Background
Methods
Study design and patients
Inclusion criteria
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ambulatory adult patients affected by knee OA
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diagnosis according to the ARA (American Rheumatism Association) criteria
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age > 40 years
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disease activity assessed by the Lequesne Knee Index ≥ 7.0 at T0
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disease activity assessed according to the VAS at T0 ≥ 4 cm and persistence of pain in the knee for at least the last 3 months.
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radiological degree II-III according to the Kellgren-Lawrence scale
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patients able to comply with study procedures.
Exclusion criteria
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presence of comorbidities (rheumatoid arthritis, spondyloarthritis, connective tissue disease, polymyalgia rheumatica, gout, Paget’s disease, septic arthritis, fractures, osteonecrosis, and fibromyalgia)
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patients with skin or subcutaneous tissue infection in the area of the joint to be treated
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patients who had used oral, parenteral or intra-articular corticosteroids in the 3 months prior to the T0 visit
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patients taking topical analgesics that may interfere with the evaluation of the study
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patients on anticoagulant therapy or suffering from thrombocytopenia and/or coagulopathy
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patients with allergy to products of porcine origins.
Primary endpoint
Secondary endpoints
Rescue medication
Reporting adverse events
Statistical methods
Results
Group A (MD-Knee) = 32 | Group B (SUPARTZ®) = 32 | |
---|---|---|
Age (years ± SD) | 69.41 ± 8.42 | 69.97 ± 9.5 |
Women, n (%) | 25 (86.2 %) | 20 (64.5 %) |
BMI (kg/m2) | 27.20 ± 3.78 | 27.3 ± 3.56 |
Kellgren and Lawrence, n (%)Grade II (%) | 15 (51 %) | 17 (55 %) |
Kellgren and Lawrence, n (%)Grade III (%) | 14 (49 %) | 14 (45 %) |
LKI ± SD | 12.48 ± 2.63 | 12.6 ± 3.48 |
SF36 ± SD | 91.41 ± 20.01 | 93.07 ± 17.3 |
Pain VAS (cm) ± SD | 7.67 ± 1.41 | 7.42 ± 1.35 |
Primary endpoint
Non-inferiority of LKI score at T3FU
T3 FU | T6 FU | |||||
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Group A (MD-Knee) | Group B (SUPARTZ®) | P-value | Group A (MD-Knee) | Group B (SUPARTZ®) | P-value | |
LKI ± SD | 8.59 ± 4.71 | 9.79 ± 4.43 | 0.33 | 9.12 ± 3.89 | 9.28 ± 4.28 | 0.621 |
Pain VAS ± SD | 5.26 ± 2.52 | 5.13 ± 2.41 | NE | 5.42 ± 2.69 | 4.43 ± 2.63 | 0.275 |
SF36 ± SD | 99.15 ± 8.95 | 101.32 ± 6.37 | NE | 88.37 ± 28.83 | 92.07 ± 23.37 | 0.462 |
Secondary endpoints
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LKI variation inter- groups at T0 versus T6FU
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Pain VAS
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SF36 questionnaire
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Pain Killer consumption (Rescue Medication)Including dropouts, Acetaminophen was used by 13 of 29 patients (44,8 %) in Group A (MD-Knee) and by 12 of 31 patients (38,7 %) in Group B (SUPARTZ®). Acetominophen consumption during the trial did not change in the two Groups, considering both “only users” and “all patients” (Mann–Whitney test U: p = 0.2198 e p = 0.9348, respectively). Fig. 5a, b.×