Clinical Studies

As a company, we are continuing to support head-to-head, direct comparative studies against many implant designs, and we are supporting multiple studies in progress that are assessing various patient outcomes measures.

You can find the latest information on clinical studies on Conformis implants on ClinicalTrials.gov.

Following is a list of published papers on Conformis implants:

Weber P, Beck M, Klug M, Klug A, Klug A, Glowalla C, Gollwitzer H. Survival of Patient-Specific Unicondylar Knee Replacement. J Pers Med. 2023 Apr 14;13(4):665. doi: 10.3390/jpm13040665. PMID: 37109051; PMCID: PMC10144963.
Survival of Patient-Specific Unicondylar Knee Replacement – PubMed (nih.gov)

Schroeder, Lennart MD1,a; Dunaway, Andrew DO2; Dunaway, Daniel MD3 A Comparison of Clinical Outcomes and Implant Preference of Patients with Bilateral TKA, JBJS Reviews: February 2022 – Volume 10 – Issue 2 – e20.00182 doi: 10.2106/JBJS.RVW.20.00182
https://journals.lww.com/jbjsreviews/Abstract/2022/02000/A_Comparison_of_Clinical_Outcomes_and_Implant.3.aspx

Zeh, Alexander; Gehler, Valentina; Gutteck, Natalia; Beckmann, Johannes; Brill, Richard; Wohlrab, David. Superior Clinical Results and Higher Satisfaction after Customized Compared with Conventional TKA, Acta Orthopaedica Belgica: December 2021 – Volume 87 – Issue 4 https://doi.org/10.52628/87.4.10

Schroeder, Lennart MD1,a,*; Pumilia, Cyrus Anthony MD2,*; Sarpong, Nana O. MD, MBA3; Martin, Gregory MD, FAAOS2,4,5 Patient Satisfaction, Functional Outcomes, and Implant Survivorship in Patients Undergoing Customized Cruciate-Retaining TKA, JBJS Reviews: September 2021 – Volume 9 – Issue 9 – p e20.00074 doi: 10.2106/JBJS.RVW.20.00074
https://journals.lww.com/jbjsreviews/Abstract/2021/09000/Patient_Satisfaction,_Functional_Outcomes,_and.8.aspx?context=LatestArticles

Fernando, N., Chancellor, A., Manner, P. (2021) “Custom-designed total knee arthroplasty is cost-effective in comparison to a standard implant”. 2021 Proceedings of Orthopaedic Research Society, Paper 0980. Presented at the ORS 2021 Annual Meeting. https://www.ors.org/Transactions/67/980.pdf

Reimann, P., Brucker, M., Arbab, D., & Lüring, C. (2019). “Patient satisfaction – A comparison between patient-specific implants and conventional total knee arthroplasty”. Journal of orthopaedics, 16(3), May-June 2019, pages 273–277. https://doi.org/10.1016/j.jor.2019.03.020

Schroeder, L., Neginhal, V., Kurtz, W.B. (2019) “Patient Satisfaction, Functional Outcomes and Survivorship in Patients with a Customized Posterior-stabilized Total Knee Arthroplasty”. Orthopaedic Proceedings Vol. 101-B, No. SUPP_4. Published Online: 8 Apr 2019
https://online.boneandjoint.org.uk/doi/abs/10.1302/1358-992X.2019.4.046

Meier, M., Zingde, S., Steinert, A., Kurtz, W., Koeck, F., & Beckmann, J. (2019). What is the possible impact of high variability of distal femoral geometry on TKA? A CT data analysis of 24,042 knees. Clinical Orthopaedics and Related Research^®, 477(3), 561-570.  https://journals.lww.com/clinorthop/Abstract/2019/03000/What_Is_the_Possible_Impact_of_High_Variability_of.18.aspx

Arbab, D., Reimann, P., Brucker, M., Bouillon, B., & Lüring, C. (2018). Alignment in total knee arthroplasty—A comparison of patient-specific implants with the conventional technique. The Knee, 25(5), 882-887. https://doi.org/10.1016/j.knee.2018.05.017

Kay, A. B., Kurtz, W. B., Martin, G. M., Huber, B. M., Tait, R. J., & Clyburn, T. A. (2018). Manipulation Rate Is Not Increased After Customized Total Knee Arthroplasty. Reconstructive Review, 8(1). (https://reconstructivereview.org/ojs/index.php/rr/article/view/210/262)

Schroeder, Lennart and Martin, Greg. “In Vivo Tibial Fit and Rotational Analysis of a Customized, Patient-Specific TKA versus Off-the-Shelf TKA.” The Journal of Knee Surgery Published Online: May 25, 2018 (https://www.thieme-connect.com/products/ejournals/html/10.1055/s-0038-1653966).

Levengood, Gary A., and Jack Dupee. “Accuracy of coronal plane mechanical alignment in a customized, individually made total knee replacement with patient-specific instrumentation.” The Journal of Knee Surgery Published Online: December 14, 2017 (doi: https://www.thieme-connect.com/products/ejournals/html/10.1055/s-0037-1608946).

Wang, Henry, Jonathan Foster, Natasha Franksen, Jill Estes, and Lindsey Rolston. “Gait analysis of patients with an off-the-shelf total knee replacement versus customized bi-compartmental knee replacement.” International Orthopaedics Published Online: September 4, 2017 (doi: https://doi.org/10.1007/s00264-017-3622-z).

