Objectives: Hip Osteoarthritis (OA) affects a significant component of the adult population, placing itself among the most important causes of disability and need for total hip replacement. Femoroacetabular impingement (FAI) is an anatomic alteration of the proximal femur and/or acetabulum leading to chondro-labral damage and playing a prominent role in OA pathogenesis. Thus, treating FAI is fundamental to relieve hip pain and further joint tissue deterioration. Labral reconstruction is considered the treatment of choice, in particular using tendon allografts or autografts which, however, have some limitations. Here, we investigated the possibility to create a synthetic graft for labral reconstruction to best restore the load bearing and ready to be used in the surgical room.
Methods: The graft was designed analyzing the anatomical structures from intact tissue samples. After a preliminary screening of different polymers, silicone was selected for its flexibility and elasticity to better adhere to the implantation site. We used an FDA-approved biocompatible silicone (VK100), and a mold casting was selected as a fabrication method. Cytocompatibility of VK100 was tested in vitro with an immortalized chondrocytes human cell line (C-28/I2). A cadaver lab was used to test the implantation procedure and to investigate the effects of the device transplantation on hip range of motion, translation, and resultant joint stability. To test the long-term strength of the reconstruction under cyclic loading, synthetic hemipelves were prepared for biomechanical testing and subjected to 10,000 cycles where deflections of up to 5 mm were imposed.
Results: In vitro tests showed that up to 14 days of culture C-28/I2 cells were alive and adherent to VK100 surface with the formation of cell protrusions. As for cell cytotoxicity, a slight increase in LDH levels was observed at 14 days, probably due to the high confluence of adherent cells. We also demonstrated with the ex vivo procedure on cadaver that the device was suitable for arthroscopic implantation without damage or structural compromise during fixation to the acetabular bone. The range of motion and joint stability were preserved after implantation. Furthermore, the graft reconstruction successfully passed strenuous biomechanical cyclic loading. The force peak decreased by less than 10% during the test, indicating no detectable reduction of stiffness nor displacement/failure of the graft. No sign of damage was observed after test completion.
Conclusions: Overall, these results suggest that we have developed a functional synthetic graft that might be quickly transferred to clinical practice.
| [1] |
M. Tannast, D. Goricki, M. Beck, S. B. Murphy, and K. A. Siebenrock, “Hip Damage Occurs at the Zone of Femoroacetabular Impingement,” Clinical Orthopaedics and Related Research 466, no. 2 (2008): 273–280.
|
| [2] |
R. Ganz, M. Leunig, K. Leunig-Ganz, and W. H. Harris, “The Etiology of Osteoarthritis of the Hip: An Integrated Mechanical Concept,” Clinical Orthopaedics and Related Research 466, no. 2 (2008): 264–272.
|
| [3] |
A. Bedi, M. Dolan, M. Leunig, and B. T. Kelly, “Static and Dynamic Mechanical Causes of Hip Pain,” Arthroscopy 27, no. 2 (2011): 235–251.
|
| [4] |
J. B. Mason, “Acetabular Labral Tears in the Athlete,” Clinics in Sports Medicine 20, no. 4 (2001): 779–790.
|
| [5] |
M. R. Safran, G. Giordano, D. P. Lindsey, et al., “Strains Across the Acetabular Labrum During Hip Motion: A Cadaveric Model,” American Journal of Sports Medicine 39, no. Suppl (2011): 92S–102S.
|
| [6] |
M. Beck, M. Kalhor, M. Leunig, and R. Ganz, “Hip Morphology Influences the Pattern of Damage to the Acetabular Cartilage: Femoroacetabular Impingement as a Cause of Early Osteoarthritis of the Hip,” Journal of Bone and Joint Surgery (British Volume) 87, no. 7 (2005): 1012–1018.
