Agili-C™ Implant Performance Evaluation

A Prospective Multicenter Open-label Randomized Controlled Trial of Agili-C™ vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee

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.

Study Overview

• Status: Completed
• Conditions: Cartilage or Osteochondral Defects in the Knee; Up to Moderate Osteoarthritis
• Intervention / Treatment: Device: Agili-C implant; Procedure: SSOC

Detailed Description

This is a prospective, multicenter, open-label, randomized, and controlled trial of Agili-C™ vs. SSOC for the repair of joint surface lesions.

Follow-up visits will be performed at 2 weeks and at 3, 6, 12, 18, 24, 36, 48 and 60 months post-procedure to evaluate the patient's knee condition and clinical health.

The following questionnaires: KOOS, IKDC Knee Examination Form 2000, IKDC Subjective Knee Evaluation , SF-12 Health Survey, Tegner Activity Score will be completed at baseline and at 6, 12, 18, 24, 36, 48 and 60 months.

Anterior-Posterior (A/P) and Lateral knee X-rays will be taken at 2 weeks and at 6, 12, 18 24, 36, 48 and 60 months post procedure. MRI according to specific protocol will be performed at 12 and 24 months.

• Study Type: Interventional
• Enrollment (Actual): 251
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • AZ Monica
• Hungary
  • Budapest, Hungary, 1114
    • Uzsoki Utcai Kórház
  • Tata, Hungary, 2892
    • Kastélypark Klinika
• Israel
  • Be’er Ya‘aqov, Israel, 60930
    • Assaf Harofeh Medical Center
  • Haifa, Israel, 3436212
    • "Carmel" Medical Center
  • Jerusalem, Israel
    • Hadassah Medical Center
  • Petah Tikva, Israel
    • Hasharon Hospital, Petach Tikva
  • Tel Aviv, Israel, 6423906
    • Souraski medical center
• Italy
  • Bergamo, Italy
    • Humanitas Gavazzeni
  • Rozzano, Italy
    • Istituto Clinico Humanitas
• Poland
  • Krakow, Poland
    • Specialist Hospital. Louis Rydygier in Krakow
• Romania
  • Timișoara, Romania
    • County Hospital Timis Othopedy and Trauma Clinic
• Serbia
  • Belgrade, Serbia
    • Atlas General hospital
  • Belgrade, Serbia
    • Clinic for Orthopedic Surgery "Banjica"
  • Novi Sad, Serbia
    • Clinical Center of Vojvodina
• United States
  • California
    • San Diego, California, United States, 91942
      • Horizon Clinical Research
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • LSU Healthcare Network Orthopedic & Sports Medicine
  • Maryland
    • Salisbury, Maryland, United States, 21804
      • Peninsula Orthopaedic Associates
  • Massachusetts
    • Boston, Massachusetts, United States, 02467
      • Brigham and Women's Hospital
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri, Missouri Orthopaedic Institute
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
    • New York, New York, United States, 10003
      • NYU Langone Orthopedic Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University, Wexner Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Texas
    • Arlington, Texas, United States, 76015
      • Arlington Orthopedic Associates
  • Virginia
    • Richmond, Virginia, United States, 23294
      • OrthoVirginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 21 -75 years
2. Up to 3 treatable joint surface lesion(s), ICRS Grade III or above, on the femoral condyles and/or trochlea
3. Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation
4. Must be physically and mentally willing and able to comply with the post-operative rehabilitation protocol and scheduled clinical and radiographic visits
5. Signed and dated the IRB/Ethics Committee approved Informed Consent Form and HIPPA (if applicable)
6. Non-responsive to physical therapy for at least 3-4 weeks

Exclusion Criteria:

1. KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain =0, pain free =100)
2. Bony defect depth deeper than 8mm, according to baseline MRI/X-ray/arthroscopy
3. Articular cartilage lesions in the tibia or the patella, ICRS grades IVa or above
4. Osteoarthritis of the index knee graded 4 according to the Kellgren-Lawrence Grading
5. Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal)
6. Malalignment more than 8 degrees varus OR 8 degrees valgus according to standing X-ray
7. Lack of functional remaining meniscus, at least 5mm rim at the end of the procedure
8. Meniscal transplantation in the past 6 months
9. Any known tumor of the index knee
10. Any known history of intra-articular or osseous infection of the index knee
11. 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)
12. Any known history of inflammatory arthropathy or crystal-deposition arthropathy
13. Any known systemic cartilage and/or bone disorder, such as but not limited to, osteoporosis, chondrodysplasia or osteogenesis imperfecta
14. Body Mass Index (BMI) > 35
15. Chemotherapy in the past 12 months
16. Any previous surgical cartilage treatment (such as: microfracture, ACI, OATS, etc.) in the index knee within the last 6 months
17. Any previous ligamentous repair or malalignment correction in the index knee within the last 6 months
18. History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate
19. Patient who is pregnant or intends to become pregnant during the study
20. History of any significant systemic disease, such as but not limited to: HIV, hepatitis, HTLV, syphilis, and coagulopathies
21. Known substance or alcohol abuse
22. Participation in other clinical trials within 60 days prior to the study or concurrent with the study
23. Known insulin dependent diabetes mellitus
24. Unable to undergo either MRI or X-ray
25. Use of anticoagulation medication or antiaggregant medication; however up to 100 mg Acetylsalicylic acid (ASA) daily is allowed
26. Previous intra-articular steroid injection within the last 1 month
27. Prisoners
28. Uncontained lesion - Lack of vital bone wall, at least 2mm thick, completely surrounding the lesion - based on MRI/X-ray/arthroscopy
29. Inability to position the implant 2mm recessed relative to the articular surface - based on MRI/X-ray/arthroscopy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Agili-C	Device: Agili-C implant; Agili-C implant
Active Comparator: Surgical Standard of Care (SSOC)	Procedure: SSOC; microfracture and/or debridement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score Change From Baseline to 60 Months	Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score consists of 9 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a 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
Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Score Change From Baseline to 60 Months	Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Score consists of 4 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a 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
Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Score Change From Baseline to 60 Months	Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Score consists of 17 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a 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
Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Score Change From Baseline to 60 Months	Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Score consists of 7 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a 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
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports Score Change From Baseline to 60 Months	Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports Score consists of 5 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a 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
Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score Responder Rate Change From Baseline to 60 Months	Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score consists of 5 subscales. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Subscale scores are combined to produce the Overall Score that is transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome. Responder rate was defined as the proportion of participants achieving ≥30-point improvement from baseline to 60 months in the KOOS Overall Score. The change from baseline data is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.	Baseline, 60 Months
Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months and 48 Months	Change from Baseline to 36 Months and 48 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).	Baseline, 36 Months, and 48 Months
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score Change From Baseline to 36 Months, 48 Months, and 60 Months	Change from Baseline to 36 Months, 48 Months, and 60 Months in the International Knee Documentation Committee (IKDC) Subjective Evaluation score. The IKDC Score was developed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment, including patients with meniscal injuries. The possible score ranges from 0 to 100, with a higher score indicating no limitation with daily or sporting activities and the absence of symptoms (i.e., a better outcome).	Baseline, 36 Months, 48 Months, and 60 Months
Tegner Activity Scale Change From Baseline to 36 Months, 48 Months, and 60 Months	Change from Baseline to 36 Months, 48 Months, and 60 Months in Tegner activity scale. The Tegner activity scale was designed as a score of activity level to complement other functional scores for patients with ligamentous injuries. The Tegner activity scale is a numerical scale ranging from 0 to 10, with a higher score indicating higher levels of activity (i.e., a better outcome).	Baseline, 36 Months, 48 Months, and 60 Months
