Biphasic Cartilage Repair Implant Versus Microfracture in the Treatment of Focal Chondral and Osteochondral Lesions of the Knee: a Prospective, Multi-center, Randomized Clinical Trial

Overview

Journal J Orthop Traumatol

Specialties Emergency Medicine
Orthopedics

Date 2024 Nov 30

PMID 39614986

Authors

Tzu-Hao Tseng

Chao-Ping Chen

Ching-Chuan Jiang

Pei-Wei Weng

Yi-Sheng Chan

Horng-Chaung Hsu

Hongsen Chiang

Affiliations

Soon will be listed here.

Abstract

Background: Autologous minced cartilage is a method for cartilage defect repair, and our study focuses on a newly developed biphasic cylindrical osteochondral construct designed for use in human knees. We aimed to compare its clinical effectiveness and safety with microfracture, the commonly utilized reparative treatment for knee chondral or osteochondral defects.

Materials And Methods: Conducted as a prospective multicenter, randomized controlled, non-inferiority trial across nine hospitals, the study involved 92 patients with International Cartilage Repair Society (ICRS) grade 3 to 4 chondral or osteochondral lesions on femoral condyles. Patients were evenly randomized to receive either the biphasic cartilage-repair implant (BiCRI) or microfracture. Functional outcomes and safety assessments were conducted at postoperative intervals of 6 weeks and 3, 6, and 12 months. Primary and secondary endpoints included International Knee Documentation Committee (IKDC) 2000 Subjective Knee Evaluation Form score improvement, the grade distribution in the IKDC 2000 Knee Examination Form, and various assessments, such as the Knee Injury and Osteoarthritis Outcome Score (KOOS), visual analog scales (VASs) for pain, MRI findings, and arthroscopic findings at 12 months.

Results: Out of the initial participants, 47 in the BiCRI group and 45 in the microfracture group completed the follow-up. At 12 months, the mean change in IKDC total score was 25.56 ± 18.48 for BiCRI and 27.51 ± 23.65 for microfracture. The 95% confidence interval (CI) for the score difference (BiCRI minus microfracture) was - 6.95, exceeding the non-inferiority margin of - 12. Secondary endpoints indicated comparable functional outcomes, and arthroscopic findings demonstrated more fully regenerated cartilage in the BiCRI group.

Conclusion: Based on the IKDC 2000 Subjective Knee Evaluation Form score, BiCRI proved non-inferior to microfracture at 12 months. Short-term functional outcomes were comparable to those with microfracture, while arthroscopic findings showed more complete cartilage regeneration in the BiCRI group. Consequently, BiCRI emerges as a viable alternative for treating chondral or osteochondral defects.

Level Of Evidence: Level 2, multi-center, randomized clinical trial.

Trial Registration: Name of the registry: ClinicalTrials.gov.

Trial Registration Number: NCT01477008. Date of registration: 11/14/2011. URL of trial registry record: clinicaltrials.gov/study/NCT01477008.

References

Greco N, Anderson A, Mann B, Cole B, Farr J, Nissen C . Responsiveness of the International Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with.... Am J Sports Med. 2010; 38(5):891-902. DOI: 10.1177/0363546509354163. View

Song S, Park C . Microfracture for cartilage repair in the knee: current concepts and limitations of systematic reviews. Ann Transl Med. 2019; 7(Suppl 3):S108. PMC: 6685863. DOI: 10.21037/atm.2019.05.11. View

Mithoefer K, McAdams T, Williams R, Kreuz P, Mandelbaum B . Clinical efficacy of the microfracture technique for articular cartilage repair in the knee: an evidence-based systematic analysis. Am J Sports Med. 2009; 37(10):2053-63. DOI: 10.1177/0363546508328414. View

Kon E, Gobbi A, Filardo G, Delcogliano M, Zaffagnini S, Marcacci M . Arthroscopic second-generation autologous chondrocyte implantation compared with microfracture for chondral lesions of the knee: prospective nonrandomized study at 5 years. Am J Sports Med. 2008; 37(1):33-41. DOI: 10.1177/0363546508323256. View

Liao C, Chen C, Chen J, Lin Y, Chang K . Fabrication of porous biodegradable polymer scaffolds using a solvent merging/particulate leaching method. J Biomed Mater Res. 2002; 59(4):676-81. DOI: 10.1002/jbm.10030. View

Kreuz P, Steinwachs M, Erggelet C, Krause S, Konrad G, Uhl M . Results after microfracture of full-thickness chondral defects in different compartments in the knee. Osteoarthritis Cartilage. 2006; 14(11):1119-25. DOI: 10.1016/j.joca.2006.05.003. View