Culler, Steven D., Greg M. Martin, and Alyssa Swearingen. “Comparison of adverse events rates and hospital cost between customized individually made implants and standard off-the-shelf implants for total knee arthroplasty.” Arthroplasty Today 3.4 (2017): 257–263.
http://www.arthroplastytoday.org/article/S2352-3441(17)30040-7/pdf
(doi: http://dx.doi.org/10.1016/j.artd.2017.05.001)

Zeller, Ian M., Adrija Sharma, William B. Kurtz, Mathew R. Anderle, and Richard D. Komistek. “Customized versus patient-sized cruciate retaining total knee arthroplasty: an in vivo kinematics study using mobile fluoroscopy.” The Journal of Arthroplasty 32.4 (2017): 1344-1350. http://dx.doi.org/10.1016/j.arth.2016.09.034

Steinert, Andre F., Johannes Beckmann, Boris Michael Holzapfel, Maximilian Rudert, and J. Arnholdt. “Bicompartmental individualized knee replacement: Use of patient-specific implants and instruments (iDuo^™).” Operative Orthopädie und Traumatologie 29.1 (2017): 51-58. https://doi.org/10.1007/s00064-017-0484-x

Jemmett, Peter, and Stuart Roy. “The iDuo Bi-compartmental knee replacement: our early experience.” Reconstructive Review 6.4 (2016): 13-17. http://dx.doi.org/10.15438/rr.6.4.149

Kurtz, William, John Slamin, and Scott Doody. “Bone Preservation in a Novel Patient Specific Total Knee Replacement.” Reconstructive Review 6.1 (2016): 23-29.
https://www.reconstructivereview.org/ojs/index.php/rr/article/view/133/164
http://dx.doi.org/10.15438/rr.6.1.133

Patil, Shantanu, Adam Bunn, William D. Bugbee, Clifford W. Colwell Jr., and Darryl D. D’Lima. “Patient-Specific Implants with Custom Cutting Blocks Better Approximate Natural Knee Kinematics than Standard TKA without Custom Cutting Blocks.” The Knee 22.6 (2015): 624–629. http://dx.doi.org/10.1016/j.knee.2015.08.002

Demange, Marco K., Arvind Von Keudell, Christian Probst, Hiroshi Yoshioka, and Andreas H. Gomoll. “Patient-Specific Implants for Lateral Unicompartmental Knee Arthroplasty.” International Orthopaedics 39.8 (2015): 1519-1526. https://doi.org/10.1007/s00264-015-2678-x

Schwarzkopf, Ran, Merrick Brodsky, Giancarlo A. Garcia, and Andreas H. Gomoll. “Surgical and Functional Outcomes in Patients Undergoing Total Knee Replacement with Patient-Specific Implants Compared with ‘‘Off-the-Shelf’’ Implants.” Orthopaedic Journal of Sports Medicine 3.7 (2015): 1-6.
http://journals.sagepub.com/doi/pdf/10.1177/2325967115590379
https://doi.org/10.1177/2325967115590379

Ivie, Conrad B., Patrick J. Probst, Amrit K. Bal, James T. Stannard, Brett D. Crist, and B. Sonny Bal. “Improved Radiographic Outcomes with Patient-Specific Total Knee Replacement.” The Journal of Arthroplasty 29.11 (2014): 2100-2103. https://doi.org/10.1016/j.arth.2014.06.024

Carpenter, Dylan, Rebecca Holmberg, Marc Quartulli, and C. Lowry Barnes. “Tibial Plateau Coverage in UKA: a Comparison of Patient Specific and Off-the-Shelf Implants.” The Journal of Arthroplasty 29.9 (2014): 1694-1698. https://doi.org/10.1016/j.arth.2014.03.026

Nunley, Ryan M., Denis Nam, Staci R. Johnson, and C. Lowry Barnes. “Extreme Variability in Posterior Slope of the Proximal Tibia: Measurements on 2,395 CT Scans of Patients Undergoing UKA?” The Journal of Arthroplasty 28.8 (2014): 1677-1680.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4174602/pdf/nihms-618337.pdf
https://doi.org/10.1016/j.arth.2014.03.024

Palumbo, Brian T., Joshua Lindsey, and Wolfgang Fitz. “Patient-specific Total Knee Arthroplasty: A Novel Technique and Implant.” Techniques in Knee Surgery 11.4 (2012): 182-188. *Journal has ceased publication and is not available online currently.

Schwechter, Evan M., and Wolfgang Fitz. “Design Rationale for Customized TKA: A New Idea or Revisiting the Past?” Current Reviews in Musculoskeletal Medicine 5.4 (2012): 303–308.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3702755/pdf/12178_2012_Article_9143.pdf
https://doi.org/10.1007/s12178-012-9143-x

Sinha, Raj K. “The Use of Customized TKA Implants for Increased Efficiency in the OR.” Current Reviews in Musculoskeletal Medicine 5.4 (2012): 296–302.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3702753/pdf/12178_2012_Article_9140.pdf
https://doi.org/10.1007/s12178-012-9140-0

Koeck, Franz Xaver, Johannes Beckmann, Christian Luring, Bjoern Rath, Joachim Grifka, and Erhan Basad. “Evaluation of Implant Position and Knee Alignment after Patient-Specific Unicompartmental Knee Arthroplasty.” The Knee 18.5 (2011): 294-299. http://dx.doi.org/10.1016/j.knee.2010.06.008

Fitz, Wolfgang. “Unicompartmental Knee Arthroplasty with Use of Novel Patient-Specific Resurfacing Implants and Personalized Jigs.” Journal of Bone and Joint Surgery. American Volume 91.Supplement 1 (2009): 69–76. https://doi.org/10.2106/JBJS.H.01448 http://journals.lww.com/jbjsjournal/Abstract/2009/02001/Unicompartmental_Knee_Arthroplasty_with_Use_of.18.aspx