The Therapeutic Effect of Intra-articular Normal Saline Injections for Knee Osteoarthritis: A Meta-analysis of Evidence Level 1 Studies

Saltzman, Bryan M.; Leroux, Timothy; Meyer, Maximilian A.; Basques, Bryce A.; Chahal, Jaskarndip; Bach, Bernard R.; Yanke, Adam B.; Cole, Brian J.

doi:10.1177/0363546516680607

Cited by 121 publications

(118 citation statements)

References 38 publications

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“…However, recent reviews of the published literature suggest potential benefits of saline that extend beyond a pure placebo effect. 29,30 It has been hypothesized that saline may exert beneficial effects by reducing proinflammatory cells and molecules and provide temporary pain relief. 29 In a meta-analysis by Saltzman et al, 14 placebo cohorts over 13 studies were evaluated.…”

Section: Discussionmentioning

confidence: 99%

A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms

et al. 2019

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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 Patients reporting unacceptable pain at 3 months were considered treatment failures and withdrawn from the study.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.

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Section: Discussionmentioning

confidence: 99%

A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms

et al. 2019

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“…Results revealed substantial pain relief in both BMAC and saline treated knees; however, there was no statistically significant difference between the groups. This study is often cited as evidence against the use of autologous BMAC; however, limitations to this study include short follow-up period, low number of patients, high variability in MSCs and effector cells that were injected, possible systemic effects of MSCs that may have affected the saline injected knee, as well as the fact that normal saline is not a true placebo as multiple level I studies have described the therapeutic effects of intra-articular normal saline injections for knee OA [34]. The Shapiro study does further expand the research demonstrating that autologous BM-derived orthobiologics are safe and can provide significant pain relief in knee OA, but highlights the need for further studies in the field.…”

Section: Discussionmentioning

confidence: 99%

Functional Outcomes Following Microfragmented Adipose Tissue Versus Bone Marrow Aspirate Concentrate Injections for Symptomatic Knee Osteoarthritis

Mautner

Bowers

Easley

et al. 2019

Stem Cells Translational Medicine

135

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This study aimed to determine whether autologous orthobiologic tissue source affects pain and functional outcomes in patients with symptomatic knee osteoarthritis (OA) who received microfragmented adipose tissue (MFAT) or bone marrow aspirate concentrate (BMAC) injection. We retrospectively reviewed prospectively collected data from patients who received BMAC or MFAT injection for symptomatic knee OA. Patients completed baseline and follow‐up surveys. Each survey included the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire, Emory Quality of Life (EQOL) questionnaire, and Visual Analog Scale (VAS) for pain. The follow‐up responses were compared with baseline for all patients and between BMAC and MFAT groups. A total of 110 patients met inclusion criteria, with 76 patients (BMAC 41, MFAT 35) and 106 knees (BMAC 58, MFAT 48) having appropriate follow‐up data. The BMAC group included 17 females and 24 males, with a mean age of 59 ± 11 years. The MFAT group included 23 females and 12 males, with a mean age of 63 ± 11 years. Minimum follow‐up time was 0.5 years. Mean follow‐up time was 1.80 ± 0.88 years for BMAC and 1.09 ± 0.49 years for MFAT. Both groups had significant improvement in EQOL, VAS, and all KOOS parameters preprocedure versus postprocedure (p < .001). There was not a significant difference when comparing postprocedure scores between groups (p = .09, .38, .63, .94, .17, .15, .70, respectively). These data demonstrate significant improvement in pain and function with both MFAT and BMAC injections in patients with symptomatic knee OA without a significant difference in improvement when comparing the two autologous tissue sources. Stem Cells Translational Medicine 2019;8:1149–1156

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“…The results also supported preliminary favourable outcomes in terms of pain reduction, improvement of function, and better pain experience and quality of life in participants with KOA. Despite the small sample size, the improvement in the WOMAC total score of 13.30 exceeded the effect of the control injection of intra-articular normal saline (11.34) [37], and exceeded the minimal clinically important difference of 12 points in rehabilitation intervention for KOA [38].…”

Section: Discussionmentioning

confidence: 81%

Intra-articular and extra-articular platelet-rich plasma injections for knee osteoarthritis: A 26-week, single-arm, pilot feasibility study

Sit

Wu²,

Law

et al. 2019

The Knee

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Aim: Platelet Rich Plasma (PRP) is an emerging therapy for knee osteoarthritis (KOA). Studies have evaluated the effectiveness of intra-articular PRP, which ignores extra-articular tissue dysfunction and may provide incomplete treatment of KOA. The study aimed to pilot test a leukocyte-rich (mononuclear cells) PRP injection protocol for primary KOA, which consisted of single intra-articular injection and extra-articular injections on the medial coronary and medial collateral ligaments.Methods: A prospective 26-week single-arm uncontrolled feasibility pilot study. Patients (N = 12) with primary KOA as defined by the American Rheumatology Association, with moderate to severe medial knee pain which failed conservative management, were recruited in a university primary care clinic and received a single session of PRP injection in week 1. The primary outcome was the feasibility of the protocol at 26 weeks as defined by rates of recruitment, compliance, retention, dropout, side effects or adverse events; and treatment satisfaction. Secondary outcomes included the Western Ontario McMaster University Osteoarthritis Index, the Intermittent and Constant Osteoarthritis Pain total and subscales, objective physical function tests and EuroQol-5D.Results: Twelve of 40 potential patients were recruited in 3 months period (recruitment rate 30%, x2 = 3.33, P = 0.068). All participants adhered to the protocol and completed the follow up assessment with no dropouts (dropout rate 0%, X2= 2.67, P = 0.103). Satisfaction was high; no related adverse events were reported. Most secondary outcomes showed statistically significant improvement. Conclusions:Concomitant intra-articular and extra-articular PRP injections were feasible and produced preliminary favourable outcomes.

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The Therapeutic Effect of Intra-articular Normal Saline Injections for Knee Osteoarthritis: A Meta-analysis of Evidence Level 1 Studies

Cited by 121 publications

References 38 publications

A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms

A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms

Functional Outcomes Following Microfragmented Adipose Tissue Versus Bone Marrow Aspirate Concentrate Injections for Symptomatic Knee Osteoarthritis

Intra-articular and extra-articular platelet-rich plasma injections for knee osteoarthritis: A 26-week, single-arm, pilot feasibility study

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