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Clinical Evidence



New 5-year results show sustained performance

With new randomized controlled trial data confirmed, there’s no need to wait and see if the CARTIHEAL Implant delivers durable clinical results.1 When compared to the current surgical standard (microfracture and debridement), patients treated with the CARTIHEAL Implant experienced:7

Find out why clinical evidence continues to support the CARTIHEAL Implant with our latest blogs and data summaries.

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Advantages of using the CARTIHEAL Implant

  • Can be used to repair cartilage, restore bone and relieve pain1-4
  • Simple, single-stage surgical procedure with no donor tissue required.
  • A proprietary biomaterial that is porous and biocompatible.
  • Clinically meaningful improvements in pain, function and quality of life, demonstrated in an RCT.*1,2
  • Twice the pain reduction versus microfracture or debridement, demonstrated in an RCT.*1,2
  • 87% reduction in the relative risk of total knee arthroplasty or osteotomy, demonstrated in an RCT.**2
  • Significant improvements in patient-reported outcome measures (KOOS, IKDC), with superior results when compared to the surgical standard of care.***1,2
  • Helps the body repair knee cartilage and restore damaged bone,1-4 and shown to be largely resorbed by the body within 18 months.1,4,5
  • The only device approved for the treatment of knee cartilage and osteochondral defects in patients with or without mild to moderate osteoarthritis (KL 0-3).****6
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Important safety and risk information

Rx only

INTENDED USE

Treat articular cartilage and/or osteochondral defects.

INDICATIONS FOR USE

The AGILI-C™ scaffold is indicated for the treatment of an International Cartilage Repair Society grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2, without severe osteoarthritis (Kellgren-Lawrence grade 0-3).

CONTRAINDICATIONS

AGILI-C™ should not be implanted in subjects with the following conditions:

Active or latent, bone or joint infection at the surgical site; Active infection elsewhere in the body; Neuropathic joint; Hypersensitive, allergic, or intolerance of materials containing calcium carbonate or coral derivatives; Critical limb ischemia; Any known tumor of the knee area; Severe Osteoarthritis of the index knee, defined as grade 4 according to the Kellgren-Lawrence Grading; Uncontained lesion - lack of vital bone wall, at least 2mm thick, surrounding the implantation site; Subchondral bone defect or bone cyst depth deeper than 8mm; Inability to position the implant 2mm recessed relative to the articular surface; Osteochondral or cystic lesions larger than what the implant can cover; Implantation inside avascular necrosis.

WARNINGS

The safety and effectiveness of the AGILI-C™ Implant has not been established in patients with the following conditions: Morbid obesity (BMI >35); Known insulin dependent diabetes mellitus; Immunocompromised patients; including patients receiving a previous intra-articular steroid injection within the last 1 month; Systemic conditions affecting wound healing; Systemic bone disorder, such as but not limited to, osteoporosis and osteogenesis imperfecta; Chemotherapy during the past 12 months; Ligamentous instability; Significant malalignment; Total or subtotal meniscectomy or lack of functional meniscus; Inflammatory arthropathy or crystal-deposition arthropathy; Skeletally immature; Inability to refrain from contact sports/high-impact activities during recovery period; Noncompliance due to major psychiatric disorder, alcohol or drug abuse; Skin conditions within the field of surgery. The implant is not indicated for treatment in Patellar cartilage and osteochondral defects or for use in other joints.

RISKS AND SIDE EFFECTS

As with any surgical procedure, there are risks you should be aware of to help make your decision. The most common risks that occur with the AGILI-C™ implant include increased transient or chronic pain of the operated joint, increased swelling and/or effusion of the operated joint, decreased range of motion, hemarthrosis and contusion.

In addition to the risks above, there are other risks that may occur. For full product information, including indications for use, contraindications, precautions, warnings and adverse events, please consult the product’s applicable Instructions for Use (IFU) prior to use.

Disclaimers

*At 2- and 4-year follow-up.

**Compared to the surgical standard of care (microfracture or debridement) at 4-year follow-up.

***Over 2 and 4 yr follow-up; standard of care = microfracture or debridement.

****Information accurate at the time of writing, January 2026.

Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Smith+Nephew representative or distributor if you have questions about the availability of Smith+Nephew products in your area. For detailed product information, including indications for use, contraindications, precautions and warnings, please consult the product’s applicable Instructions for Use (IFU) prior to use.

Citations
  1. Altschuler, et al. AJSM 2023: 51(4), 957-967
  2. Conte P, et al. Int Orthop. 2024;48(12):3117–3126.
  3. Kon E, et al. J Orthop Surg Res. 2015 May 28;10:81.
  4. Kon E, et al. Am J Sports Med. 2021 Mar;49(3):588-598.
  5. Kon E, et al. Injury. 2016;47 Suppl 6:S27-S32.
  6. CartiHeal 2009. Indications for Use: Agili-C implant.
  7. Altschuler Z, et al. American Journal of Sports Medicine, 2026.

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