Are the Biological and Biomechanical Properties of Meniscal Scaffolds Reflected in Clinical Practice? A Systematic Review of the Literature
Abstract
:1. Introduction
2. Results
2.1. Coleman Methodology Score
2.2. Demographic Features of the Patients and Lesions Treated
2.3. Clinical Outcome Measures and MRI Outcome Measures
2.4. Second-Look Arthroscopy and Histological Evaluation of Biopsies
2.5. Complications and Treatment Failures
2.6. Do the Scaffolds Improve Clinical Outcomes?
2.7. Do the Scaffolds Have a Chondroprotective Effect?
2.8. How Are the Properties of the Scaffold Reflected in the Genovese Signal Intensity and Morphology Scores?
3. Discussion
3.1. Quality of Included Studies
3.2. How do the Scaffolds Perform in Relation to Clinical Outcomes?
3.3. Is Initial Porosity and Maturation of the Scaffolds Evident after Implantation?
3.4. Do Scaffolds Resorb Well, as Assessed by MRI?
3.5. Do the Scaffolds Have Chondroprotective Properties?
3.6. Are the Regenerative Properties of the Scaffolds Evident?
3.7. Are the Integrative Properties of the Scaffolds Evident?
3.8. Limitations
3.9. The Future of Meniscal Scaffolds
4. Methods
5. Conclusions
Supplementary Materials
Author Contributions
Conflicts of Interest
Abbreviations
ACL | Anterior Cruciate Ligament |
CMI | Collagen Meniscus Implant |
CMS | Coleman Methodology Score |
ECM | Extracellular Matrix |
EQ-5D | EuroQol 5 dimensions |
GelMA | Gelatin methacrylamide |
GAG | Glycosaminoglycan |
MeHA | Methacrylated hyaluronic acid |
HA | Hyaluronic Acid |
ICRS | International Cartilage Repair Society |
IKDC | International Knee Documentation Committee Score |
KOOS ADL | Knee injury and Osteoarthritis Outcome Function in daily life score, |
KOOS QOL | Knee injury and Osteoarthritis Outcome Quality of Life score |
KOOS Sport/rec | Knee injury and Osteoarthritis Outcome Function in Sport and Recreation score |
KOOS Symp/stiffness | Knee injury and Osteoarthritis Outcome Symptom score, KSS Knee Society Score, |
KSS | Knee Society Score |
M | Months |
MAT | Meniscal Allograft Transplantation |
MRI | Magnetic resonance imaging |
N/A | Not Applicable |
NO | Nitric Acid |
NR | Not Reported |
PRISMA | Preferred Reporting Items for Systematic Reviews and Meta-Analyses |
UCLA | University of California, Los Angeles activity scale, |
VAS | Visual Analog Scale |
Y | Years |
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Author | Year | Type of Meniscal Implant or Scaffold | Number of Patients | Mean Patient Age (Y) | Male:Female | Type of Lesion: Medial or Lateral | Mean Follow-up (Range) (M) | Details of Concomitant Procedure |
---|---|---|---|---|---|---|---|---|
Bulgheroni [25] | 2013 | Actifit | 19 | 32.8 | 17:2 | 16 medial, 2 lateral, 1 bilateral | 24 (24–46) | 17 patients: 8 ACL reconstructions, 1 ACL repair, 7 high tibial osteotomies and 1 femoral osteotomy |
Dhollander [26] | 2016 | Actifit | 44 | 32.1 | 24:20 | 29 medial and 15 lateral | 60 (24–60) | 8 patients: 4 ACL reconstructions and 4 high tibial osteotomies |
Leroy [27] | 2017 | Actifit | 15 | 30.0 | 8:7 | 6 medial 9 lateral | 72 (60–97.2) | 6 patients: 5 ACL reconstructions, 1 mosaicplasty |
