KNEE

Chondral and osteochondral knee repair​

Treat knee cartilage lesions and osteochondral defects in a single-stage procedure, even in the presence of mild to moderate osteoarthritis (Kellgren-Lawrence 0-3),1,2 with the porous, biocompatible CARTIHEAL◊ AGILI-C◊ Cartilage Repair Implant; shown to be clinically superior to the current surgical standard of care in level 1 clinical data.*1,2

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Repair cartilage, restore bone, relieve pain1-3​

The need for knee cartilage repair is expected to grow,4 with articular cartilage injuries already observed in 60-66% of knee arthroscopies5-7 and knee cartilage repair procedures projected to increase through 2031.4 However, conventional approaches currently result in an average 1 in 4 patients not returning to sport.**8 Furthermore, many patients treated with microfracture return to the operating room.***9

As an alternative to conventional surgical repair methods, the CARTIHEAL Implant is a naturally occurring, biomaterial scaffold that helps repair cartilage and restore bone;1-3,10-14 shown to result in a significantly greater improvement in overall KOOS scores*1,2 and reduced the risk of total knee arthroplasty or osteotomy by 87%.****1

Designed for off-the-shelf convenience, the procedure can be carried out in a single stage without any additional preparation of the implant.

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Click the link below to learn more about the CARTIHEAL Implant.

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Suitable for use across a range of indications​

The CARTIHEAL Implant can be used to support a broad range of chondral and osteochondral repair indications, ranging from skeletally mature patients to older patients.

Defect types and application




Key features​

Backed by level 1 clinical data,1,2 the CARTIHEAL Implant offers surgeons numerous clinical and procedural advantages.


Step 1: Position and drill



Position and verify the aligner perpendicular to the articular surface. Attach the K-wire to a drill and thread through the aligner, and drill until the indicator line is reached. After releasing the K-wire, the aligner is removed. After attaching the drill bit to a drill, thread it into the positioned drill sleeve and over the K-wire until it reaches a stop.

Download the full surgical technique guidance here​



Step 2: Ream and shape



After connecting the quick-connect handle, insert the reamer over the K-wire and manually rotate clockwise until the indicator line is no longer visible from all sides. With the K-wire still in place, remove the reamer and rinse with saline. ​

Connect the shaper to the quick-connect handle and insert the shaper over the K-wire. Manually rotate clockwise until the indicator line is no longer visible and rinse with saline to remove debris.





Step 3: Trim peripheral cartilage​



Remove the K-wire, then use the cartilage cutter or a scalpel to trim the peripheral cartilage to provide smooth edges and avoid tissue entrapment during CARTIHEAL Implant insertion.





Step 4: Insert the CARTIHEAL Implant​



Firmly insert the CARTIHEAL Implant using your thumb until the implant is flush with the articular cartilage. Using the tamper, gently push the implant into its final position 2mm below the surface of the articular cartilage. When using multiple implants, maintain a bone bridge of at least 5mm between implants to avoid impingement. ​

Please refer to the full surgical technique guide for full details and precautions.​





CARTIHEAL Implant mechanism of action

After implantation, the CARTIHEAL Implant has a distinct, two-phase mode of action. ​

In the bone phase, mesenchymal stem cells (MSCs) adhere and differentiate into osteogenic cells, which form new bone (demonstrated in vitro).12 ​

In the cartilage phase, a modified porosity helps MSCs differentiate into chondrocytes. On the surface, chondrocyte cells migrate from the surrounding native cartilage and form new cartilage (demonstrated in vitro and in vivo).10,14,16,17

CARTIHEAL AGILI-C MOA GIF

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Surgical videos​



Reference material​

Products



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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

* Compared to the surgical standard of care (microfracture or debridement) at 2- and 4-year follow-up.

** Average return to sport demonstrated in a meta-analysis examining patients treated with microfracture, osteochondral allograft transplantation, autologous chondrocyte implantation and osteochondral autograft transfer. Performance of specific procedure may vary.

*** ~35% and ~40% required additional procedures related to the articular cartilage 4 and 10 years after microfracture

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

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. Conte P, et al. Int Orthop. 2024;48(12):3117–3126.
  2. Altschuler N, et al. Am J Sports Med. 2023;51(4):957-967.
  3. Kon E, et al. Am J Sports Med. 2021;49(3):588-598.
  4. iHealthcareAnalyst, April 2024. Global Knee Repair Market Analysis. Available here.
  5. Curl WW, et al. Arthroscopy. 1997;13(4):456-60.
  6. Aroen A, et al. Am J Sports Med. 2004;32:211-5.
  7. Widuchowski W, et al. Knee. 2007;14:177-82.
  8. Krych J, et al. Knee Surg Sports Traumatol Arthrosc, 2017 25(10):3186-3196.
  9. Weber AE, et al. Orthop. J sports Med, 2018;6(2).
  10. Kon E, et al. J Orthop Surg Res. 2015;10:81.
  11. Kon E, et al. Injury. 2016;47 Suppl 6:S27-S32.
  12. Matta C, et al. Differentiation. 2019;107:24-34.
  13. Kon E, et al. Knee Surg Sports Traumatol Arthrosc. 2014;22(6):1452-1464.
  14. Chubinskaya S. Knee Surg Sports Traumatol Arthrosc. 2019;27(6):1953-1964.
  15. Smith+Nephew. CARTIHEAL Instructions for Use (IFU).
  16. Li S, et al. Biomater Sci. 2020;8(16):4458-4466.
  17. Han Y, et al. Front Bioeng Biotechnol. 2021;9:629270.

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