|
| [7] |
D. Carreira and C. A. Bush-Joseph, “Hip Arthroscopy,” Orthopedics 29, no. 6 (2006): 517–523.
|
| [8] |
J. R. Ross, C. M. Larson, and A. Bedi, “Indications for Hip Arthroscopy,” Sports Health 9, no. 5 (2017): 402–413.
|
| [9] |
J. C. Clohisy, L. C. St John, and A. L. Schutz, “Surgical Treatment of Femoroacetabular Impingement: A Systematic Review of the Literature,” Clinical Orthopaedics and Related Research 468, no. 2 (2010): 555–564.
|
| [10] |
J. R. Crawford and R. N. Villar, “Current Concepts in the Management of Femoroacetabular Impingement,” Journal of Bone and Joint Surgery (British Volume) 87, no. 11 (2005): 1459–1462.
|
| [11] |
J. McCarthy, P. Noble, F. V. Aluisio, M. Schuck, J. Wright, and J. A. Lee, “Anatomy, Pathologic Features, and Treatment of Acetabular Labral Tears,” Clinical Orthopaedics and Related Research 406 (2003): 38–47.
|
| [12] |
L. Al Mana, R. P. Coughlin, V. Desai, N. Simunovic, A. Duong, and O. R. Ayeni, “The Hip Labrum Reconstruction: Indications and Outcomes-An Updated Systematic Review,” Current Reviews in Musculoskeletal Medicine 12, no. 2 (2019): 156–165.
|
| [13] |
J. W. Byrd and K. S. Jones, “Hip Arthroscopy for Labral Pathology: Prospective Analysis With 10-Year Follow-Up,” Arthroscopy 25, no. 4 (2009): 365–368.
|
| [14] |
A. J. Krych, M. Thompson, Z. Knutson, J. Scoon, and S. H. Coleman, “Arthroscopic Labral Repair Versus Selective Labral Debridement in Female Patients With Femoroacetabular Impingement: A Prospective Randomized Study,” Arthroscopy 29, no. 1 (2013): 46–53.
|
| [15] |
B. Haddad, S. Konan, and F. S. Haddad, “Debridement Versus Re-Attachment of Acetabular Labral Tears: A Review of the Literature and Quantitative Analysis,” Bone & Joint Journal 96-B, no. 1 (2014): 24–30.
|
| [16] |
Z. X. Wu, W. X. Ren, Y. M. Ren, and M. Q. Tian, “Arthroscopic Labral Debridement Versus Labral Repair for Patients With Femoroacetabular Impingement: A Meta-Analysis,” Medicine 99, no. 19 (2020): e20141.
|
| [17] |
B. J. White and M. M. Herzog, “Labral Reconstruction: When to Perform and How,” Frontiers in Surgery 2 (2015): 27.
|
| [18] |
M. J. Philippon, I. K. Bolia, R. Locks, and K. K. Briggs, “Labral Preservation: Outcomes Following Labrum Augmentation Versus Labrum Reconstruction,” Arthroscopy 34, no. 9 (2018): 2604–2611.
|
| [19] |
S. Chandrasekaran, N. Darwish, M. R. Close, P. Lodhia, C. Suarez-Ahedo, and B. G. Domb, “Arthroscopic Reconstruction of Segmental Defects of the Hip Labrum: Results in 22 Patients With Mean 2-Year Follow-Up,” Arthroscopy 33, no. 9 (2017): 1685–1693.
|
| [20] |
B. G. Domb, M. R. Battaglia, I. Perets, et al., “Minimum 5-Year Outcomes of Arthroscopic Hip Labral Reconstruction With Nested Matched-Pair Benchmarking Against a Labral Repair Control Group,” American Journal of Sports Medicine 47, no. 9 (2019): 2045–2055.
|
| [21] |
B. J. White, J. Patterson, and M. M. Herzog, “Revision Arthroscopic Acetabular Labral Treatment: Repair or Reconstruct?,” Arthroscopy 32, no. 12 (2016): 2513–2520.
|
| [22] |
B. J. White, J. Patterson, and M. M. Herzog, “Bilateral Hip Arthroscopy: Direct Comparison of Primary Acetabular Labral Repair and Primary Acetabular Labral Reconstruction,” Arthroscopy 34, no. 2 (2018): 433–440.
