Comparison of autologous osteoperiosteal cylinder and osteochondral graft transplantation in the treatment of large cystic osteochondral lesions of the talus (OLTs): a protocol for a non-inferiority randomised controlled trial

En Deng, Weili Shi, Yanfang Jiang, Qinwei Guo, En Deng, Weili Shi, Yanfang Jiang, Qinwei Guo

Abstract

Introduction: Large cystic osteochondral lesions of the talus (OLTs) have been shown to have inferior clinical outcomes after reparative techniques such as bone marrow stimulation. Autologous osteochondral transplantation has been viewed as an alternative choice for treating these lesions, but donor-site morbidity has limited its application. Excellent clinical outcomes have been shown in repairing these types of lesions with autologous osteoperiosteal grafts, and these outcomes are achieved at a low cost and without donor-site morbidity in the normal knee joint. This will be the first randomised controlled trial to compare the two surgical techniques, and recommendations for the treatment of patients with large cystic OLTs will be provided.

Methods and analysis: A non-inferiority randomised controlled trial will be conducted. A total of 70 participants with clinically diagnosed large cystic OLTs will be randomly allocated to either the experimental group or the control group at a ratio of 1:1. The experimental group will be treated with autologous osteoperiosteal cylinder graft transplantation, while the control group will be treated with autologous osteochondral transplantation. The primary outcome measure will be the American Orthopaedic Foot & Ankle Society Ankle-Hindfoot Score and the Short Form 12 (SF-12) questionnaire. Secondary outcome measures will include the secondary arthroscopy International Cartilage Repair Society score, the Magnetic Resonance Observation of Cartilage Repair Tissue score, the Tegner activity level score, the visual analogue scale, routine X-rays, CT and complications. These parameters will be evaluated preoperatively, as well as at 3, 6, 12, 24, 36 and 60 months postoperatively. In this trial, we hypothesised that both procedures offer good results for the treatment of patients with large cystic OLTs, and occurrence of donor-site morbidity in autologous osteoperiosteal cylinder graft transplantation group is less than that in autologous osteochondral transplantation group.

Ethics and dissemination: The current study was approved by the board of research ethics of Peking University Third Hospital Medical Science Research Ethics Committee. The results of this study will be presented at national and international conferences and published in peer-reviewed journals.

Trial registration number: NCT03347877.

Keywords: Foot & ankle; osteochondral lesion; sports medicine; surgery; talus.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Trial workflow. AOFAS, American Orthopaedic Foot & Ankle Society; ICRS, International Cartilage Repair Society; MOCART, Magnetic Resonance Observation of Cartilage Repair Tissue; OLTs, osteochondral lesions of the talus; ROM, range of motion; SF-12, Short Form 12 questionnaire; Tegner, Tegner activity level; VAS, visual analogue scale.
Figure 2
Figure 2
(A) Small pieces of cancellous bone harvested from the iliac crest will be used to fill the peripheral area of the cyst, and the osteoperiosteal graft will be implanted into the bone socket in the talus; (B) small pieces of cancellous bone harvested from the non-weight-bearing portion of the ipsilateral medial femoral trochlea in the ipsilateral knee will be used to fill the peripheral area of the cyst, and the osteochondral graft will be implanted into the bone socket in the talus.

