Clinical Efficacy and Safety of Two Cycles of Intra-Articular Injection of Porcine Atelocollagen Versus Hyaluronic Acid in Knee Osteoarthritis
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design and Ethical Approval
2.2. Participants and Eligibility Criteria
2.3. Interventions and Injection Protocol
2.4. Follow-Up Schedule and Outcome Measures
2.5. Statistical Analysis
3. Results
3.1. Baseline Characteristics
3.2. Primary Outcome: Non-Inferiority of VAS and WOMAC Score Changes
3.3. Secondary Outcome: VAS and WOMAC Scores
3.4. Patient Satisfaction
3.5. Adverse Events
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
CI | confidence interval |
KOA | knee osteoarthritis |
MCID | minimal clinically important difference |
NSAIDs | non-steroidal anti-inflammatory drugs |
OA | osteoarthritis |
SCB | substantial clinical benefit |
SD | standard deviation |
SYSADOAs | symptomatic slow-acting drugs for osteoarthritis |
VAS | visual analog scale |
WOMAC | the Western Ontario and McMaster Universities Osteoarthritis Index |
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Collagen | Hyaluronic Acid | p-Value | |
---|---|---|---|
Age, years | 67.3 ± 10.3 | 69.0 ± 9.0 | 0.737 |
Sex, female/male, n | 15/5 | 16/4 | 1 |
BMI, kg/m2 | 23.5 ± 3.8 | 24.8 ± 3.2 | 0.257 |
Occupation (n, %) | 0.305 | ||
Housewife | 10 (50%) | 14 (70%) | |
White collar job | 4 (20%) | 1 (5%) | |
Pink-collar job | 2 (10%) | 0 (0%) | |
Blue-collar job | 0 (0%) | 3 (15%) | |
Inoccupation | 4 (20%) | 2 (10%) | |
Kellgren–Lawrence OA grade | 2.8 ± 1.0 | 2.35 ± 0.99 | 0.151 |
II (n, %) | 7 (35%) | 10 (50%) | 0.337 |
III (n, %) | 13 (65%) | 10 (50%) | |
Previous medication history (n, %) | 0.500 | ||
NSAIDs | 12 (60%) | 10 (50%) | |
NSAIDs + SYSADOAs | 6 (30%) | 9 (45%) | |
NSAIDs + SYSADOAs + Analgesics | 2 (10%) | 1 (5%) | |
Previous injection history (n, %) | 0.100 | ||
Yes | 11 (55%) | 6 (30%) | |
No | 9 (45%) | 14 (70%) | |
Injection site (Rt, %) | 14 (70%) | 18 (90%) | 0.235 |
Underlying disease (n, %) | |||
Hypertension | 11 (55%) | 10 (50%) | 0.751 |
Diabetes | 4 (20%) | 5 (25%) | 1 |
Thyroid disease | 4 (20%) | 0 (0%) | 0.106 |
Smoking (n, %) | 6 (30%) | 6 (30%) | 1 |
Pre-injection | |||
VAS resting | 4.8 ± 2.5 | 4.6 ± 3.0 | 0.776 |
VAS walking | 6.5 ± 2.1 | 6.9 ± 2.0 | 0.538 |
VAS night | 3.3 ± 3.3 | 2.1 ± 2.5 | 0.299 |
Total WOMAC | 48.9 ± 14.9 | 45.7 ± 20.6 | 0.583 |
Pain WOMAC | 9.7 ± 4.0 | 8.6 ± 4.4 | 0.438 |
Stiffness WOMAC | 5.5 ± 2.1 | 4.8 ± 2.2 | 0.281 |
Function WOMAC | 33.7 ± 10.3 | 32.4 ± 15.3 | 0.745 |
Collagen | Hyaluronic Acid | Non-Inferiority Test (Margin: VAS = 1.99) | ||
---|---|---|---|---|
p-Value | 95% CI | |||
Pre-injection–1st injection | ||||
VAS resting | 2.3 ± 2.0 | 2.4 ± 2.2 | 0.004 | (−1.218, ∞) |
VAS walking | 3.0 ± 2.5 | 3.2 ± 2.1 | 0.010 | (−1.433, ∞) |