Schuttler [28] | 2015 | Actifit | 18 | 32.5 | NR | 18 medial | NR - minimum 24 | No patients |
Bulgheroni [22] | 2010 | CMI | 34 | 39.0 | 25:9 | 34 medial | NR (60–76) | 14 patients: 11 ACL reconstructions, 2 high tibial osteotomies and 1 microfracture |
Zaffagnini [23] | 2011 | CMI | 17 | 38.0 | 17:0 | 17 medial | 135 (120–152) | 2 patients: 2 ACL reconstructions |
Zaffagnini [24] | 2012 | CMI | 24 | 36.3 | 20:4 | 24 lateral | 26 (24–31) | 11 patients: 4 ACL reconstructions, 6 lateral tibial plateau microfractures, 1 ACL cyst removal |
Bulgheroni [29] | 2016 | CMI and Actifit | 28 CMI; 25 Actifit | 38.7 CMI; 34.4 Actifit | 19:9 CMI; 20:5 Actifit | 53 medial | NR—minimum 24 | Actifit—25 patients: 11 tibial osteotomies, 9 ACL reconstructions, 3 microfractures, 1 healing response, 1 suture CMI—15 patients: 3 tibial osteotomies, 11 ACL reconstructions and 1 microfracture |
Author | Year | Clinical Scores (Mean ± Standard Deviation) | OR Description of Main Clinical Results | ||||
---|---|---|---|---|---|---|---|
0M | 6M | 12M | 24M | 60M | |||
ACTIFIT | |||||||
Bulgheroni [25] | 2013 | Lysholm: 66.2 | 86.8* | 90.7 | 90.5 | - | Clinical outcome scores were significantly improved after 6M compared to baseline. |
Tegner: 3.8 | 4.1* | 4.9 | 6 | - | |||
VAS: 6.23 | 3.07* | 2.1 | 1.94 | - | |||
Dhollander [26] | 2016 | KOOS Total: 206.5 ± 79.7 | - | - | 329.8 ± 108.9* | 333.6 ± 112.2* | All post-operative clinical outcome scores showed statistically significant improvement when compared to baseline. |
KOOS Pain: 48.3 ± 20.3 | - | - | 72.9 ± 23.6* | 77.2 ± 24.5* | |||
KOOS Symp/stiffness: 52.4 ± 19.7 | - | - | 73.2 ± 18.4* | 69.4 ± 20.9* | |||
KOOS ADL: 54.4 ± 21.5 | - | - | 77.1 ± 23.9* | 80.2 ± 26.1* | |||
KOOS sport/rec: 19.1 ± 20.0 | - | - | 57.0 ± 35.6* | 49.7 ± 34.8* | |||
KOOS QOL: 32.2 ± 14.2 | - | - | 49.6 ± 21.6* | 56.9 ± 24.0* | |||
VAS for pain: 56.2 ± 21.6 | - | - | 24.6 ± 22.7* | 19.3 ± 26.9* | |||
IKDC subjective form: 38.7 ± 14.8 | - | - | 63.4 ± 24.3* | 66.9 ± 23.1* | |||
Leroy [27] | 2017 | Intention to treat group | |||||
VAS: 5.5 ± 2.0 | - | 3.7 ± 2 | 2.9 ± 2.1 | 2.9 ± 2.6* | Intention to treat group: VAS and IKDC subjective score statistically improved from baseline to final post-operative timepoint, with no other measures showing statistical improvement. | ||
IKDC subjective: 51.2 ± 20 | - | 62.1 ± 19 | 65.1 ± 22 | 66.1 ± 23 | |||
IKDC objective: 2A/6B/3C/2D | - | 4A/5B/3C/1D | 3A/2B/7C/1D | 2A/7B/3C/1D | |||
KOOS Symp/stiffness: 69.4 ± 13 | - | 75 ± 14 | 76.5 ± 15 | 68.3 ± 23 | |||
KOOS pain: 62.9 ± 15 | - | 75 ± 16 | 77.8 ± 18 | 76.1 ± 25 | |||
KOOS ADL: 72 ± 20 | - | 79.7 ± 14 | 83.5 ± 17 | 81.7 ± 23 | |||
KOOS Sport/rec: 51.2 ± 14 | - | 55.8 ± 21 | 61.2 ± 17 | 53.5 ± 33 | |||
KOOS QOL: 40.9 ± 18 | - | 57.7 ± 27 | 64.3 ± 25 | 59.9 ± 31 | |||
Per protocol group | |||||||
VAS: 5.3 ± 2.2 | - | - | - | 1.9 ± 1.7* | Per protocol group: VAS, IKDC subjective, KOOS pain, KOOS daily activities and KOOS QOL were statistically improved from baseline to final post-operative time point with no other measures showing statistical improvement | ||