References

    1. O'Loughlin PF, Heyworth BE, Kennedy JG. Current concepts in the diagnosis and treatment of osteochondral lesions of the ankle. Am J Sports Med 2010;38:392–404. 10.1177/0363546509336336
    1. Leumann A, Valderrabano V, Plaass C, et al. . A novel imaging method for osteochondral lesions of the talus--comparison of SPECT-CT with MRI. Am J Sports Med 2011;39:1095–101. 10.1177/0363546510392709
    1. Waterman BR, Belmont PJ, Cameron KL, et al. . Epidemiology of ankle sprain at the United States military Academy. Am J Sports Med 2010;38:797–803. 10.1177/0363546509350757
    1. Lee K-B, Bai L-B, Chung J-Y, et al. . Arthroscopic microfracture for osteochondral lesions of the talus. Knee Surg Sports Traumatol Arthrosc 2010;18:247–53. 10.1007/s00167-009-0914-x
    1. Shimozono Y, Coale M, Yasui Y, et al. . Subchondral bone degradation after Microfracture for osteochondral lesions of the talus: an MRI analysis. Am J Sports Med 2018;46:642–8. 10.1177/0363546517739606
    1. Hannon CP, Bayer S, Murawski CD, et al. . Debridement, curettage, and bone marrow stimulation: proceedings of the International consensus meeting on cartilage repair of the ankle. Foot Ankle Int 2018;39:16S–22. 10.1177/1071100718779392
    1. Lee K-bae, Park H-won, Cho H-jong, et al. . Comparison of arthroscopic Microfracture for osteochondral lesions of the talus with and without Subchondral cyst. Am J Sports Med 2015;43:1951–6. 10.1177/0363546515584755
    1. Walley KC, Gonzalez TA, Callahan R, et al. . The role of 3D reconstruction True-Volume analysis in osteochondral lesions of the talus: a case series. Foot Ankle Int 2018;39:1113–9. 10.1177/1071100718771834
    1. Zengerink M, Struijs PAA, Tol JL, et al. . Treatment of osteochondral lesions of the talus: a systematic review. Knee Surg Sports Traumatol Arthrosc 2010;18:238–46. 10.1007/s00167-009-0942-6
    1. Erggelet C, Endres M, Neumann K, et al. . Formation of cartilage repair tissue in articular cartilage defects pretreated with microfracture and covered with cell-free polymer-based implants. J Orthop Res 2009;27:1353–60. 10.1002/jor.20879
    1. Kanatlı U, Eren A, Eren TK, et al. . Single-Step arthroscopic repair with cell-free polymer-based scaffold in osteochondral lesions of the talus: clinical and radiological results. Arthroscopy 2017;33:1718–26. 10.1016/j.arthro.2017.06.011
    1. Dekker TJ, Steele JR, Federer AE, et al. . Efficacy of Particulated juvenile cartilage allograft transplantation for osteochondral lesions of the talus. Foot Ankle Int 2018;39:278–83. 10.1177/1071100717745502
    1. VanTienderen RJ, Dunn JC, Kusnezov N, et al. . Osteochondral allograft transfer for treatment of osteochondral lesions of the talus: a systematic review. Arthroscopy 2017;33:217–22. 10.1016/j.arthro.2016.06.011
    1. Shimozono Y, Seow D, Yasui Y, et al. . Knee-to-Talus donor-site morbidity following autologous osteochondral transplantation: a meta-analysis with Best-case and worst-case analysis. Clin Orthop Relat Res 2019;477:1915–31. 10.1097/CORR.0000000000000719
    1. Hu Y, Guo Q, Jiao C, et al. . Treatment of large cystic medial osteochondral lesions of the talus with autologous osteoperiosteal cylinder grafts. Arthroscopy 2013;29:1372–9. 10.1016/j.arthro.2013.05.014
    1. Malliaropoulos N, Papacostas E, Papalada A, et al. . Acute lateral ankle sprains in track and field athletes: an expanded classification. Foot Ankle Clin 2006;11:497–507. 10.1016/j.fcl.2006.05.004
    1. Kohn MD, Sassoon AA, Fernando ND. Classifications in brief: Kellgren-Lawrence classification of osteoarthritis. Clin Orthop Relat Res 2016;474:1886–93. 10.1007/s11999-016-4732-4
    1. Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis 1957;16:494–502. 10.1136/ard.16.4.494
    1. Flynn S, Ross KA, Hannon CP, et al. . Autologous osteochondral transplantation for osteochondral lesions of the talus. Foot Ankle Int 2016;37:363–72. 10.1177/1071100715620423
    1. Haleem AM, Ross KA, Smyth NA, et al. . Double-Plug autologous osteochondral transplantation shows equal functional outcomes compared with Single-Plug procedures in lesions of the Talar dome: a minimum 5-year clinical follow-up. Am J Sports Med 2014;42:1888–95. 10.1177/0363546514535068
    1. Baltzer AWA, Ostapczuk MS, Terheiden HP, et al. . Good short- to medium-term results after osteochondral autograft transplantation (OAT) in middle-aged patients with focal, non-traumatic osteochondral lesions of the knee. Orthop Traumatol Surg Res 2016;102:879–84. 10.1016/j.otsr.2016.06.004
    1. Nakasa T, Adachi N, Kato T, et al. . Appearance of Subchondral bone in computed tomography is related to cartilage damage in osteochondral lesions of the Talar dome. Foot Ankle Int 2014;35:600–6. 10.1177/1071100714528493
    1. Madry H, van Dijk CN, Mueller-Gerbl M. The basic science of the subchondral bone. Knee Surg Sports Traumatol Arthrosc 2010;18:419–33. 10.1007/s00167-010-1054-z
    1. Nakasa T, Ikuta Y, Yoshikawa M, et al. . Added value of preoperative computed tomography for determining cartilage degeneration in patients with osteochondral lesions of the Talar dome. Am J Sports Med 2018;46:208–16. 10.1177/0363546517732035
    1. Takao M, Innami K, Komatsu F, et al. . Retrograde cancellous bone plug transplantation for the treatment of advanced osteochondral lesions with large subchondral lesions of the ankle. Am J Sports Med 2010;38:1653–60. 10.1177/0363546510364839

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