When cartilage repair is put to the test: five-year CARTIHEAL◊ AGILI-C◊ Cartilage Repair Implant outcomes
Key takeaways:1
Five-year randomized controlled trial data (RCT) provides high-level evidence in knee cartilage repair
The CARTIHEAL AGILI-C Cartilage Repair Implant demonstrated sustained improvements in pain, function, and quality of life (QoL) compared with surgical standard of care (SSOC; microfracture or debridement)
A greater proportion of patients achieved clinically meaningful improvement, with fewer patients progressing to joint‑replacing procedures compared with SSOC
Treatment with the CARTIHEAL Implant was associated with a significantly lower risk of knee replacement or osteotomy compared to SSOC (p=0.008)
Outcomes were consistent in patients with and without early osteoarthritis
So what do these five-year data mean when you’re choosing a treatment strategy?
Sustained improvements in pain and function, reduced need for intra-articular injections and reintervention, and a lower progression to knee replacement or osteotomy support the CARTIHEAL Implant as a joint-preserving option earlier in the treatment pathway, including for patients with mild-to-moderate osteoarthritis.
What is the challenge in cartilage repair?
In cartilage repair, early outcomes often tell us whether a treatment can work. Important considerations for surgeons and patients alike are whether those benefits are still present years later.
Despite advances in the field, arthroscopic procedures such as debridement and microfracture remain widely used.2,4 They are familiar, accessible, and can offer short-term symptom relief. However, their ability to deliver durable cartilage repair, particularly in patients with larger lesions or early osteoarthritis, has been inconsistent, with outcomes often declining over time.3
The CARTIHEAL Implant was developed as a joint-preserving solution designed to support repair of both cartilage and subchondral bone. Five-year RCT data now provide an opportunity to assess whether earlier clinical results at two years with the CARTIHEAL Implant translate into sustained improvements: not just in carefully selected patients, but in a population that reflects everyday surgical practice. This study included, but was not limited to, patients with mild-to-moderate osteoarthritis, presence of multiple lesions, lesions up to 7cm2, patients up to 75 years of age, those undergoing concomitant procedures, and patients with malalignment of less than 8° (varus/valgus).1
Study at a glance:
Primary endpoint: change in overall Knee injury and Osteoarthritis Outcome Score (KOOS) at five years
Secondary endpoints: KOOS subscales, responder rate (≥30-point improvement in KOOS), treatment failure (reintervention or intra-articular injection), and safety
These five-year results build on earlier CARTIHEAL Implant evidence:
Sustained improvement in knee function at five years1
Patients in both groups began with similar KOOS scores. Over time, however, outcomes diverged. At five years, patients treated with the CARTIHEAL Implant achieved a clinically meaningful improvement in overall KOOS versus SSOC, with a 22.6-point greater improvement in mean improvement from baseline (95% CI, 16.6–28.7). Higher overall KOOS scores were observed at every postoperative time point through five years. In practical terms, this meant patients treated with the CARTIHEAL Implant didn’t just improve early: functional gains were still evident at a time point when outcomes with standard approaches often decline.
Figure: primary endpoint changes in KOOS overall from baseline to 60 months
Pain improvements with the CARTIHEAL Implant were maintained through five years, not just achieved early1
Pain relief remains a key driver of treatment choice in cartilage repair. In this trial, patients treated with the CARTIHEAL Implant experienced approximately twice the magnitude of pain improvement compared with SSOC, with between-group differences maintained at five‑year follow‑up (p<0.001).
These symptom improvements were accompanied by meaningful gains in knee-related quality of life, including day-to-day function and participation in sport and recreation (p<0.001). Knee-related QoL and function in sport and recreation have previously been rated as of the highest importance to patients.7
Compared with SSOC, the CARTIHEAL Implant was also associated with fewer pain-related adverse events (22.2% vs 48.8%) and a reduced need for intra-articular injections (6.6% vs 27.4%; p<0.001), consistent with a sustained reduction in pain burden over time.
Preserving the joint: reduced progression to further surgery1
Beyond symptom relief, preserving the native joint is a critical long-term goal, particularly for younger or middle-aged patients seeking to delay or avoid more invasive surgery.
At five years, progression to knee replacement or osteotomy was significantly lower with the CARTIHEAL Implant than with SSOC (1.8% vs 9.5%; p=0.008). Overall treatment failure, defined as surgery and/or intra-articular injection, was also lower with the CARTIHEAL Implant (15.0% vs 35.7%), supporting cartilage repair with the CARTIHEAL Implant as a strategy that may help maintain joint function and reduce the likelihood of major downstream procedures.
What does this mean for patients with mild-to-moderate osteoarthritis?1
Mild-to-moderate osteoarthritis (Kellgren-Lawrence grades 2–3) is often viewed as a gray zone for cartilage repair. In this study, however, at five years, KOOS responder rates among patients with mild-to-moderate osteoarthritis were 74.6% with the CARTIHEAL Implant versus 36.2% with SSOC.
Treatment failure and reintervention rates were markedly lower with the CARTIHEAL Implant (13.2% vs 40.7%; p<0.001). No patients who received the CARTIHEAL Implant experienced progression of osteoarthritis during the study, compared with four patients in the SSOC group.
In a preplanned subanalysis of the CARTIHEAL Implant patients, patients with mild-to-moderate osteoarthritis experienced sustained outcome improvements that closely mirrored those seen in patients without osteoarthritis.
Are short-term improvements still enough, or should five-year outcomes now guide cartilage repair decisions?
About the CARTIHEAL Implant
Derived from a naturally occurring calcium carbonate known as aragonite. Repair knee cartilage, restore damaged bone, and relieve pain;1,6,9 and has been shown to be largely resorbed by the body within 18 months.8,9,10
This information is for educational and informational purposes only and may not be appropriate for all jurisdictions. This information does not constitute and is not intended to serve as medical advice. Smith+Nephew does not provide medical advice. It is the treating health care provider’s responsibility to determine the best course of treatment for their patient based upon their professional medical judgment. For detailed information, including indications for use, contraindications, effects, precautions and warnings, please consult the product’s Instructions for Use (IFU) prior to use.
References
1) Altschuler N, et al. Am J Sports Med. 2026. Published online April 16, 2026. doi:10.1177/03635465261437781
2) McCormick F, et al. Arthroscopy. 2014;30(2):222–230.
3) Vaish A, Vaishya R. J Arthrosc Surg Sports Med. 2024;5:1–12.
4) Thakkar AP, et al. J Cartilage Joint Preserv. 2024;4(4):100219.
5) Altschuler, et al. Am J Sports Med. 2023;51(4):957–967.
6) Conte P, et al. Int Orthop. 2024;48(12):3117–3126.
7) Hambly K, et al. Am J Sports Med. 2008;36(9):1695–70.
8) Kon E, et al. J Orthop Surg Res. 2015: 28;10:81.
9) Kon E, et al. Am J Sports Med. 2021;49(3):588–598.
10) Kon E, et al. Injury. 2016;47 Suppl 6:S27–S32.
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