Cartilage or Osteochondral Defects in the KneeNCT02423629
Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects
A study testing Agili-C™ implantation procedure in people with Cartilage or Osteochondral Defects in the Knee, run by Smith & Nephew, Inc. at 8 sites in 8 countries.
Trial summary
Evaluate the performance of the Agili-C™ in the repair of Cartilage and Osteochondral defects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cartilage or Osteochondral Defects in the Knee
- What is being tested?
- Agili-C™ implantation procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 8 sitesin 8 countries
- Study dates
- May 2014to 19 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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
Show all 21Show fewer
- 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
- Patient who is pregnant or intends to become pregnant during the study
- History of any significant systemic disease, such as but not limited to, HIV infection, hepatitis infection or HTLV infection; known coagulopathies, that might compromise the subject's welfare
- Known substance abuse or alcohol abuse
- Participation in other clinical trials within 30 days prior to the study or concurrent with the study
- Known insulin dependent diabetes mellitus
- Unable to undergo MRI or X-ray
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
About this study
Official title: Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects (OCD)
Evaluate the performance of the Agili-C™ in the repair of Cartilage and Osteochondral defects.
Read the detailed description
Agili-C™ implant is a CE marked, bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of articular cartilage and/or osteochondral defects.
The Agili-C™ implant will be implanted using the Agili-Kit™ surgical toolset which is designed for the precise preparation of sites in cartilage and osteochondral defects, for implanting the Agili-C™ implant
- Being tested
- Agili-C™ implantation procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agili-C™ implantation procedureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Agili-C™ implantation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
• The KOOS Pain Subscale relative to baseline
The KOOS pain subscale is evaluated at 6m, 12m, 18m \& 24m
Measured: 24 Months
Secondary outcomes (8)
• Improvement in other KOOS subscales relative to baseline
Other KOOS subscales are evaluated at 6m, 12m, 18m \& 24m
Measured: 24 Months
• Improvement in IKDC Subjective Knee Score relative to baseline
IKDC Subjective Knee Score is evaluated at 6m, 12m, 18m \& 24m
Measured: 24 Months
• Improvement in SF-36 Survey
SF-36 Survey is evaluated at 6m, 12m, 18m \& 24m
Measured: 24 Months
• Improvement in Tegner Score
Tegner Score is evaluated at 6m, 12m, 18m \& 24m
Measured: 24 Months
• Improvement in Lysholm Knee Scoring Scale
Lysholm Knee Scoring Scale is evaluated at 6m, 12m, 18m \& 24m
Measured: 24 Months
• Joint Space maintenance rate according to X-ray
Joint Space maintenance rate is evaluated at 12m \& 24m
Measured: 24 Months
• Defect Fill according to MRI
Defect Fill according to MRI is evaluated at 6m, 12m, 18m \& 24m
Measured: 24 Months
Improvement of Overall KOOS (average of all KOOS Subscales) relative to baseline
The KOOS Overall is evaluated at 6, 12,18 \& 24 months
Measured: 24 mMonths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startMay 2014
- Primary completion19 Nov 2019
- Study completion19 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage or Osteochondral Defects in the KneeStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizaveta Kon, MD, Principal investigator, Rizzoli Institute, Bologna , Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423629
- Sponsor's protocol ID
- CLN0019
- Status last verified
- Oct 2019
- First submitted
- 3 Dec 2014
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects (OCD)
- ClinicalTrials.gov ID
- NCT02423629
- Acronym / sponsor ID
- CLN0019
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- 19 Nov 2019 (actual)
- Study completion
- 19 Nov 2019 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the performance of the Agili-C™ in the repair of Cartilage and Osteochondral defects.
Detailed description
Agili-C™ implant is a CE marked, bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of articular cartilage and/or osteochondral defects.
The Agili-C™ implant will be implanted using the Agili-Kit™ surgical toolset which is designed for the precise preparation of sites in cartilage and osteochondral defects, for implanting the Agili-C™ implant
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Agili C™ | Other | Device: Agili-C™ implantation procedureCandidates 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Agili-C™ implantation procedureCandidates 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. | Device | Agili C™ |
Primary outcome
• The KOOS Pain Subscale relative to baseline
Time frame: 24 Months
The KOOS pain subscale is evaluated at 6m, 12m, 18m \& 24m
8 secondary outcomes
• Improvement in other KOOS subscales relative to baseline
Time frame: 24 Months
• Improvement in IKDC Subjective Knee Score relative to baseline
Time frame: 24 Months
• Improvement in SF-36 Survey
Time frame: 24 Months
• Improvement in Tegner Score
Time frame: 24 Months
• Improvement in Lysholm Knee Scoring Scale
Time frame: 24 Months
• Joint Space maintenance rate according to X-ray
Time frame: 24 Months
• Defect Fill according to MRI
Time frame: 24 Months
Improvement of Overall KOOS (average of all KOOS Subscales) relative to baseline
Time frame: 24 mMonths
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizaveta Kon, MD principal investigator
Rizzoli Institute, Bologna , Italy
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agili-C™ implantation procedure in people with Cartilage or Osteochondral Defects in the Knee, run by Smith & Nephew, Inc. at 8 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Austria, Belgium, Israel, Italy, Poland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• The KOOS Pain Subscale relative to baseline (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.