy to correct
8.5. Any previous surgical cartilage treatment in the index knee within the previous 6 months
8.6. Evidence of osteonecrosis of the involved knee
9. A known allergy to:
9.1. General and/or regional anaesthetic
9.2.. Silk or silk-containing products, or
9.3. Glycerol or products containing glycerol
10. Demonstrating an active local or systemic infection
11. Any condition, which in the judgment of the Investigator would preclude adequate evaluation of the FibroFix™ Cartilage P implant and clinical outcome
12. A history of confirmed anaphylactoid reaction
13. Has received local administration of any type of corticosteroid or systemic administration of antineoplastic, immunostimulating, or immunosuppressive agents within 180 days prior to the scheduled surgery
14. Medical history that includes a confirmed diagnosis of rheumatoid or inflammatory arthritis, or relapsing polychondritis
15. If female and of child-bearing potential: evidence of a positive pregnancy test or a stated intention to become pregnant in the next 6 months at the time of enrolment
16. Currently participating in another device or drug clinical investigation or has done so in the previous 3 months which would impact the results of the surgery in the opinion of the surgeon or be a barrier to participation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Incidence, nature, and severity of the procedure and/or device-related adverse events at 3- and 6-month post-surgery follow-up2. Knee functionality measured using KOOS Pain and Function (Sport/Rec) score at baseline and 1-year post-surgery follow-up