Agili-C™ Implant Performance Evaluation

NCT03299959 | Completed Results FDA Device

• 1 other identifier: CLN0021
• Study Type: interventional
• Target: 251
• Locations: 8 countries
• Sites: 26

Brief Summary

The current study compares the efficacy and safety of the Agili-C implant to Surgical Standard of Care treatment in patients suffering from joint surface lesions of the knee. The patient population is heterogeneous, involving different kinds of joint surface lesions: focal cartilage lesions, osteochondral defects and mild to moderate osteoarthritis, including multiple defects.

Conditions

Cartilage or Osteochondral Defects in the Knee; Up to Moderate Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 60 Months

  Change from Baseline to 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome). The change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.

  Baseline, 60 Months

Secondary Outcomes (26)

• Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score Change From Baseline to 60 Months

  Baseline, 60 Months

• Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Score Change From Baseline to 60 Months

  Baseline, 60 Months

• Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Score Change From Baseline to 60 Months

  Baseline, 60 Months

• Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Score Change From Baseline to 60 Months

  Baseline, 60 Months

• Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports Score Change From Baseline to 60 Months

  Baseline, 60 Months

Study Arms (2)

Agili-C

EXPERIMENTAL

Device: Agili-C implant

Surgical Standard of Care (SSOC)

ACTIVE COMPARATOR

Procedure: SSOC

Interventions

Agili-C implant DEVICE

Agili-C implant

Agili-C

SSOC PROCEDURE

microfracture and/or debridement

Surgical Standard of Care (SSOC)

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• Up to 3 treatable joint surface lesion(s), ICRS Grade III or above, on the femoral condyles and/or trochlea
• Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation
• Must be physically and mentally willing and able to comply with the post-operative rehabilitation protocol and scheduled clinical and radiographic visits
• Signed and dated the IRB/Ethics Committee approved Informed Consent Form and HIPPA (if applicable)
• Non-responsive to physical therapy for at least 3-4 weeks

You may not qualify if:

• KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain =0, pain free =100)
• Bony defect depth deeper than 8mm, according to baseline MRI/X-ray/arthroscopy
• Articular cartilage lesions in the tibia or the patella, ICRS grades IVa or above
• Osteoarthritis of the index knee graded 4 according to the Kellgren-Lawrence Grading
• Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal)
• Malalignment more than 8 degrees varus OR 8 degrees valgus according to standing X-ray
• Lack of functional remaining meniscus, at least 5mm rim at the end of the procedure
• Meniscal transplantation in the past 6 months
• Any known tumor of the index knee
• Any known history of intra-articular or osseous infection of the index knee
• Any evidence of active infection anywhere in the body. Urinary Tract Infection (UTI) patients can be included following antibiotic treatment, and provided that two consecutive cultures are negative (taken within at least 2 weeks of each other)
• Any known history of inflammatory arthropathy or crystal-deposition arthropathy
• Any known systemic cartilage and/or bone disorder, such as but not limited to, osteoporosis, chondrodysplasia or osteogenesis imperfecta
• Body Mass Index (BMI) \> 35
• Chemotherapy in the past 12 months

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (26)

Horizon Clinical Research

San Diego, California, 91942, United States

Location

LSU Healthcare Network Orthopedic & Sports Medicine

New Orleans, Louisiana, 70112, United States

Location

Peninsula Orthopaedic Associates

Salisbury, Maryland, 21804, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02467, United States

Location

University of Missouri, Missouri Orthopaedic Institute

Columbia, Missouri, 65212, United States

Location

NYU Langone Orthopedic Hospital

New York, New York, 10003, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Ohio State University, Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Arlington Orthopedic Associates

Arlington, Texas, 76015, United States

Location

OrthoVirginia

Richmond, Virginia, 23294, United States

Location

AZ Monica

Antwerp, Belgium

Location

Uzsoki Utcai Kórház

Budapest, 1114, Hungary

Location

Kastélypark Klinika

Tata, 2892, Hungary

Location

Assaf Harofeh Medical Center

Be’er Ya‘aqov, 60930, Israel

Location

"Carmel" Medical Center

Haifa, 3436212, Israel

Location

Hadassah Medical Center

Jerusalem, Israel

Location

Hasharon Hospital, Petach Tikva

Petah Tikva, Israel

Location

Souraski Medical Center

Tel Aviv, 6423906, Israel

Location

Humanitas Gavazzeni

Bergamo, Italy

Location

Istituto Clinico Humanitas

Rozzano, Italy

Location

Specialist Hospital. Louis Rydygier in Krakow

Krakow, Poland

Location

County Hospital Timis Othopedy and Trauma Clinic

Timișoara, Romania

Location

Atlas General hospital

Belgrade, Serbia

Location

Clinic for Orthopedic Surgery "Banjica"

Belgrade, Serbia

Location

Clinical Center of Vojvodina

Novi Sad, Serbia

Location

Related Publications (2)

• Kon E, De Caro F, Dasa V, M Scopp J, Di Matteo B, Flanigan D, Shabshin N, Strickland S, Altschuler N. Female patients report comparable results to males after the implantation of an aragonite-based scaffold for the treatment of knee chondral and osteochondral defects: a gender-based analysis of a RCT at 4 years' follow-up. J Orthop Traumatol. 2025 Mar 13;26(1):17. doi: 10.1186/s10195-025-00829-y.

  PMID: 40080289 DERIVED

• Altschuler N, Zaslav KR, Di Matteo B, Sherman SL, Gomoll AH, Hacker SA, Verdonk P, Dulic O, Patrascu JM, Levy AS, Robinson D, Kon E. Aragonite-Based Scaffold Versus Microfracture and Debridement for the Treatment of Knee Chondral and Osteochondral Lesions: Results of a Multicenter Randomized Controlled Trial. Am J Sports Med. 2023 Mar;51(4):957-967. doi: 10.1177/03635465231151252. Epub 2023 Feb 13.

  PMID: 36779614 DERIVED

Results Point of Contact

• Title: Senior Manager Clinical Compliance
• Organization: Smith+Nephew, Inc

datasharing.gcs@smith-nephew.com

07811407089

Study Officials

• Elizaveta Kon, MD

  Istituto Clinico Humanitas, Via A. Manzoni 56, Rozzano, Milano, Italy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-Label, adaptive design with interim analyses
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label Randomized Controlled Trial

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: October 3, 2017
• Study Start: September 25, 2017
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: December 5, 2025
• Results First Posted: December 5, 2025

Record last verified: 2024-11

Locations

US (11); HU (2); SE (3); IT (2); IL (5); PL (1); RO (1); BE (1)