Abstract
Placental-derived tissues are a known source of anti-inflammatory and immune modulating factors. Published pilot data on amniotic suspension allograft (ASA) for the treatment of osteoarthritis (OA) demonstrated safety and trends for improved pain and function. A multicenter randomized controlled trial was designed to evaluate the efficacy of symptom modulation with ASA compared with saline and hyaluronic acid (HA) in subjects with knee OA. A total of 200 subjects were randomized 1:1:1 to ASA, HA, or saline, with subjects blinded to their allocation. Changes from baseline of patient-reported outcomes (PROs)-EQ-5D-5L, Knee Osteoarthritis Outcome Score (KOOS), visual analog scale (VAS), Tegner, and Single Assessment Numerical Evaluation (SANE)-were compared between groups. Patients reporting unacceptable pain at 3 months were considered treatment failures and withdrawn from the study. Statistical analysis was completed by comparing changes in PROs from baseline to 3 and 6 months for all groups. Comparison of demographics between treatment groups showed no significant differences between groups. Patients reporting unacceptable pain at 3 months in each group were ASA (13.2%), HA (68.8%), and saline (75%). Patients receiving ASA demonstrated significantly greater improvements from baseline for overall pain (VAS), KOOS pain, and KOOS-activities of daily living scores compared with those in the HA group (3 months) and both groups (6 months). ASA patients had significantly greater improvements in KOOS symptom scores compared with HA and saline at 3 and 6 months, respectively. OMERACT-OARSI responder rates for ASA, HA, and saline groups were 69.1, 39.1, and 42.6%, respectively (p = 0.0007). Subjects receiving ASA treatment showed greater improvements in PROs and fewer patients reported unacceptable pain compared with HA and saline. The evidence presented in this Level I Randomized Controlled Trial suggests that ASA injection is an effective treatment for the nonoperative management of symptomatic knee OA.
Highlights
Placental-derived tissues are a known source of anti-inflammatory and immune modulating factors
The hyaluronic acid (HA) treatment group consisted of 64 patients (31 females and 33 males) with a mean age of 55.4 Æ 11.0 years and a mean body mass index (BMI) of 28.2 Æ 4.7 kg/m2, and the normal saline group consisted of 68 patients (31 females and 37 males) with a mean age of 54.9 Æ 9.9 years and a mean BMI of 28.5 Æ 4.2 kg/m2
In subjects who reported acceptable pain relief, increases from baseline to 3 months were 17.64 Æ 1.91 and 9.99 Æ 1.50 for Knee Osteoarthritis Outcome Score (KOOS) pain and symptoms; for subjects who reported unacceptable pain relief, scores changed by 0.16 Æ 1.89 and À0.04 Æ 1.50, respectively (p < 0.0001 for the difference between the groups reporting acceptable versus unacceptable pain relief, for both KOOS subscales)
Summary
Placental-derived tissues are a known source of anti-inflammatory and immune modulating factors. Subjects receiving ASA treatment showed greater improvements in PROs and fewer patients reported unacceptable pain compared with HA and saline. Approaches include nonsteroidal anti-inflammatory drugs, physical therapy, hyaluronic acid (HA), and corticosteroids, among others.[7,8,9] Intra-articular (IA) injections of corticosteroids have been utilized for years in the treatment of symptomatic knee OA with short-term effectiveness (1 week–3 months)[10]; in a study by McAlindon et al, repeated injections over 2 years demonstrated small but potentially concerning long-term detrimental effects.[11] despite reasonable clinical experience with various HA formulations, the AAOS has recently recommended against the use of HA in their AAOS CPGs since overall improvements were reported not to meet the minimum clinically important improvement thresholds.[6]. Despite appropriate conservative care efforts, a significant number of patients will remain symptomatic These patients may not be candidates for total knee replacement due to having disease that is not end-stage yet, medical frailty, obesity, young age, high activity level, or because they wish to avoid surgery. There remains a lack of high-level, peer-reviewed studies on the efficacy of amniotic tissue for the treatment of symptomatic knee OA
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