IKDC subjective: 49.6 ± 19 | - | - | - | 75.4 ± 15* | |||
IKDC objective: 1A/5B/2C/2D | - | - | - | 2A/6B/2C/0D | |||
KOOS symp/stiffness: 67.1 ± 14 | - | - | - | 76.3 ± 16 | |||
KOOS pain: 60.6 ± 16 | - | - | - | 86 ± 13* | |||
KOOS ADL: 70.3 ± 21 | - | - | - | 90.2 ± 11* | |||
KOOS sport/rec: 50.5 ± 14 | - | - | - | 65.5 ± 25 | |||
KOOS QOL: 42.7 ± 17 | - | - | - | 71.1 ± 25* | |||
Schuttler [28] | 2015 | KOOS pain: 47 ± 14.5 | KOOS pain: 75 ± 17.7* | KOOS pain: 82 ± 17.4* | KOOS pain: 83 ± 18.6* | - | All KOOS subdomains showed statistically significant improvements comparing preoperative and 24M scores. KSS function and knee both showed statistically significant improvement over whole time period. VAS: Statistically significant reduction compared to baseline at every time point. UCLA: Statistically significant increase compared to baseline was only seen at 2 years. |
KOOS symp/stiffness: 60 ± 16.2 | KOOS symp/stiffness: 67 ± 18.5* | KOOS symp/stiffness: 85 ± 9.7* | KOOS symp/stiffness: 81 ± 13.4* | ||||
KOOS ADL: 53.1 ± 16.0 | KOOS ADL: 85 ± 14.5* | KOOS ADL: 88 ± 13.0* | KOOS ADL: 91 ± 14.7* | ||||
KOOS Sport/rec:26 ± 20.5 | KOOS Sport/Rec: 60 ± 25.3* | KOOS Sport/Rec: 68 ± 24.5* | KOOS Sport/Rec: 66 ± 28.5* | ||||
KOOS QOL: 28 ± 16.6 | KOOS QOL: 55 ± 26.9* | KOOS QOL: 67 ± 20.4* | KOOS QOL: 63 ± 18.9* | ||||
KSS function score: 61 ± 22.2 | KSS function score: 87 ± 10.2* | KSS function score: 89 ± 15.7* | KSS function score: 96 ± 7.9* | ||||
KSS knee score: 65 ± 9.4 | KSS knee score: 89 ± 13.1* | KSS knee score: 87 ± 14.1* | KSS knee score: 88 ± 12.4* | ||||
UCLA: 5.4 ± 1.8 | UCLA: 6.1 ± 1.8 | UCLA: 6.5 ± 2.1 | UCLA: 7.3 ± 1.8* | ||||
VAS: 5.1 ± 2.0 | VAS: 2.1 ± 2.4* | VAS: 1.8 ± 2.3* | VAS: 1.5 ± 2.1* | ||||
CMI | |||||||
Bulgheroni [22] | 2010 | Lysholm: 58 | - | - | 94* | - | Both clinical outcome scores showed statistically significant improvements comparing 24M to baseline. |
Tegner: 2 | - | - | 5* | - | |||
Zaffagnini [23] | 2011 | - | - | - | - | - | Comparing 10-year follow-up to baseline, statistically significant improvements seen in all clinical outcome measures: VAS, Lysholm, SF-36 PHI, SF-36 MI, IKDC and Tegner scales. |
Zaffagnini [24] | 2012 | Lysholm: 64 ± 16.2 | 89.9 ± 11.4* | - | 92.7 ± 13.8* | - | All clinical outcome scores showed statistically significant improvements from baseline to last post-operative follow up. |
VAS: 55.2 ± 29.4 | 18.3 ± 18.1* | - | 19.5 ± 25.6* | - | |||
Tegner: 3 (median) | 4 (median) | - | 5 (median)* | - | |||
Objective IKDC: 6A, 14B, 4C, 0D | 20A, 3B, 0C, 1D* | - | 20A, 3B, 0C, 1D* | - | |||
EQ-5D: 0.579 ± 0.28 | - | - | 0.892 ± 0.14* | - | |||
ACTIFIT VS CMI | |||||||
Bulgheroni [29] | 2016 | CMI Group | |||||
Lysholm: 58.4 ± 17.3 | - | 92.5 ± 8.5* | 94.5 ± 6.0* (at minimum 24M follow-up) | - | In both CMI and Actifit groups, all clinical outcome scores showed a statistically significant improvement across the follow-up period when compared to baseline. However, none of the differences between values at 12M and final-follow up reached statistical significance. | ||