Tuan R, Chen A, Klatt B . Cartilage regeneration. J Am Acad Orthop Surg. 2013; 21(5):303-11. PMC: 4886741. DOI: 10.5435/JAAOS-21-05-303. View

Chiang H, Liao C, Hsieh C, Shen C, Huang Y, Jiang C . Clinical feasibility of a novel biphasic osteochondral composite for matrix-associated autologous chondrocyte implantation. Osteoarthritis Cartilage. 2013; 21(4):589-98. DOI: 10.1016/j.joca.2013.01.004. View

Lu Y, Dhanaraj S, Wang Z, Bradley D, Bowman S, Cole B . Minced cartilage without cell culture serves as an effective intraoperative cell source for cartilage repair. J Orthop Res. 2006; 24(6):1261-70. DOI: 10.1002/jor.20135. View

10.

Brittberg M, Lindahl A, Nilsson A, Ohlsson C, Isaksson O, Peterson L . Treatment of deep cartilage defects in the knee with autologous chondrocyte transplantation. N Engl J Med. 1994; 331(14):889-95. DOI: 10.1056/NEJM199410063311401. View

11.

Uchio Y, Kuroda R, Niki Y, Sugawara K, Ishibashi Y . Effectiveness and Safety of Matrix-Associated Autologous Chondrocyte Implantation for the Treatment of Articular Cartilage Defects: A Real-World Data Analysis in Japan. Am J Sports Med. 2024; 52(13):3232-3243. DOI: 10.1177/03635465241282671. View

12.

Heir S, Nerhus T, Rotterud J, Loken S, Ekeland A, Engebretsen L . Focal cartilage defects in the knee impair quality of life as much as severe osteoarthritis: a comparison of knee injury and osteoarthritis outcome score in 4 patient categories scheduled for knee surgery. Am J Sports Med. 2010; 38(2):231-7. DOI: 10.1177/0363546509352157. View

13.

Knutsen G, Drogset J, Engebretsen L, Grontvedt T, Ludvigsen T, Loken S . A Randomized Multicenter Trial Comparing Autologous Chondrocyte Implantation with Microfracture: Long-Term Follow-up at 14 to 15 Years. J Bone Joint Surg Am. 2016; 98(16):1332-9. DOI: 10.2106/JBJS.15.01208. View

14.

Yoon K, Yoo J, Choi C, Lee J, Lee J, Kim S . Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation versus Microfracture for Repair of Articular Cartilage Defects: A Prospective Randomized Trial. Cartilage. 2020; 13(1_suppl):1092S-1104S. PMC: 8808917. DOI: 10.1177/1947603520921448. View

15.

Hoburg A, Niemeyer P, Laute V, Zinser W, Becher C, Kolombe T . Sustained superiority in KOOS subscores after matrix-associated chondrocyte implantation using spheroids compared to microfracture. Knee Surg Sports Traumatol Arthrosc. 2022; 31(6):2482-2493. DOI: 10.1007/s00167-022-07194-x. View

16.

Chiang H, Kuo T, Tsai C, Lin M, She B, Huang Y . Repair of porcine articular cartilage defect with autologous chondrocyte transplantation. J Orthop Res. 2005; 23(3):584-93. DOI: 10.1016/j.orthres.2004.11.003. View

17.

Mundi R, Bedi A, Chow L, Crouch S, Simunovic N, Sibilsky Enselman E . Cartilage Restoration of the Knee: A Systematic Review and Meta-analysis of Level 1 Studies. Am J Sports Med. 2015; 44(7):1888-95. DOI: 10.1177/0363546515589167. View

18.

Liao C, Lin Y, Chiang H, Chiang S, Wang Y, Jiang C . Injecting partially digested cartilage fragments into a biphasic scaffold to generate osteochondral composites in a nude mice model. J Biomed Mater Res A. 2006; 81(3):567-77. DOI: 10.1002/jbm.a.31035. View

19.

Aroen A, Loken S, Heir S, Alvik E, Ekeland A, Granlund O . Articular cartilage lesions in 993 consecutive knee arthroscopies. Am J Sports Med. 2004; 32(1):211-5. DOI: 10.1177/0363546503259345. View

20.

Mistry H, Connock M, Pink J, Shyangdan D, Clar C, Royle P . Autologous chondrocyte implantation in the knee: systematic review and economic evaluation. Health Technol Assess. 2017; 21(6):1-294. PMC: 5346885. DOI: 10.3310/hta21060. View