|
| [23] |
B. J. White, J. Patterson, A. M. Scoles, A. T. Lilo, and M. M. Herzog, “Hip Arthroscopy in Patients Aged 40 Years and Older: Greater Success With Labral Reconstruction Compared With Labral Repair,” Arthroscopy 36, no. 8 (2020): 2137–2144.
|
| [24] |
P. Lodhia, M. O. McConkey, J. M. Leith, D. R. Maldonado, M. J. Brick, and B. G. Domb, “Graft Options in Hip Labral Reconstruction,” Current Reviews in Musculoskeletal Medicine 14, no. 1 (2021): 16–26.
|
| [25] |
R. Atzmon, J. R. Radparvar, Z. T. Sharfman, A. A. Dallich, E. Amar, and E. Rath, “Graft Choices for Acetabular Labral Reconstruction,” Journal of Hip Preservation Surgery 5, no. 4 (2018): 329–338.
|
| [26] |
R. E. Boykin, D. Patterson, K. K. Briggs, A. Dee, and M. J. Philippon, “Results of Arthroscopic Labral Reconstruction of the Hip in Elite Athletes,” American Journal of Sports Medicine 41, no. 10 (2013): 2296–2301.
|
| [27] |
M. R. Geyer, M. J. Philippon, T. S. Fagrelius, and K. K. Briggs, “Acetabular Labral Reconstruction With an Iliotibial Band Autograft: Outcome and Survivorship Analysis at Minimum 3-Year Follow-Up,” American Journal of Sports Medicine 41, no. 8 (2013): 1750–1756.
|
| [28] |
D. N. Kim, S. Fong, N. Park, et al., “Mid- to Long-Term Outcomes in Patients After Hip Arthroscopy With Labral Reconstruction: A Systematic Review,” Orthopaedic Journal of Sports Medicine 12, no. 6 (2024): 23259671241232306.
|
| [29] |
S. Suppauksorn, K. C. Parvaresh, J. Rasio, E. F. Shewman, and S. J. Nho, “The Effect of Rim Preparation, Labral Augmentation, and Labral Reconstruction on the Suction Seal of the Hip,” Arthroscopy 38, no. 2 (2022): 365–373.
|
| [30] |
M. D. Rahl, C. LaPorte, G. K. Steinl, M. O'Connor, T. S. Lynch, and T. J. Menge, “Outcomes After Arthroscopic Hip Labral Reconstruction: A Systematic Review and Meta-Analysis,” American Journal of Sports Medicine 48, no. 7 (2020): 1748–1755.
|
| [31] |
M. Akhtar, D. Razick, O. Baig, et al., “No Difference in Most Reported Outcome Measures for Allograft Versus Autograft for Hip Labral Reconstruction: A Systematic Review of Comparative Studies,” Arthroscopy 40, no. 11 (2024): 2745–2756.
|
| [32] |
M. Tey-Pons, B. Capurro, R. Torres-Eguia, F. Marques-Lopez, A. Leon-Garcia, and O. Marin-Pena, “Labral Reconstruction With Polyurethane Implant,” Journal of Hip Preservation Surgery 8, no. Suppl 1 (2021): i34–i40.
|
| [33] |
M. Walker, L. Maini, J. Kay, et al., “The Dimensions of the Hip Labrum Can Be Reliably Measured Using Magnetic Resonance and Computed Tomography Which Can Be Used to Develop a Standardized Definition of the Hypoplastic Labrum,” Knee Surgery, Sports Traumatology, Arthroscopy 29, no. 5 (2021): 1432–1452.
|
| [34] |
J. P. Scanaliato, J. Chasteen, M. M. Polmear, C. Salfiti, and A. B. Wolff, “Primary and Revision Circumferential Labral Reconstruction for Femoroacetabular Impingement in Athletes: Return to Sport and Technique,” Arthroscopy 36, no. 10 (2020): 2598–2610.
