Who is sponsoring NCT03299959?

NCT03299959 is sponsored by Smith & Nephew, Inc..

What drugs are being tested in NCT03299959?

Interventions in NCT03299959: Agili-C implant, SSOC.

What condition does NCT03299959 study?

NCT03299959 studies Cartilage or Osteochondral Defects in the Knee, Up to Moderate Osteoarthritis.

Is NCT03299959 still recruiting?

NCT03299959 is currently completed. Last updated 5 December 2025.

Are results published for NCT03299959?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-12-05 · How we verify

NCT03299959

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Agili-C™ Implant Performance Evaluation

Completed NA Results posted Last updated 5 December 2025

What this trial tests

NA trial testing Agili-C implant in Cartilage or Osteochondral Defects in the Knee in 251 participants. Completed in 14 November 2024.

Timeline

25 September 2017

Primary endpoint
14 November 2024

14 November 2024

Quick facts

Lead sponsor	Smith & Nephew, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	251
Start date	25 September 2017
Primary completion	14 November 2024
Estimated completion	14 November 2024
Sites	26 locations across Italy, Belgium, Serbia, Israel, Hungary, Poland, Romania, United States

Drugs / interventions tested

Agili-C implant
SSOC

Conditions studied

Cartilage or Osteochondral Defects in the Knee — all drugs for Cartilage or Osteochondral Defects in the Knee →
Up to Moderate Osteoarthritis — all drugs for Up to Moderate Osteoarthritis →

Sponsor

Smith & Nephew, Inc. — full company profile →

Who can join

Adults 21 to 75, any sex, with Cartilage or Osteochondral Defects in the Knee or Up to Moderate Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score Change From Baseline to 60 Months Secondary · Baseline, 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.

Group	Value	95% CI
Agili-C™	37.71	34.47 – 40.93
Surgical Standard of Care (SSOC)	18.68	13.89 – 23.43

Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Score Change From Baseline to 60 Months Secondary · Baseline, 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.

Group	Value	95% CI
Agili-C™	45.22	40.49 – 49.93
Surgical Standard of Care (SSOC)	22.29	15.53 – 29.15

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

Group	Value	95% CI
Agili-C™	33.03	29.84 – 36.18
Surgical Standard of Care (SSOC)	16.45	11.84 – 21.12

Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Score Change From Baseline to 60 Months Secondary · Baseline, 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.

Group	Value	95% CI
Agili-C™	30.52	27.00 – 34.02
Surgical Standard of Care (SSOC)	15.52	10.38 – 20.72

Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports Score Change From Baseline to 60 Months Secondary · Baseline, 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.

Group	Value	95% CI
Agili-C™	47.32	42.46 – 52.18
Surgical Standard of Care (SSOC)	25.11	18.15 – 32.08

Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score Responder Rate Change From Baseline to 60 Months Secondary · Baseline, 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 distributi

Group	Value	95% CI
Agili-C™	0.74	0.67 – 0.81
Surgical Standard of Care (SSOC)	0.34	0.24 – 0.46

Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months and 48 Months Secondary · Baseline, 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

Change from Baseline to 36 Months

Group	Value	95% CI
Agili-C™	41.4	-6.8 – 86.4
Surgical Standard of Care (SSOC)	19.3	-7.8 – 55.7

Change from Baseline to 48 months

Group	Value	95% CI
Agili-C™	41.9	0.0 – 86.4
Surgical Standard of Care (SSOC)	17.3	-29.6 – 59.5

International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score Change From Baseline to 36 Months, 48 Months, and 60 Months Secondary · Baseline, 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).

Change from Baseline to 36 Months

Group	Value	95% CI
Agili-C™	41.1	-20.7 – 82.8
Surgical Standard of Care (SSOC)	18.8	-11.5 – 71.3

Change from Baseline to 48 Months

Group	Value	95% CI
Agili-C™	41.6	-13.8 – 82.8
Surgical Standard of Care (SSOC)	17.9	-16.1 – 69.0

Change from Baseline to 60 Months

Group	Value	95% CI
Agili-C™	41.0	-8.1 – 82.8
Surgical Standard of Care (SSOC)	18.4	-13.8 – 70.1

Tegner Activity Scale Change From Baseline to 36 Months, 48 Months, and 60 Months Secondary · Baseline, 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).

