Long-Term Outcome Measures of Repeated Non-Animal Stabilized Hyaluronic Acid (Durolane) Injections in Osteoarthritis: A 6-Year Cohort Study with 623 Consecutive Patients

Figures & data

Table 1 Demographic Data

Patients, Total 623	Mean ± SD (Range)
Age at first injection, years	57.8 ± 12.7 (21.2–92.1)
Male, n (%)	297 (47.7%)
Joints, total 727 n (%)
Knee	326 (44.8%)
Hip	387 (53.2%)
Shoulder	12 (1.7%)
Ankle	2 (0.3%)
Kellgren Lawrence grade at first injection, n (%)	2.9 ± 0.80 (2–4)
2	292 (40.2%)
3	247 (33.9%)
4	188 (25.9%)
Number of injections done at each joint, total 987	1.5 ± 0.96 (1–8)

Notes: The values are expressed as mean ± SD or n (%).

Abbreviation: n, number; SD, standard deviation.

Table 2 Average Time Gap Between HA Injections in Days

Injection	Joints, n	Mean ± SD	Range	95% CI	p-Value
1st	727	–		–	–
2nd	157	466.8 ± 321.7	31–1831	416.1–517.5	<0.0001
3rd	58	400.5 ± 164.7	132–875	357.2–443.8	<0.0001
4th	27	378.2 ± 223.1	148–1162	289.9–466.4	0.0001
5th	7	405.3 ± 216.3	189–844	205.2–605.3	0.0341
6th	5	268.4 ± 104.4	141–406	138.8–398.0	0.1379
7th	4	289.8 ± 99.4	212–435	131.6–447.9	0.1186
8th	2	272.5 ± 33.2	249–296	−26.1–571.1	0.1617

Notes: The values are expressed in days, unless indicated otherwise. The null hypothesis was set at 182 days (26 weeks or 6 months) in line with previous clinical trial reports that non-animal stabilized HA is effective up to this point.⁹ P-values were considered statistically significant if less than the significance level 0.05.

Abbreviations: n, number; SD, standard deviation; CI, confidence interval.

Figure 1 Graph of duration of symptom relief in days for each injection. x-axis = injection number, y-axis = days.

Table 3 Average Time Joints Returned for a 2nd HA Injection, in Days, Stratified by Group

Group	Joints, n	Mean ± SD	df	F	p-Value
Joint Injected
Knee	82	507.5 ± 345.0	2, 154	1.41	0.2480
Hip	73	423.5 ± 293.0
Shoulder	2	375.5 ± 174.7
Age
<40	6	399 ± 168.4	4, 152	1.08	0.3697
40–49	23	455.3 ± 317.3
50–59	62	507.7 ± 396.4
60–69	46	479.8 ± 251.4
>70	20	343.7 ± 219.0
Gender
Male	73	447.1 ± 327.5	1, 155	0.51	0.4763
Female	84	483.9 ± 317.5
KL grade
2	60	515 ± 340.4	2, 154	3.53	0.0316
3	57	496.0 ± 357.6
4	40	352.8 ± 192.1

Notes: The values are expressed in days, unless indicated otherwise.

Abbreviations: n, number; SD, standard deviation; df, degrees of freedom.

Table 4 Tukey’s Comparison of Average Time Between Injections, in Days, for KL Grade

KL Grade	Difference	Standard Error	95% CI	p-Value
3 vs 2	−6.95	39.3	−99.6–85.7	0.983
4 vs 2	−107.8	43.7	−211.0 – −4.7	0.038
4 vs 3	−100.9	44.6	−206.1–4.3	0.063

Notes: The values are expressed in days, unless indicated otherwise.

Abbreviations: KL, Kellgren Lawrence; CI, confidence interval.

Figure 2 Flow of patients through post-treatment experience and satisfaction survey.

Abbreviation: n, number of participants.

Table 5 Patient Experience and Satisfaction with HA Treatment Survey Results

Patients, Total 233	1st Injection	2nd Injection	>3 Injections
	233 Patients	98 Patients	46 Patients
Thinking about your FIRST, SECOND and/or any FURTHER Durolane injections: Did you receive significant relief from your OA symptoms following this injection?
Yes	151 (64.8%)	79 (80.6%)	34 (73.9%)
No	82 (35.2%)	18 (18.4%)	5 (10.9%)
Open-text response	–	–	7 (15.2%)
If yes, how long did you feel this relief lasted?
Less than 1 month	6 (4.0%)	6 (7.6%)	1 (2.9%)
1–3 months	9 (6.0%)	9 (11.4%)	6 (17.6%)
3–6 months	21 (13.9%)	8 (10.1%)	1 (2.9%)
6–9 months	23 (15.2%)	17 (21.5%)	4 (11.8%)
9–12 months	24 (15.9%)	18 (22.8%)	11 (32.4%)
12–18 months	30 (19.9%)	13 (16.5%)	7 (20.6%)
More than 18 months	38 (25.1%)	8 (10.1%)	4 (11.8%)
Did you receive any other treatments (such as surgery, physiotherapy or other injections) for your OA? (Number of patients responding to this question, 226)*
Yes	150 (66.4%)
No	76 (33.6%)
If yes, what other treatments did you received? *
Arthroscopy	33 (22%)
Corticosteroid injection	18 (12%)
Joint replacement	77 (51.3%)
nSTRIDE	6 (4%)
Other biological	5 (3%)
Physiotherapy	58 (38.7%)
PRP injection	17 (11.3%)
Strength based program	32 (21.3%)
Based on your experience, would you recommend this treatment for OA? (Number of patients responding to this question, n=222)
Yes	144 (64.9%)
No	78 (35.1%)
Is there any other feedback you would like to give (patients responding to this question, n=222)
Feedback given	136 (61.3%)
No further comments made	87 (39.2%)

Notes: The values are expressed as n (%) unless indicated otherwise. *Patients were able to tick more than one option so the sum of percentages may be more than 100%.

Abbreviation: n, number.

Leighton R, Fitzpatrick J, Smith H, Crandall D, Flannery C, Conrozier T. Systematic clinical evidence review of NASHA (Durolane hyaluronic acid) for the treatment of knee osteoarthritis. Open Rheumatol J. 2018;10:43–54.

 Google Scholar