Human Amniotic Suspension Allograft Improves Pain and Function in Knee Osteoarthritis: A Prospective Not Randomized Clinical Pilot Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Human Amniotic Suspension Allograft Preparation
2.2. Statistical Analysis
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Inclusion Criteria | Exclusion Criteria |
---|---|
Age > 18 years old | Systemic cardiovascular and coagulation disorders or anticoagulant therapy |
Degenerative joint changes (KL 1–3) | Degenerative joint changes (KL 4)/surgical MRI findings |
Failure of previous conservative treatment (antiinflammatory, physical therapy, intra-articular steroid, viscosupplementation and platelet-rich plasma) | Intra-articular steroid or viscosupplementation injections performed within the last three months. |
History of chronic (≥4 months) pain or knee swelling with limitation of daily activities | Rheumatic diseases and septic knee arthritis |
Characteristics | Knee OA (N = 25) |
---|---|
Age (years) [Range] | 45.09 (15.31) [22–76] |
Sex (F/M) | 14/11 |
Body-Mass-Index (BMI), mean (SD) [range] | 22.86 (3.71) [17.9–36.5] |
Employment status (worker/retiree) | 18/7 |
Smoker, ex-smoker or non-smoker | 5/16/4 |
Previous surgery on affected knee (Meniscus surgery, osteotomy, cartilage procedure, arthroscopic debridement) | 9/16 |
Radiographic stage (Kellgren Lawrence) | |
Grade I | 5 |
Grade II | 15 |
Grade III | 5 |
Disease duration, years (SD) | 4.4 (2.3) |
Variable | Follow Up | Values | z Value | p | |
---|---|---|---|---|---|
IKDC Mean (SD) | PRE | 42.47 (11.44) | PRE versus 3 MO | −2.65 | 0.008 |
3 MO | 61.07 (15.3) | PRE versus 6 MO | −4.01 | 0.000 | |
6 MO | 71.97 (16.85) | PRE versus 12 MO | −3.18 | 0.001 | |
12 MO | 66.80 (25.43) | 3 MO versus 6 MO | −3.47 | 0.000 | |
6 MO versus 12 MO | −1.68 | 0.93 | |||
VAS Mean (SD) | PRE | 6.95 (1.70) | PRE versus 3 MO | −3.52 | 0.000 |
3 MO | 4.45 (1.95) | PRE versus 6 MO | −3.82 | 0.000 | |
6 MO | 3.67 (1.74) | PRE versus 12 MO | −3.41 | 0.000 | |
12 MO | 3.90 (2.19) | 3 MO versus 6 MO | −2.70 | 0.007 | |
6 MO versus 12 MO | −0.53 | 0.60 |
Variable | Follow up | ≤50 Years Old (N = 13) | >50 Years Old (N = 12) | p |
---|---|---|---|---|
IKDC Mean (SD) | PRE | 46.76 (11.59) | 36.28 (8.31) | 0.03 |
3 MO | 66.22 (13.80) | 52.7 (14.53) | 0.07 | |
6 MO | 74.7 (19.01) | 67.54 (12.46) | 0.48 | |
12 MO | 72.1 (26.11) | 58.2 (23.30) | 0.22 | |
VAS Mean (SD) | PRE | 6.62 (1.61) | 7.44 (1.81) | 0.22 |
3 MO | 4.15 (1.34) | 4.89 (2.62) | 0.49 | |
6 MO | 3.46 (1.45) | 4.00 (2.20) | 0.44 | |
12 MO | 3.31 (1.55) | 4.88 (2.80) | 0.23 |
Variable | Follow up | Previous Knee Surgery (N = 10) | Not Previous Knee Surgery (N = 15) | p |
---|---|---|---|---|
IKDC Mean (SD) | PRE | 38.83 (8.55) | 43.83 (12.82) | 0.36 |
3 MO | 63.87 (16.11) | 58.1 (14.68) | 0.65 | |
6 MO | 73.54 (16.10) | 68.97 (16.33) | 0.81 | |
12 MO | 69.53 (23.49) | 62.78 (26.24) | 0.71 | |
VAS Mean (SD) | PRE | 7.13 (1.81) | 6.86 (1.70) | 0.91 |
3 MO | 4.00 (1.51) | 4.71 (2.16) | 0.38 | |
6 MO | 3.29 (1.70) | 3.86 (1.79) | 0.42 | |
12 MO | 3.00 (1.41) | 4.36 (2.41) | 0.27 |
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Natali, S.; Farinelli, L.; Screpis, D.; Trojan, D.; Montagner, G.; Favaretto, F.; Zorzi, C. Human Amniotic Suspension Allograft Improves Pain and Function in Knee Osteoarthritis: A Prospective Not Randomized Clinical Pilot Study. J. Clin. Med. 2022, 11, 3295. https://doi.org/10.3390/jcm11123295
Natali S, Farinelli L, Screpis D, Trojan D, Montagner G, Favaretto F, Zorzi C. Human Amniotic Suspension Allograft Improves Pain and Function in Knee Osteoarthritis: A Prospective Not Randomized Clinical Pilot Study. Journal of Clinical Medicine. 2022; 11(12):3295. https://doi.org/10.3390/jcm11123295
Chicago/Turabian StyleNatali, Simone, Luca Farinelli, Daniele Screpis, Diletta Trojan, Giulia Montagner, Francesca Favaretto, and Claudio Zorzi. 2022. "Human Amniotic Suspension Allograft Improves Pain and Function in Knee Osteoarthritis: A Prospective Not Randomized Clinical Pilot Study" Journal of Clinical Medicine 11, no. 12: 3295. https://doi.org/10.3390/jcm11123295
APA StyleNatali, S., Farinelli, L., Screpis, D., Trojan, D., Montagner, G., Favaretto, F., & Zorzi, C. (2022). Human Amniotic Suspension Allograft Improves Pain and Function in Knee Osteoarthritis: A Prospective Not Randomized Clinical Pilot Study. Journal of Clinical Medicine, 11(12), 3295. https://doi.org/10.3390/jcm11123295