|
| [35] |
A. O. Inyang, T. Abdalrahman, D. Bezuidenhout, J. Bowen, and C. L. Vaughan, “Suitability of Developed Composite Materials for Meniscal Replacement: Mechanical, Friction and Wear Evaluation,” Journal of the Mechanical Behavior of Biomedical Materials 89 (2019): 217–226.
|
| [36] |
E. Luis, H. M. Pan, S. L. Sing, R. Bajpai, J. H. Song, and W. Y. Yeong, “3D Direct Printing of Silicone Meniscus Implant Using a Novel Heat-Cured Extrusion-Based Printer,” Polymers 12, no. 5 (2020): 1031.
|
| [37] |
A. Gasbarrini, R. Ghermandi, Y. E. Akman, M. Girolami, and S. Boriani, “Elastoplasty as a Promising Novel Technique: Vertebral Augmentation With an Elastic Silicone-Based Polymer,” Acta Orthopaedica et Traumatologica Turcica 51, no. 3 (2017): 209–214.
|
| [38] |
G. Lofrese, F. Cultrera, L. Ricciardi, et al., “Preoperative Elastoplasty of Aggressive Vertebral Hemangiomas in Elderly Patients: A New Strategy for Reducing Intraoperative Bleeding and Complications,” European Spine Journal 33, no. 5 (2024): 1921–1929.
|
| [39] |
W. Song, J. Seta, M. K. Eichler, et al., “Comparison of In Vitro Biocompatibility of Silicone and Polymethyl Methacrylate During the Curing Phase of Polymerization,” Journal of Biomedical Materials Research. Part B, Applied Biomaterials 106, no. 7 (2018): 2693–2699.
|
| [40] |
F. Finger, C. Schorle, A. Zien, P. Gebhard, M. B. Goldring, and T. Aigner, “Molecular Phenotyping of Human Chondrocyte Cell Lines T/C-28a2, T/C-28a4, and C-28/I2,” Arthritis and Rheumatism 48, no. 12 (2003): 3395–3403.
|
| [41] |
M. B. Goldring, J. R. Birkhead, L. F. Suen, et al., “Interleukin-1 Beta-Modulated Gene Expression in Immortalized Human Chondrocytes,” Journal of Clinical Investigation 94, no. 6 (1994): 2307–2316.
|
| [42] |
A. Liguori, E. Petri, C. Gualandi, et al., “Controlled Release of H(2)S From Biomimetic Silk Fibroin-PLGA Multilayer Electrospun Scaffolds,” Biomacromolecules 24, no. 3 (2023): 1366–1376.
|
| [43] |
R. M. Rosenthal, J. Featherall, C. W. Parkes, et al., “Acetabular Labral Reconstruction: Review of Techniques and Outcomes,” Current Reviews in Musculoskeletal Medicine 16, no. 10 (2023): 470–479.
|
| [44] |
J. W. T. Byrd, “Arthroscopic Acetabular Labral Repair Using the Q-FIX Suture Anchor,” Arthroscopy Techniques 8, no. 8 (2019): e801–e805.
|
| [45] |
F. Morosato, F. Traina, and L. Cristofolini, “Effect of Different Motor Tasks on Hip Cup Primary Stability and on the Strains in the Periacetabular Bone: An In Vitro Study,” Clinical Biomechanics 70 (2019): 137–145.
|
| [46] |
F. Morosato, F. Traina, and L. Cristofolini, “Standardization of Hemipelvis Alignment for In Vitro Biomechanical Testing,” Journal of Orthopaedic Research 36, no. 6 (2018): 1645–1652.
|
| [47] |
S. Chegini, M. Beck, and S. J. Ferguson, “The Effects of Impingement and Dysplasia on Stress Distributions in the Hip Joint During Sitting and Walking: A Finite Element Analysis,” Journal of Orthopaedic Research 27, no. 2 (2009): 195–201.