Change from Baseline to 36 Months

Group	Value	95% CI
Agili-C™	2.3	-3 – 9
Surgical Standard of Care (SSOC)	1.0	-1 – 8

Change from Baseline to 48 Months

Group	Value	95% CI
Agili-C™	2.2	-1 – 8
Surgical Standard of Care (SSOC)	0.9	-2 – 8

Change from Baseline to 60 Months

Group	Value	95% CI
Agili-C™	2.1	-2 – 7
Surgical Standard of Care (SSOC)	0.9	-2 – 8

Short Form Survey (SF-12) Physical Component Score Change From Baseline to 36 Months, 48 Months, and 60 Months Secondary · Baseline, 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.

Change from Baseline to 36 Months

Group	Value	95% CI
Agili-C™	15.4	-4.0 – 39.4
Surgical Standard of Care (SSOC)	7.3	-18.4 – 40.3

Change from Baseline to 48 Months

Group	Value	95% CI
Agili-C™	15.5	-14.2 – 36.2
Surgical Standard of Care (SSOC)	6.4	-14.8 – 38.7

Change from Baseline to 60 Months

Group	Value	95% CI
Agili-C™	15.2	-20.9 – 39.0
Surgical Standard of Care (SSOC)	6.1	-16.3 – 42.2

Short Form Survey (SF-12) Mental Component Score Change From Baseline to 36 Months, 48 Months, and 60 Months Secondary · Baseline, 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.

Change from Baseline to 36 Months

Group	Value	95% CI
Agili-C™	5.4	-23.2 – 36.4
Surgical Standard of Care (SSOC)	1.7	-16.6 – 37.3

Change from Baseline to 48 Months

Group	Value	95% CI
Agili-C™	5.2	-23.5 – 38.1
Surgical Standard of Care (SSOC)	1.7	-19.4 – 34.5

Change from Baseline to 60 Months

Group	Value	95% CI
Agili-C™	4.3	-27.7 – 36.4
Surgical Standard of Care (SSOC)	1.4	-16.9 – 37.3

Chondral Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Secondary · Baseline, 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 repr

Change from Baseline to 36 Months

Group	Value	95% CI
Agili-C™	42.9	-6.8 – 86.4
Surgical Standard of Care (SSOC)	19.8	-7.8 – 55.7

Change from Baseline to 48 Months

Group	Value	95% CI
Agili-C™	42.1	0.0 – 86.4
Surgical Standard of Care (SSOC)	19.0	-1.5 – 59.5

Change from Baseline to 60 Months

Group	Value	95% CI
Agili-C™	41.3	-2.5 – 86.4
Surgical Standard of Care (SSOC)	18.5	-0.6 – 64.1

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from surgery through the end of study, approximately 60 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Agili-C™

Serious: 49/167 (29%)

Deaths: 1/167

Surgical Standard of Care (SSOC)

Serious: 25/84 (30%)

Deaths: 0/84

Serious adverse events (52 terms)

Reaction	System	Agili-C™	Surgical Standard of Care …
Increased transient or chronic pain in the operated joint, compared to baseline	Musculoskeletal and connective tissue disorders	—	—
covid-19	Infections and infestations	—	—
contusion	Injury, poisoning and procedural complications	—	—
arthralgia	Musculoskeletal and connective tissue disorders	—	—
meniscus injury	Injury, poisoning and procedural complications	—	—
inguinal hernia	Gastrointestinal disorders	—	—
tendon rupture	Injury, poisoning and procedural complications	—	—
osteoarthritis	Musculoskeletal and connective tissue disorders	—	—
sciatica	Nervous system disorders	—	—
Progression of osteoarthritis compared to baseline	Musculoskeletal and connective tissue disorders	—	—
coronary artery disease	Cardiac disorders	—	—
myocardial infarction	Cardiac disorders	—	—
conductive deafness	Ear and labyrinth disorders	—	—
abdominal hernia	Gastrointestinal disorders	—	—
abdominal pain	Gastrointestinal disorders	—	—
haemorrhoids	Gastrointestinal disorders	—	—
asthenia	General disorders	—	—
cholecystitis chronic	Hepatobiliary disorders	—	—
cholelithiasis	Hepatobiliary disorders	—	—
allergy to metals	Immune system disorders	—	—
covid-19 pneumonia	Infections and infestations	—	—
ankle fracture	Injury, poisoning and procedural complications	—	—
cartilage injury	Injury, poisoning and procedural complications	—	—
hand fracture	Injury, poisoning and procedural complications	—	—
injury	Injury, poisoning and procedural complications	—	—

Other adverse events (161 terms — click to expand)