Tegner:2 | - | 5* | 5* (at minimum 24M follow-up) | - | |||
Actifit Group | |||||||
Lysholm: 67.0 ± 15.7 | - | 87.4 ± 13.0* | 90.3 ± 13.1* (at minimum 24M follow-up) | - | As above | ||
Tegner:4 | - | 4* | 5* (at minimum 24M follow-up) | - |
Author | Year | MRI Findings | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Yulish Score at Follow-up (M) | ICRS Grade at Follow-up (M) | Genoverse Grading | |||||||||
0 | 24-120M | Final Follow-up | Or Description of Yulish Results | 0 | 24 | 60 | Or Description of ICRS Grade Finding | Genovese Morphology at Follow-up | Genovese Signal Intensity at Follow-up | ||
ACTIFIT | |||||||||||
Bulgheroni [22] | 2013 | 1 | At 24M: 1.1 | Articular cartilage was not degenerated | 12 M: 1.3 24 M: 1.4 Scaffolds did not change in morphology. | 12M: Grade 2 24 M: Grade 2 | |||||
Dhollander [26] | 2016 | Patient 1: 2 | Patient 1: 2 | Patient 1: 3a | Cartilage of the index compartment remained stable in 46.7% of patients after 5 years. 1 patient showed a temporary improvement in cartilage after 2 years which then deteriorated at 5-year follow-up. The remaining 46.7% patients showed a deterioration in cartilage. A chondroprotective effect was therefore not seen. | 24M and 60M: Grade type 2b in all patients | 24M and 60M: Grade 1 in 60% of patients, grade 2 in 40% of patients | ||||
Patient 2: 2 | Patient 2: 1 | Patient 2: 3a | |||||||||
Patient 3: 0 | Patient 3: 1 | Patient 3: 2 | |||||||||
Patient 4: 1 | Patient 4: 1 | Patient 4: 2 | |||||||||
Patient 5: 1 | Patient 5: 1 | Patient 5: 3a | |||||||||
Patient 6: 1 | Patient 6: 1 | Patient 6: 1 | |||||||||
Patient 7: 0 | Patient 7: 0 | Patient 7: 1 | |||||||||
Patient 8: 0 | Patient 8: 0 | Patient 8: 0 | |||||||||
Patient 9: 0 | Patient 9: 0 | Patient 9: 0 | |||||||||
Patient 10: 1 | Patient 10: 2 | Patient 10: 2 | |||||||||
Patient 11: 0 | Patient 11: 0 | Patient 11: 3b | |||||||||
Patient 12: 0 | Patient 12: 0 | Patient 12: 0 | |||||||||
Patient 13: 0 | Patient 13: 0 | Patient 13: 0 | |||||||||
Patient 14: 0 | Patient 14: 0 | Patient 14: 0 | |||||||||
Patient 15: 0 | Patient 15: 0 | Patient 15: 0 | |||||||||
Leroy [27] | 2017 | 6 patients with Grade 0. | Mean ICRS grade was stable pre-operatively to 60M follow-up. | 14.4M and 60M: Average Grade 2 | 14.4M and 60M: Average Grade 2 | ||||||
1 patient with Grade 1. | |||||||||||
3 patients with Grade 2. | |||||||||||
3 patients with Grade 3. | |||||||||||
2 patients with Grade 4. | |||||||||||
Schuttler [28] | 2015 | 89% of patients showed stable articular cartilage from 6 months to 24 months follow-up. 11% of patients showed interval progression of 1 or more ICRS grades from 6 months to 24 months follow-up. 27.8% of patients showed improvements in chondral wear after 24 months. Overall, there was no significant difference in cartilage damage comparing consecutive MRIs. | 1 patient showed Grade 1 after 24M. All other results not specified. | 24M: All patients showed Grade 1 or Grade 2 signal intensity. (numbers not specified) | |||||||
CMI | |||||||||||