|
| [48] |
L. L. Schuring, J. D. Mozingo, A. L. Lenz, et al., “Acetabular Labrum and Cartilage Contact Mechanics During Pivoting and Walking Tasks in Individuals With Cam Femoroacetabular Impingement Syndrome,” Journal of Biomechanics 146 (2023): 111424.
|
| [49] |
E. Arbabi, S. Chegini, R. Boulic, M. Tannast, S. J. Ferguson, and D. Thalmann, “Penetration Depth Method—Novel Real-Time Strategy for Evaluating Femoroacetabular Impingement,” Journal of Orthopaedic Research 28, no. 7 (2010): 880–886.
|
| [50] |
N. Casartelli, R. Brunner, N. Maffiuletti, et al., “The FADIR Test Accuracy for Screening Cam and Pincer Morphology in Youth Ice Hockey Players,” Swiss Medical Weekly 147 (2017): 53s.
|
| [51] |
C. A. C. Trindade, K. K. Briggs, L. Fagotti, K. Fukui, and M. J. Philippon, “Positive FABER Distance Test Is Associated With Higher Alpha Angle in Symptomatic Patients,” Knee Surgery, Sports Traumatology, Arthroscopy 27, no. 10 (2019): 3158–3161.
|
| [52] |
R. Atzmon, Z. T. Sharfman, B. Haviv, et al., “Does Capsular Closure Influence Patient-Reported Outcomes in Hip Arthroscopy for Femoroacetabular Impingement and Labral Tear?,” Journal of Hip Preservation Surgery 6, no. 3 (2019): 199–206.
|
| [53] |
J. Hernigou, P. Verdonk, Y. Homma, R. Verdonk, S. B. Goodman, and P. Hernigou, “Nonoperative and Operative Bone and Cartilage Regeneration and Orthopaedic Biologics of the Hip: An Orthoregeneration Network (ON) Foundation Hip Review,” Arthroscopy 38, no. 2 (2022): 643–656.
|
| [54] |
A. D. Grant, D. A. Sala, and R. I. Davidovitch, “The Labrum: Structure, Function, and Injury With Femoro-Acetabular Impingement,” Journal of Children's Orthopaedics 6, no. 5 (2012): 357–372.
|
| [55] |
M. E. Domzalski, M. Synder, A. Karauda, and W. Papierz, “Histological Changes of the Acetabular Labrum in Coxarthrosis: Labral Degeneration and Repair,” Hip International 27, no. 1 (2017): 66–73.
|
| [56] |
S. J. Ferguson, J. T. Bryant, R. Ganz, and K. Ito, “The Influence of the Acetabular Labrum on Hip Joint Cartilage Consolidation: A Poroelastic Finite Element Model,” Journal of Biomechanics 33, no. 8 (2000): 953–960.
|
| [57] |
M. N. Nadagouda, M. Ginn, and V. Rastogi, “A Review of 3D Printing Techniques for Environmental Applications,” Current Opinion in Chemical Engineering 28 (2020): 173–178.
|
| [58] |
A. M. E. Arefin, N. R. Khatri, N. Kulkarni, and P. F. Egan, “Polymer 3D Printing Review: Materials, Process, and Design Strategies for Medical Applications,” Polymers 13, no. 9 (2021): 1499.
|
| [59] |
D. Salthouse, K. Novakovic, C. M. U. Hilkens, and A. M. Ferreira, “Interplay Between Biomaterials and the Immune System: Challenges and Opportunities in Regenerative Medicine,” Acta Biomaterialia 155 (2023): 1–18.
|
| [60] |
H. Chen, D. K. Agrawal, and F. G. Thankam, “Biomaterials-Driven Sterile Inflammation,” Tissue Engineering, Part B: Reviews 28, no. 1 (2022): 22–34.
|
RIGHTS & PERMISSIONS
2026 The Author(s). Orthopaedic Surgery published by Tianjin Hospital and John Wiley & Sons Australia, Ltd.
PDF
(755KB)