Short Form Survey (SF-12) Physical Component Score Change From Baseline to 36 Months, 48 Months, and 60 Months	Change from Baseline to 36 Months, 48 Months, and 60 Months in SF-12 Physical Component Score. The SF-12 Physical Component Score assesses health related quality of life. The score is on a scale ranging from 0 to 100, with a higher score indicating a better outcome.	Baseline, 36 Months, 48 Months, and 60 Months
Short Form Survey (SF-12) Mental Component Score Change From Baseline to 36 Months, 48 Months, and 60 Months	Change from Baseline to 36 Months, 48 Months, and 60 Months in SF-12 Mental Component Score. The SF-12 Mental Component Score assesses mental health and well-being. The score is on a scale ranging from 0 to 100, with a higher score indicating a better outcome.	Baseline, 36 Months, 48 Months, and 60 Months
Chondral Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months	Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with Chondral Lesions 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).	Baseline, 36 Months, 48 Months, and 60 Months
Osteochondral Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months	Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with Osteochondral Lesions 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).	Baseline, 36 Months, 48 Months, and 60 Months
Single Lesion: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months	Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with a Single Lesion 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).	Baseline, 36 Months, 48 Months, and 60 Months
Multiple Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months	Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with Multiple Lesions 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).	Baseline, 36 Months, 48 Months, and 60 Months
Level of Osteoarthritis (Kellgren-Lawrence Grade 0-1): Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months	Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants based on their level of osteoarthritis 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). Participants were categorized as without osteoarthritis based on Kellgren-Lawrence (K/L) grade of 0 to 1. K/L grading included Grade 0 (No evidence of osteoarthritis), Grade 1 (Doubtful), Grade 2 (Minimal), and Grade 3 (Moderate).	Baseline, 36 Months, 48 Months, and 60 Months
Level of Osteoarthritis (Kellgren-Lawrence Grade 2-3): Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months	Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants based on their level of osteoarthritis 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). Participants categorized with osteoarthritis based on Kellgren-Lawrence (K/L) grade of 2 to 3. K/L grading included Grade 0 (No evidence of osteoarthritis), Grade 1 (Doubtful), Grade 2 (Minimal), or Grade 3 (Moderate).	Baseline, 36 Months, 48 Months, and 60 Months
Total Lesion Area ≤3cm²: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months	Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with a lesion area ≤3cm² 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).	Baseline, 36 Months, 48 Months, and 60 Months
Total Lesion Area >3cm²: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months	Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with a lesion area >3cm² 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).	Baseline, 36 Months, 48 Months, and 60 Months
Without Previous Ligament Reconstruction: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months	Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants without previous ligament reconstruction was 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).	Baseline, 36 Months, 48 Months, and 60 Months
With Previous Ligament Reconstruction: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months	Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with previous ligament reconstruction was 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).	Baseline, 36 Months, 48 Months, and 60 Months
With Intact Meniscus: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months	Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized by a meniscus status of intact meniscus (i.e., without a concomitant meniscectomy) was 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).	Baseline, 36 Months, 48 Months, and 60 Months
With Previous Partial Meniscectomy: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months	Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized by a meniscus status of previous partial meniscectomy (i.e., with a prior meniscectomy) was 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).	Baseline, 36 Months, 48 Months, and 60 Months
With Concomitant Partial Meniscectomy: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months	Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized by a meniscus status of concomitant partial meniscectomy (i.e., with a concomitant meniscectomy) was 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).	Baseline, 36 Months, 48 Months, and 60 Months
Active Pre-injury: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months	Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized as active prior to injury (based on Tegner score) was 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).	Baseline, 36 Months, 48 Months, and 60 Months
Non-Active Pre-injury: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months	Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized as non-active prior to injury (based on Tegner score) was 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).	Baseline, 36 Months, 48 Months, and 60 Months

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Elizaveta Kon, MD, Istituto Clinico Humanitas, Via A. Manzoni 56, Rozzano, Milano, Italy

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2017
• Primary Completion (Actual): November 14, 2024
• Study Completion (Actual): November 14, 2024

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Estimated): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: CLN0021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No