Study: Smith+Nephew’s Cartilage Repair Implant Provides Better Pain Relief

Smith+Nephew’s CARTIHEAL AGILI-C Cartilage Repair implant is superior to standard care methods at relieving knee and osteoarthritis pain, a study has concluded.

Published in the American Journal of Sports Medicine (AJSM), the multicenter, randomized controlled trial showed higher overall Knee injury and Osteoarthritis Outcome Scores (KOOS) with CARTIHEAL compared with the surgical care standard* for all time points out to 60 months.^1,2

• Superior pain relief: Patients treated with the CARTIHEAL Implant reported significantly better knee pain relief and quality-of-life improvements over a five-year period.¹
• Superior functional gains: Patients treated with the CARTIHEAL Implant reported superior improvements in performing activities related to daily living, sport and recreation at two, four, and five years.^1,2
• Patients with/without osteoarthritis (OA): Equal clinical outcomes were found in OA and non-OA patients receiving the CARTIHEAL Implant.^1,2

“Having been involved with CARTIHEAL from the initial trial design, through patient enrollment, and now in daily clinical use, I’m thrilled by the five-year outcomes. Notably, CARTIHEAL patients had twice the reduction in pain scores compared to standard care,” said Dr. Andreas Gomoll, professor of Orthopedic Surgery at Weill-Cornell Medical School and attending orthopedic surgeon at the Hospital for Special Surgery in New York. “What excites me even more is that these outcomes were comparable for both patients with and without osteoarthritis. This represents a vital new option for those in the osteoarthritis treatment gap where cartilage is too damaged for standard repair but not enough for joint replacement. Historically, these patients relied on non-surgical methods with mixed success. Now, we have a durable solution to restore function and quality of life.”

Smith+Nephew’s U.S. Food and Drug Administration-approved CARTIHEAL Implant’s broad indication allows physicians to treat patients who previously may not have had access. The implant received a Category I Current Procedural Terminology (CPT) code for procedures that will take effect Jan. 1, 2027.

“Patients need an off the shelf scaffold with strong clinical evidence—one that can effectively treat both chondral and osteochondral defects, even in those with mild to moderate osteoarthritis. These new five-year results further validate the promise of the CARTIHEAL Implant,” said Professor Elizaveta Kon from Humanitas Research Hospital. “They show we can finally offer a reliable, evidence-backed solution to a large patient population that, in many cases, has had limited treatment options. Seeing such durable outcomes is truly exciting.”

The CARTIHEAL Implant is commercially available in the United States, including Puerto Rico. Composed of aragonite, a naturally occurring calcium carbonate acting as a biphasic scaffold, the implant repairs cartilage and restores subchondral bone.^3-7

Smith+Nephew is a portfolio medical technology business focused on the repair, regeneration, and replacement of soft and hard tissue. Its 17,000 employees help deliver this mission through the company’s existing products, and the invention and application of new technologies across three global business units of Orthopaedics, Sports Medicine & ENT, and Advanced Wound Management. Founded in Hull, United Kingdom, in 1856, Smith+Nephew currently operates in about 100 countries, and generated $6.2 billion in 2025 sales. Smith+Nephew is a constituent of the FTSE100.

* compared to debridement or microfracture 

References
¹ Altschuler N ZK, Di Matteo B, et al. Five-Year Follow-up of a Multicenter Randomized Controlled Trial Comparing an Aragonite-Based Scaffold with Microfracture and Debridement for Chondral and Osteochondral Knee Lesions. Am J Sports Med 2026.
² Conte P, Anzillotti G, Crawford DC, et al. Differential analysis of the impact of lesions’ location on clinical and radiological outcomes after the implantation of a novel aragonite-based scaffold to treat knee cartilage defects. Int Orthop. 2024;48(12):3117-3126
³ Altschuler N, Zaslav KR, Di Matteo B, et al. Aragonite-Based Scaffold Versus Microfracture and Debridement for the Treatment of Knee Chondral and Osteochondral Lesions: Results of a Multicenter Randomized Controlled Trial. Am J Sports Med. 2023;51(4):957-967. doi:10.1177/03635465231151252
⁴ Kon E, Di Matteo B, Verdonk P, et al. Aragonite-Based Scaffold for the Treatment of Joint Surface Lesions in Mild to Moderate Osteoarthritic Knees: Results of a 2-Year Multicenter Prospective Study. Am J Sports Med. 2021;49(3):588-598. doi:10.1177/0363546520981750
⁵ Kon E, Filardo G, Shani J, et al. Osteochondral regeneration with a novel aragonite-hyaluronate biphasic scaffold: up to 12-month follow-up study in a goat model. J Orthop Surg Res. 2015;10:81. Published 2015 May 28. doi:10.1186/s13018-015-0211-y
⁶ Matta C, et al. Differentiation.2019;107:24-34.
⁷ Chubinskaya S, et al. Knee Surg Sports Traumatol Arthrosc. 2019;27(6):1953-1964.