Agili-C™ Implant Performance Evaluation
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03299959 |
Recruitment Status :
Active, not recruiting
First Posted : October 3, 2017
Last Update Posted : February 11, 2020
|
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | September 14, 2017 | ||||||
First Posted Date ICMJE | October 3, 2017 | ||||||
Last Update Posted Date | February 11, 2020 | ||||||
Actual Study Start Date ICMJE | September 5, 2017 | ||||||
Estimated Primary Completion Date | January 1, 2023 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
KOOS Score [ Time Frame: Preoperative until 2 years postoperatively ] Knee Injury and Osteoarthritis Outcome Score (KOOS)
|
||||||
Original Primary Outcome Measures ICMJE | Not Provided | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Agili-C™ Implant Performance Evaluation | ||||||
Official Title ICMJE | 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 | ||||||
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. | ||||||
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 and 24 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 and 24 months. Anterior-Posterior (A/P) and Lateral knee X-rays will be taken at 2 weeks and at 6, 12, 18 and 24 months post procedure. MRI according to specific protocol will be performed at 12 and 24 months. |
||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Open-label Randomized Controlled Trial Masking: None (Open Label)Masking Description: Open-Label, adaptive design with interim analyses Primary Purpose: Treatment
|
||||||
Condition ICMJE |
|
||||||
Intervention ICMJE |
|
||||||
Study Arms ICMJE |
|
||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
251 | ||||||
Original Enrollment ICMJE | Not Provided | ||||||
Estimated Study Completion Date ICMJE | January 1, 2023 | ||||||
Estimated Primary Completion Date | January 1, 2023 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender ICMJE |
|
||||||
Ages ICMJE | 21 Years to 75 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Belgium, Hungary, Israel, Italy, Poland, Romania, Serbia, United States | ||||||
Removed Location Countries | France, Slovenia | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03299959 | ||||||
Other Study ID Numbers ICMJE | CLN0021 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
|
||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Cartiheal (2009) Ltd | ||||||
Study Sponsor ICMJE | Cartiheal (2009) Ltd | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
|
||||||
PRS Account | Cartiheal (2009) Ltd | ||||||
Verification Date | February 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |