How the CARTIHEAL◊ Implant performed in 4-year data [in 3 key highlights]

Introduction

Four years of prospective, randomized controlled trial data in cartilage repair does not happen often, but these results are hard to ignore. Its purpose was to assess how Smith+Nephew’s CARTIHEAL^◊ AGILI-C^◊ Implant compared to the current surgical standard of care over a meaningful post-operative period, and it’s safe to say that objective was met.

When an alternative method of repair enters the conversation, two questions come to the fore: how does it perform over the long term, and how does it compare to current methods? In a direct comparison to microfracture and debridement—thought to be the current surgical standard—these results at 4-year follow-up1 clearly and confidently answer both questions.

Returning meaningful improvements in function scores, patient-reported outcome measures, and a compelling impact on the risk of progressing to total knee arthroplasty or osteotomy,*¹ they convey a clear message: the CARTIHEAL Implant is not simply another solution to consider, but an evidence-driven shift in the cartilage repair conversation.

Let’s break it down to find out why.

KOOS scores show more than pain relief

Knee Injury and Osteoarthritis Outcome (KOOS) capture the broader impact on overall experience and quality of life, so when patients treated with the CARTIHEAL Implant showed significantly greater improvements in overall KOOS scores at four years*¹ it instantly highlights a notable lift in the felt experience of patients. Furthermore, these improvements were recorded irrespective of the location of the lesion or, crucially, the presence of osteoarthritis (Kellgren-Lawrence 0-3).¹

If some cartilage repair methods face criticism for short-term wins that fade over time, this evidence is very encouraging in demonstrating the CARTIHEAL Implant’s ability to defy that trend.

Digging deeper into PROMs data

Looking beyond the headline KOOS scores, the results become even more favorable. Tracking a broader set of patient-reported outcome measures revealed that patients consistently reported significantly greater improvements across all lesion locations.¹

 Pain, knee function, and the return to sport all improved, as shown in International Knee Documentation Committee (IKDC) scores, and shown to be significantly higher for patients treated with the CARTIHEAL Implant.*¹

Factors like cartilage fill can be objectively measured in post-operative assessment, but what patients truly care about is their ability to walk, run and live without pain or discomfort. To that end, these 4-year results make a compelling case when stacked against the current standard (particularly for patients).¹

Reducing the risk of knee replacement or osteotomy

Perhaps the most striking conclusion we can draw from this study is concerning longer-term clinical implications. If cartilage repair has been traditionally viewed as a stopgap, potentially to buy time before knee replacement or osteotomy down the line, then this evidence is very encouraging.

Demonstrating an 87% reduction in the risk of total knee arthroplasty or osteotomy at four years,¹ this sets the CARTIHEAL Implant apart from standard repair interventions. Not just slightly, but by a substantial margin, as an evidence-based intervention that can change the trajectory of knee damage.

Could this evidence inspire more patients to consider the CARTIHEAL Implant as a treatment option?

A look at other clinical evidence for the CARTIHEAL Implant

Aside from the headline takeaways of this study, additional observations made throughout the 48-month follow-up period add strength to the overall narrative.

Osteoarthritis

Mentioned before, but worth reinforcing, is the fact that the absence or presence of osteoarthritis (KL 0-3) did not affect the performance of the CARTIHEAL Implant.¹

Cartilage fill

Patients with the CARTIHEAL Implant had significantly superior imaging outcomes at 24 months, showing more than 75% defect fill in:

• 93.9% of condylar defects (vs 39% for the surgical standard)^*1
• 97.6% in mixed lesions (vs 18.8% for the surgical standard)^*1
• 62.5% in trochlear defects (vs 18.2% for the surgical standard)^*1

Responder rate

Shown to be significantly higher in all lesion locations at 12, 36 and 48 months for patients treated with the CARTIHEAL Implant.*¹

The compounding effect of these additional observations is that the CARTIHEAL Implant patients consistently benefitted across all possible measures, across the board.

How the study was performed

The strength of any data hinges on the detail of how those outcomes were set up, assessed and measured. As a multi-center randomized controlled trial using a diverse patient population with condyle defects, trochlear defects or mixed lesions, this is gold standard, level 1 data.

Based on 247 patients, including patients with concurrent mild to moderate osteoarthritis (KL 0-3), fully randomized to receive either the CARTIHEAL Implant (164 patients) or the surgical standard of care (83 patients).^1,2 Following patients for four years with defined and clear endpoints, the rigor of this data provides a solid base of analysis for surgeons, payers and regulators alike.

How does the CARTIHEAL Implant work?

These four-year results are a key aspect of the story when assessing an alternative approach to cartilage repair. Another key aspect is understanding how the CARTIHEAL Implant achieves these results.

Comprised of biphasic aragonite, it has a similar porosity to cancellous bone, helping it to restore bone at the subchondral level (called the bone phase). A modified porosity, achieved with drill channels, then repairs cartilage at the level of existing healthy cartilage (called the cartilage phase).^2-4

The ability to address both the cartilage and the subchondral bone is what differentiates the technology from other methods of repair, shown in histological images to create high levels of type 2 collagen and proteoglycan.³

What’s more, removing the need for cell harvesting or donor tissue and requiring only one procedure (as opposed to some two-stage procedure methods), it adds up to a convenient and off-the-shelf treatment option that can be implanted with or without concomitant procedures or the presence of mild to moderate osteoarthritis (KL 0-3).

Watch Dr Sabrina Strickland demonstrate the CARTIHEAL Implant technique on VuMedi here.

Key takeaways of 4-year data

The conclusion of this RCT is relatively straightforward. Patients treated with the CARTIHEAL Implant experienced better results than those treated with microfracture or debridement, even if they had mild to moderate osteoarthritis.¹ It’s that simple. The study showed that patients do better, they feel better, and they are more likely to avoid more intense knee procedures in the future.*¹

Cartilage repair has been a field of both promise and frustration, but these results feel more rigorous and real (and long-term). The CARTIHEAL Implant works…and it has data to prove it.

With 5-year data on the horizon, this is a watershed moment for surgeons to consider. Does the current surgical standard hold, or are these results too difficult to ignore?

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*Compared to the surgical standard of care = microfracture and debridement. Significantly higher KOOS scores – all p<0.05. Significantly higher IKDC scores –p=0.009 at 12 months p=0.076 at 36 months, p=0.023 at 48 months across trochlear and condyle lesions. Cartilage fill - 93.9% of condylar defects (vs 39.0%; p<0.0001), 62.5% in trochlear defects (vs 18.2%; p=0.012) and 97.6% in mixed lesions (vs 18.8%; p<0.0001). Significantly higher responder rate in all lesions – all p<0.004.

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