Clinical Study

Polymerized-Type I Collagen Downregulates Inflammation and Improves Clinical Outcomes in Patients with Symptomatic Knee Osteoarthritis Following Arthroscopic Lavage: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial

Table 2

Clinical characteristics of the patients.

Placebo ( 𝑛 = 9 )Polymerized-type I collagen ( 𝑛 = 1 0 )
Baseline3 months6 monthsBaseline3 months6 months

Patient pain (mm); mean ± SD7.5 ± 1.24.8 ± 3.15.5 ± 2.37.2 ± 2.32.6 ± 2.52.7 ± 2.3
Median8.04.05.58.01.72.0
Range(6.0–9.0)(1.0–9.0)(1.0–8.5)(4.0–10.0)(0.5–7.8)(0.0–6.5)
Physician pain (mm); mean ± SD7.6 ± 1.53.4 ± 3.05.1 ± 2.37.6 ± 1.82.7 ± 2.92.8 ± 2.1
Median8.02.04.88.01.92.0
Range(5.5–9.0)(1.0–9.1)(1.0–8.0)(4.0–10.0)(0.0–8.0)(0.0–6.0)
Lequesne; mean ± SD13.1 ± 3.011.6 ± 4.012.9 ± 3.312.8 ± 2.77.3 ± 1.96.2 ± 3.6
Median14.011.013.013.07.57.0
Range(8.0–18.0)(6.0–19.0)(9.0–19.0)(8.0–16.0)(4.0–10.0)(1.0–12.0)
WOMAC pain subscale; mean ± SD11.2 ± 3.67.1 ± 3.78.2 ± 3.911.1 ± 4.15.8 ± 2.84.0 ± 3.0
Median10.07.08.010.54.53.0
Range(6.0–19.0)(1.0–12.0)(3.0–15.0)(7.0–19.0)(3.0–11.0)(0.0–8.0)
WOMAC stiffness subscale; mean ± SD3.9 ± 1.93.2 ± 2.03.7 ± 2.03.6 ± 2.62.4 ± 1.91.9 ± 1.7
Median4.02.05.03.52.02.0
Range(0.0–7.0)(0.0–6.0)(0.0–6.0)(1.0–8.0)(0.0–6.0)(0.0–4.0)
WOMAC disability subscale; mean ± SD37.1 ± 15.626.3 ± 17.226.4 ± 14.741.0 ± 14.219.0 ± 12.615.2 ± 11.6
Median43.022.026.037.020.521.0
Range(11.0–56.0)(2.0–58.0)(6.0–50.0)(27.0–68.0)(4.0–35.0)(0.0–33.0)
Patient Likert score (cm); mean ± SD1.1 ± 0.82.1 ± 1.12.1 ± 0.91.2 ± 0.62.8 ± 0.92.7 ± 0.7
Median1.02.02.01.03.03.0
Range(0.0–2.0)(1.0–4.0)(1.0–3.0)(0.0–2.0)(1.0–4.0)(2.0–4.0)
Physician Likert score (cm); mean ± SD1.0 ± 0.82.3 ± 1.02.5 ± 0.91.5 ± 0.73.1 ± 0.43.1 ± 0.6
Median1.02.02.52.03.03.0
Range(0.0–2.0)(1.0–4.0)(1.0–4.0)(0.0–2.0)(3.0–4.0)(2.0–4.0)
Patient drug evaluation (cm); mean ± SD2.4 ± 1.02.1 ± 0.82.9 ± 0.63.1 ± 0.6
Median3.02.03.03.0
Range(1.0–4.0)(1.0–3.0)(2.0–4.0)(2.0–4.0)
Physician drug evaluation (cm); mean ± SD2.1 ± 1.42.3 ± 1.02.9 ± 0.43.1 ± 0.6
Median2.02.53.03.0
Range(0.0–4.0)(0.0–3.0)(2.0–3.0)(2.0–4.0)
Analgesic usage (tablets day−1); mean ± SD40.4 ± 17.153.3 ± 20.071.1 ± 38.640.4 ± 17.113.0 ± 10.97.0 ± 4.9
Median30.060.060.030.012.07.0
Range(16.0–60.0)(30.0–90.0)(30.0–150.0)(16.0–60.0)(0.0–30.0)(0.0–14.0)