Bulgheroni [22] | 2010 | At 24M: Grade 0 in 67% of patients, Grade 1 in 14% of patients, Grade 2 in 4% of patients, Grade 3 in 4% of patients, Grade 4 in 11% of patients. | At 60M, Grade 0 in 60% of patients, Grade 1 in 14% of patients, Grade 2 in 11% of patients, Grade 3 in 4% of patients, Grade 4 in 11% of patients. | No signs of degeneration of the articular cartilage of medial compartment. | 2Y: Grade 2 in 60.7% of patients 5Y: Grade 2 in 71.4% of patients. The remaining patients had Grade 3 morphology. | 2Y: Majority of patients showed Grade 1 intensity 5Y: Majority of patients showed Grade 2 intensity (percentages not specified) | |||||
Zaffagnini [23] | 2011 | 2 ± 1.5 (median) | At 120M: 2 (median) | Articular cartilage seemed to be preserved across the follow-up period, however this did not reach statistical significance | At 60M and 120M: 2 (median) | At 60M and 120M: 2 (median). | |||||
Zaffagnini [24] | 2012 | Lateral Tibial Plateau: Modified score: 1.5 (1.0-2.0) (median, IQR) Lateral Femoral Condyle: Modified score: 2.0 (1.0-2.0) (median, IQR) | Lateral Tibial Plateau: Modified score: 1.0 (1.0-0.5) (median, IQR). Lateral Femoral Condyle: Modified score: 1.5 (1.0-2.0) (median, IQR) | Mean modified Yulish scores showed an improvement comparing baseline to final post-operative scores for both lateral femoral condyle and lateral tibial plateau, however this did not reach statistical significance | 24M: 75% had Grade 2, 12.5% had Grade 1, 12.5% had Grade 3 | 24M: 50% of patients had Grade 2, 37.5% had Grade 3 (remaining not specified) | |||||
ACTIFIT VS CMI | |||||||||||
Bulgheroni [29] | 2016 | CMI patients: Preoperatively: 67.9% of patients showed Grade 0, 14.3% showed Grade 1, 3.6% showed Grade 2, 3.6% showed Grade 3, 10.7% showed Grade 4. Actifit patients: Preoperatively: 16% of patients showed Grade 0, 36% showed Grade 1, 32% showed Grade 2, 12% showed Grade 3, 4% showed Grade 4. | CMI patients: 2 years: 60.7% of patients showed Grade 0, 14.3% showed Grade 1, 10.7% showed Grade 2, 3.6% showed Grade 3, 10.7% showed Grade 4. Actifit patients: 2 years: 20% of patients showed Grade 0, 44% showed Grade 1, 20% showed Grade 2, 16% showed Grade 3. | Therefore, there was no statistically significant evidence of degeneration over the follow-up period. | CMI patients: Genovese morphology: 61% patients Grade 2, 39% patients Grade 3, 1 case Grade 1 (complete resorption of the scaffold). Actifit patients: Genovese morphology: 79% patients Grade 2, 21% patients Grade 3. | CMI patients: Genovese signal intensity: 54% patients Grade 2A, 46% patients Grade 2B Actifit patients: Genovese signal intensity: 68% patients Grade 2A, 38% patients Grade 2B (number as stated in paper). |
Author | Year | Second Look Arthroscopy | Histology | Complications/Failure Rate |
---|---|---|---|---|
ACTIFIT | ||||
Bulgheroni [25] | 2013 | 9/19 patients had second look arthroscopy. Performed at 12M and 18M. 12M: scaffold was well integrated, reduced in size. 18M: scaffold was reduced in size compared to original scaffold, irregular margin. | 4M: new heterogenous tissue formed made up of fibroblastic cells 36M: the tissue was more organised Vessels were never found | Complication: knee stiffness in 1 patient with ACL reconstruction + scaffold Failure rate: 1/19 (5.3%). |
