Trials / Completed
CompletedNCT03299959
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 251 (actual)
- Sponsor
- Smith & Nephew, Inc. · Industry
- Sex
- All
- Age
- 21 Years – 75 Years
- Healthy volunteers
- Not accepted
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, 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Agili-C implant | Agili-C implant |
| PROCEDURE | SSOC | microfracture and/or debridement |
Timeline
- Start date
- 2017-09-25
- Primary completion
- 2024-11-14
- Completion
- 2024-11-14
- First posted
- 2017-10-03
- Last updated
- 2025-12-05
- Results posted
- 2025-12-05
Locations
26 sites across 8 countries: United States, Belgium, Hungary, Israel, Italy, Poland, Romania, Serbia
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03299959. Inclusion in this directory is not an endorsement.