Fewer re-tears, greater value: The REGENETEN◊ Bioinductive Implant has been shown to enhance rotator cuff repair cost-effectiveness1
Summary:
A randomised controlled trial (RCT) showed augmentation with the REGENETEN Implant, compared with standard medium- to large-sized full-thickness rotator cuff tear repair (RCR), reduced the rate of post-operative tendon re-tear from about 1 in 4 patients (26%) to 1 in 12 (8%) at one-year follow-up, without increasing complications.2 Furthermore, cost-effectiveness modelling demonstrated augmentation with the REGENETEN Implant was a cost-effective treatment strategy to reduce tears compared to RCR alone.1
Despite higher initial procedure costs, the average 10-year total costs were lower with the REGENETEN Implant ($49,240) than with RCR alone ($56,358), saving approximately $7,119 per patient.1
Patients treated with RCR plus the REGENETEN Implant gained an average of 5.6 QALYs versus 4.3 QALYs with RCR alone, indicating an improved long-term health-related quality of life.1
A QALY is a measurement of the value of health; it combines how good your health is over a specific time-period. One QALY is one year in perfect health. In this study, it was estimated patients who received augmentation with the REGENETEN Implant gained 1.3 years of perfect health compared to patients who received RCR alone.
Why re-tears matter
Rotator cuff tears are common in older, active patients and often progress to surgery when symptoms persist despite conservative care.3-4 Even with modern arthroscopic techniques, re-tear rates of 20–30% have been reported in medium-to-large tears, particularly in patients with poor tissue quality or adverse prognostic factors such as fatty infiltration, retraction, or high physical demands.2,5 These re-tears drive downstream costs through further imaging, clinic visits and revision procedures such as reverse shoulder arthroplasty.6-7
How the REGENETEN Implant changes the pathway
The REGENETEN Bioinductive Implant is a type I collagen scaffold which can be used as either a standalone treatment or an augmentation to repair rotator cuff tears, to aid tendon healing. REGENETEN Implant augmentation reduced re-tear rates from 26% with RCR alone to 8% (p=0.01) at one year, without increasing complications. Evidence from MRI, biopsy and histology suggests that the implant becomes infiltrated with tendon-derived cells, integrates into the native tissue, improves tendon quality, and reduces re-tear rates.2,3,8-13
What the cost-effectiveness model did
A 10-year health-economic (Markov) model followed representative adults with symptomatic, repairable, medium-to-large posterosuperior rotator cuff tear undergoing either RCR alone or RCR with the REGENETEN Implant. The model incorporated re-tear probabilities at one year from the randomised trial, subsequent progression, revision with reverse shoulder arthroplasty, complications, US payer costs and utility values for intact versus torn cuffs, with both costs and QALYs discounted at 3% per year. Monte Carlo microsimulation (1000 patients) and probabilistic sensitivity analysis allowed key inputs (e.g., costs, re-tear risks) to vary within clinically plausible ranges, testing the robustness of the conclusions under uncertainty.1
Key numerical results
Over the simulated 10-years, RCR with the REGENETEN Implant predicted higher health benefits and lower mean total costs than RCR alone:1
On average, patients receiving augmentation would accrue 5.6 QALYs versus 4.3 QALYs with RCR alone, while total mean costs were predicted to be $49,240 with RCR and the REGENETEN Implant and $56,358 with RCR alone, resulting in a potential $7,119 saving in favour of augmentation with the REGENETEN Implant.1
Because augmentation was both more effective and less costly, it was classified as a dominant strategy and was preferred in 100% of simulations at all willingness-to-pay (WTP) thresholds assessed i.e. whether the benefits of a treatment are worth the cost.1
Table: Summary of key modelled outcomes (10-year horizon)
*Dominated - i.e., Standard RCR was demonstrated to be more costly and less effective
CI = confidence interval, SD = standard deviation, WTP = willingness-to-pay
Robustness and thresholds
Probabilistic sensitivity analysis, i.e., testing how reliable a study’s results are by repeatedly recalculating them using many different possible values for uncertain inputs to see if the overall conclusion changes, showed a consistent shift toward lower cost and higher QALYs in the REGENETEN Implant arm across all simulated scenarios.
Deterministic sensitivity analysis, i.e., adjusting one or more assumptions with varying inputs, i.e., re-tear rates, indicated that the re-tear risk after augmented repair would have to rise above 22.7%, nearly triple the base-case rate, for standard RCR to become more cost-effective at a $50,000 willingness to pay threshold.1
Clinical context
The model supports the use of the REGENETEN Implant in symptomatic, repairable medium-to-large full-thickness posterosuperior tears, a population in whom re-tear risk and downstream costs are substantial.1
Key takeaways1
Despite higher upfront procedure costs, the mean 10‑year total costs were lower with the REGENETEN Implant ($49,240) than with RCR alone ($56,358), an approximate saving of $7,119 per patient
Patients treated with RCR plus REGENETEN accrued 5.6 QALYs on average versus 4.3 QALYs with RCR alone, reflecting better long-term health-related quality of life
The probability that RCR with the REGENETEN Implant was the most cost-effective option was 100% across all willingness-to-pay thresholds evaluated
The study supports incorporating RCR augmented with the REGENETEN Implant into clinical practice for appropriate patients as a value-based option that can reduce failure-related costs.1
The REGENETEN Bioinductive Implant: revolutionizing rotator cuff repair
The REGENETEN Bioinductive Implant is a highly porous scaffold made from purified type I collagen fibers.10 Following fixation, it induces the formation of ~2mm of tendon-like tissue and is absorbed by the body within 6 months.11–13
The REGENETEN◊ Bioinductive Implant is only available from Smith+Nephew
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 be 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
Hurley ET, et al. Arthroscopy. Published online February 2026 https://doi.org/10.1002/arj.70000
Ruiz Ibán MA, et al. Arthroscopy. 2024;40(6):1760-1773.
Hinsley et al, et al. BMJ Open. 2022;12(9):e059175.
Davey MS, et al. Arthroscopy. 2023;39:452-458.
Hein et al. Arthroscopy. 2015;31(11)2274–2281.
Young BL, et al. JSES Rev Rep Tech. 2023;3:18–23.
Makhni EC, et al. Arthroscopy. 2016;32:1771–1780.
Camacho-Chacón JA, et al. J Exp Orthop. 2022;9(1):53.
Camacho Chacón JA, et al. J Shoulder Elbow Surg. 2024;33(9):1894–1904.
Bokor DJ, et al. Muscles Ligaments Tendons J. 2016;6(1):16–25.
Schlegel TF, et al. J Shoulder Elbow Surg. 2021;30(8);1938–1948.
Van Kampen C, et al. Muscles Ligaments Tendons J. 2013;3(3):229–235.
Arnoczky SP, et al. Arthroscopy. 2017;33(2):278–283.