VAS night | 1.8 ± 2.3 | 1.1 ± 1.4 | <0.0001 | (−0.312, ∞) |
Pre-injection–2nd injection | ||||
VAS resting | 3.1 ± 2.1 | 3.3 ± 2.6 | 0.011 | (−1.459, ∞) |
VAS walking | 4.4 ± 2.4 | 4.7 ± 2.5 | 0.019 | (−1.635, ∞) |
VAS night | 2.4 ± 2.6 | 1.6 ± 2.0 | 0.0003 | (−0.440, ∞) |
Collagen | Hyaluronic Acid | Non-Inferiority Test (Margin: WOMAC = MCID) | Non-Inferiority Test (Margin: WOMAC = SCB) | |||
---|---|---|---|---|---|---|
p-Value | 95% CI | p-Value | 95% CI | |||
Pre-injection–1st injection | ||||||
Total WOMAC | 24.3 ± 11.0 | 20.1 ± 10.4 | <0.0001 | (−1.502, ∞) | <0.0001 | (−1.502, ∞) |
Pain WOMAC | 4.8 ± 2.6 | 4.0 ± 2.6 | <0.0001 | (−0.634, ∞) | <0.0001 | (−0.634, ∞) |
Stiffness WOMAC | 2.5 ± 1.7 | 1.8 ± 1.3 | <0.0001 | (−0.043, ∞) | <0.0001 | (−0.043, ∞) |
Function WOMAC | 16.5 ± 7.8 | 14.2 ± 7.3 | <0.0001 | (−1.724, ∞) | <0.0001 | (−1.724, ∞) |
Pre-injection–2nd injection | ||||||
Total WOMAC | 33.2 ± 12.8 | 27.6 ± 14.9 | <0.0001 | (−1.858, ∞) | <0.0001 | (−1.858, ∞) |
Pain WOMAC | 6.8 ± 3.1 | 5.4 ± 3.4 | <0.0001 | (−0.384, ∞) | <0.0001 | (−0.384, ∞) |
Stiffness WOMAC | 3.1 ± 1.9 | 2.5 ± 1.9 | <0.0001 | (−0.372, ∞) | <0.0001 | (−0.372, ∞) |
Function WOMAC | 23.2 ± 8.9 | 19.7 ± 10.5 | <0.0001 | (−1.651, ∞) | <0.0001 | (−1.651, ∞) |
Collagen | Hyaluronic Acid | p-Value | |
---|---|---|---|
Six months after the 1st injection | 0.752 | ||
No change (n, %) | 0(0%) | 0(0%) | |
Slightly improved (n, %) | 9(45%) | 10(50%) | |
Very improved (n, %) | 11(55%) | 10(50%) | |
Six months after the 2nd injection | 0.889 | ||
No change (n, %) | 2(10%) | 3(15%) | |
Slightly improved (n, %) | 15(75%) | 14(70%) | |
Very improved (n, %) | 3(15%) | 3(15%) |
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In, Y.; Choi, K.Y.; Kim, M.S. Clinical Efficacy and Safety of Two Cycles of Intra-Articular Injection of Porcine Atelocollagen Versus Hyaluronic Acid in Knee Osteoarthritis. Bioengineering 2025, 12, 710. https://doi.org/10.3390/bioengineering12070710
In Y, Choi KY, Kim MS. Clinical Efficacy and Safety of Two Cycles of Intra-Articular Injection of Porcine Atelocollagen Versus Hyaluronic Acid in Knee Osteoarthritis. Bioengineering. 2025; 12(7):710. https://doi.org/10.3390/bioengineering12070710
Chicago/Turabian StyleIn, Yong, Keun Young Choi, and Man Soo Kim. 2025. "Clinical Efficacy and Safety of Two Cycles of Intra-Articular Injection of Porcine Atelocollagen Versus Hyaluronic Acid in Knee Osteoarthritis" Bioengineering 12, no. 7: 710. https://doi.org/10.3390/bioengineering12070710
APA StyleIn, Y., Choi, K. Y., & Kim, M. S. (2025). Clinical Efficacy and Safety of Two Cycles of Intra-Articular Injection of Porcine Atelocollagen Versus Hyaluronic Acid in Knee Osteoarthritis. Bioengineering, 12(7), 710. https://doi.org/10.3390/bioengineering12070710