Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects

NCT02423629 | Completed

• 1 other identifier: CLN0019
• Study Type: interventional
• Target: 143
• Locations: 8 countries
• Sites: 8

Brief Summary

Evaluate the performance of the Agili-C™ in the repair of Cartilage and Osteochondral defects.

Conditions

Cartilage or Osteochondral Defects in the Knee

Outcome Measures

Primary Outcomes (1)

• • The KOOS Pain Subscale relative to baseline

  The KOOS pain subscale is evaluated at 6m, 12m, 18m \& 24m

  24 Months

Secondary Outcomes (8)

• • Improvement in other KOOS subscales relative to baseline

  24 Months

• • Improvement in IKDC Subjective Knee Score relative to baseline

  24 Months

• • Improvement in SF-36 Survey

  24 Months

• • Improvement in Tegner Score

  24 Months

• • Improvement in Lysholm Knee Scoring Scale

  24 Months

Study Arms (1)

Agili C™

OTHER

Candidates will be screened for possible inclusion in the trial. Candidates that are approved by the adjudication committee will be considered for study enrollment and then operated. Note: in case intra-operatively a medical condition is observed which is not aligned with the inclusion/exclusion criteria, the Subject will not be implanted with the Agili-C™ device and will not be considered enrolled in the study.

Device: Agili-C™ implantation procedure

Interventions

Agili-C™ implantation procedure DEVICE

Candidates for Agili-C™ implantation will be screened for possible inclusion in the trial. Candidates that are approved by the adjudication committee will be considered for study enrollment and then operated. Note: in case intra-operatively a medical condition is observed which is not aligned with the inclusion/exclusion criteria, the Subject will not be implanted with the Agili-C™ device and will not be considered enrolled in the study.

Agili C™

Eligibility Criteria

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

You may qualify if:

• years or older
• Up to 3 treatable cartilage lesions, ICRS IIIa - IVb on the femoral condyles or the trochlea,
• Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation
• KOOS Pain score at baseline is not less than 30 and not more than 65
• Must be physically and mentally willing and able to comply with post- operative rehabilitation protocol and scheduled clinical and radiographic visits.
• Informed consent signing

You may not qualify if:

• Bony defect depth deeper than 8mm, according to imaging Articular cartilage lesions in the tibia or the patella, ICRS grades IVa and IVb
• Any previous ligamentous repair or malalignment correction in the index knee within the last 3 months
• Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal)
• Lack of functional remaining meniscus
• Meniscal transplantation in the past 6 months
• Malalignment more than 5 degrees varus OR 5 degrees valgus according to standing X-ray
• Any known tumor of the index knee
• Any know history of infection of the index knee
• Any known history of inflammatory arthropathy or crystal-deposition arthropathy
• Any known systemic cartilage and/or bone disorder such as but not limited to chondrodysplasia or osteogenesis imperfecta
• Body mass index \>35
• Osteoarthritis of the index knee graded as 4 according to the Kellgren- Lawrence scale
• Chemotherapy treatment in the past 12 months
• Any previous surgical cartilage treatment in the index knee within the last 6 months
• History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (8)

Medical University of Vienna

Vienna, Austria

Location

AZ Monica

Antwerp, Belgium

Location

Hasharon medical center

Petah Tikva, Israel

Location

Rizzoli Orthopaedic Institute

Bologna, Italy

Location

Specialist Hospital. Louis Rydygier

Krakow, Poland

Location

Timişoara County Hospital

Timișoara, Romania

Location

Institut za Ortopedsko-hirurške Bolesti "banjica"

Belgrade, Serbia

Location

University Medical Centre Ljubljana

Ljubljana, Slovenia

Location

Study Officials

• Elizaveta Kon, MD

  Rizzoli Institute, Bologna , Italy

  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

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: April 22, 2015
• Study Start: May 1, 2014
• Primary Completion: November 19, 2019
• Study Completion: November 19, 2019
• Last Updated: March 6, 2025

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); SL (1); PL (1); BE (1); IT (1); RO (1); SE (1); IL (1)