Reaction	System	Agili-C™	Surgical Standard of Care …
Increased transient or chronic pain in the operated joint, compared to baseline	Musculoskeletal and connective tissue disorders	—	—
arthralgia	Musculoskeletal and connective tissue disorders	—	—
sciatica	Nervous system disorders	—	—
Increased swelling (or effusion) in the operated joint, compared to baseline	Musculoskeletal and connective tissue disorders	—	—
ligament sprain	Injury, poisoning and procedural complications	—	—
covid-19	Infections and infestations	—	—
contusion	Injury, poisoning and procedural complications	—	—
tendon disorder	Musculoskeletal and connective tissue disorders	—	—
dermatitis contact	Skin and subcutaneous tissue disorders	—	—
drug hypersensitivity	Immune system disorders	—	—
back pain	Musculoskeletal and connective tissue disorders	—	—
haemarthrosis	Musculoskeletal and connective tissue disorders	—	—
pain in extremity	Musculoskeletal and connective tissue disorders	—	—
patellofemoral pain syndrome	Musculoskeletal and connective tissue disorders	—	—
tendonitis	Musculoskeletal and connective tissue disorders	—	—
gastroenteritis	Infections and infestations	—	—
pharyngitis streptococcal	Infections and infestations	—	—
epicondylitis	Injury, poisoning and procedural complications	—	—
head injury	Injury, poisoning and procedural complications	—	—
iliotibial band syndrome	Injury, poisoning and procedural complications	—	—
joint injury	Injury, poisoning and procedural complications	—	—
muscle strain	Injury, poisoning and procedural complications	—	—
road traffic accident	Injury, poisoning and procedural complications	—	—
bursitis	Musculoskeletal and connective tissue disorders	—	—
plantar fasciitis	Musculoskeletal and connective tissue disorders	—	—
Muscle atrophy compared to baseline	Musculoskeletal and connective tissue disorders	—	—
Progression of osteoarthritis compared to baseline	Musculoskeletal and connective tissue disorders	—	—
Wound complications (wound dehiscence, hematoma, site drainage or superficial infection)	Skin and subcutaneous tissue disorders	—	—
atrioventricular block second degree	Cardiac disorders	—	—
arteriovenous malformation	Congenital, familial and genetic disorders	—	—
middle ear effusion	Ear and labyrinth disorders	—	—
hypothyroidism	Endocrine disorders	—	—
secondary hypogonadism	Endocrine disorders	—	—
blepharospasm	Eye disorders	—	—
cataract	Eye disorders	—	—
eye irritation	Eye disorders	—	—
eye pain	Eye disorders	—	—
eyelid ptosis	Eye disorders	—	—
retinal vein occlusion	Eye disorders	—	—
vision blurred	Eye disorders	—	—

Most-reported serious reactions: Increased transient or chronic pain in the operated joint, compared to baseline, covid-19, contusion, arthralgia, meniscus injury, inguinal hernia, tendon rupture, osteoarthritis.

Data from ClinicalTrials.gov NCT03299959 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Articular cartilage and osteochondral tissue engineering techniques: Recent advances and challenges.
Wei W, Dai H. · · 2021 · cited 206× · PMID 34136726 · DOI 10.1016/j.bioactmat.2021.05.011
Aragonite-Based Scaffold Versus Microfracture and Debridement for the Treatment of Knee Chondral and Osteochondral Lesions: Results of a Multicenter Randomized Controlled Trial.
Altschuler N, Zaslav KR, Di Matteo B, Sherman SL, et al · · 2023 · cited 23× · PMID 36779614 · DOI 10.1177/03635465231151252
Joint Surface Lesions in the Knee Treated with an Acellular Aragonite-Based Scaffold: A 3-Year Follow-Up Case Series.
Van Genechten W, Vuylsteke K, Struijk C, Swinnen L, et al · · 2021 · cited 18× · PMID 33448238 · DOI 10.1177/1947603520988164
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.
Kon E, De Caro F, Dasa V, M Scopp J, et al · · 2025 · cited 4× · PMID 40080289 · DOI 10.1186/s10195-025-00829-y

Verify or expand the search:

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Currently open trials in the same condition.

NCT05685316 — COPLA® Cartilage Implant Pilot Clinical Trial · NA · active not recruiting

Other Smith & Nephew, Inc. trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03299959 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Smith & Nephew, Inc.
Last refreshed: 5 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03299959.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03299959

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (52 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Cartilage or Osteochondral Defects in the Knee

Other Smith & Nephew, Inc. trials

Verify against primary sources