Dhollander [26] | 2016 | N/A | N/A | Failure rate: 14/44 (31.8%) |
Leroy [27] | 2017 | N/A | N/A | Complications: 3 complications Failure rate: 3/15 (20%) |
Schuttler [28] | 2015 | N/A | Complications: None. Failure rate: 0/18 (0%) | |
CMI | ||||
Bulgheroni [22] | 2010 | 8/34 patients had second look arthroscopy. Performed at either 7M (4 cases), 12M, 18M, 36M, 80M. All showed scaffold was well integrated, reduced in size compared to original scaffold. | Biopsies were taken for histological analysis during second look arthroscopy. 36M: meniscoid tissue with vasculogenesis 60M: fibres of the scaffold were completely absorbed. Two different connective tissues were observed - one more compact and the other looser | 2 complications: 1. suture tied with infrapatellar branch of the saphenous nerve 2. continuous swelling in knee Failure rate: 2/34 (5.8%) |
Zaffagnini [23] | 2011 | N/A | N/A | Complications: Swelling in 1 case and pain with swelling in 1 case. Failure rate: 2/17 (12%) |
Zaffagnini [24] | 2012 | N/A | N/A | Complications: No complications reported that were related to the implant. 1 patient had arthroscopic debridement 6 months after implantation as they reported knee pain and swelling. Failure rate: 1/24 (4%) |
ACTIFIT VS CMI | ||||
Bulgheroni [29] | 2016 | 7/28 CMI patients and 11/25 Actifit patients had second look arthroscopy. Performed at range of 4-45M. In all but 1, scaffold was well integrated, reduced in size compared to original scaffold, irregular margin. 1 CMI patient had complete resorption of scaffold. | CMI: fibrous tissue, vascular Actifit: fibrocartilaginous, avascular Both: developed over time, showed no signs of necrosis | CMI Group: 3 complications: neuro apraxia of infrapatellar branch of the saphenous nerve, persistent synovitis, superficial infection. Actifit Group: 5 complications: 1 case of joint stiffness, 4 cases of synovitis. Failure rate: not mentioned. |
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Ranmuthu, C.D.S.; Ranmuthu, C.K.I.; Russell, J.C.; Singhania, D.; Khan, W.S. Are the Biological and Biomechanical Properties of Meniscal Scaffolds Reflected in Clinical Practice? A Systematic Review of the Literature. Int. J. Mol. Sci. 2019, 20, 632. https://doi.org/10.3390/ijms20030632
Ranmuthu CDS, Ranmuthu CKI, Russell JC, Singhania D, Khan WS. Are the Biological and Biomechanical Properties of Meniscal Scaffolds Reflected in Clinical Practice? A Systematic Review of the Literature. International Journal of Molecular Sciences. 2019; 20(3):632. https://doi.org/10.3390/ijms20030632
Chicago/Turabian StyleRanmuthu, Chanuka D. S., Charindu K. I. Ranmuthu, Jodie C. Russell, Disha Singhania, and Wasim S. Khan. 2019. "Are the Biological and Biomechanical Properties of Meniscal Scaffolds Reflected in Clinical Practice? A Systematic Review of the Literature" International Journal of Molecular Sciences 20, no. 3: 632. https://doi.org/10.3390/ijms20030632