Incidence of total knee replacement subsequent to intra-articular injection of the anti-inflammatory compound LMWF-5A versus saline: A long-term follow-up study to a randomized controlled trial

被引：8
作者：
Schwappach J. [1 ]
Schultz J. [1 ]
Salottolo K. [2 ]
Bar-Or D. [2 ,3 ]
机构：
[1] Denver Metro Orthopedics, P.C, Englewood, 80113, CO
[2] Trauma Research Department, Swedish Medical Center, 501 E. Hampden Ave, Englewood, 80113, CO
[3] Ampio Pharmaceuticals, Inc, 373 Inverness Parkway, Englewood, 80112, CO
来源：
Patient Safety in Surgery | / 12卷 / 1期
关键词：
Kellgren-Lawrence grade; Osteoarthritis; Total knee replacement;
D O I：
10.1186/s13037-018-0162-4
中图分类号：
学科分类号：
摘要：
Background: The disease modifying potential of osteoarthritis therapies are of increasing interest, including their effects on delaying total knee replacement (TKR). To date, there have been no studies to determine the effect of LMWF-5A, a novel anti-inflammatory compound derived from human serum albumin, on delaying TKR. Methods: We evaluated time to TKR three years after patients participated in a randomized trial of three intra-articular injections of LMWF-5A or saline. Patients were contacted via last known phone number and were asked to participate in a short nine item telephone questionnaire; verbal consent was obtained. The primary endpoint was incidence of TKR (%). Results: In total, 39 of 45 patients responded (87% response rate). The overall incidence of TKR was 38.5% (15/39). TKR rates were higher in patients with more severe osteoarthritis defined by Kellgren-Lawrence grade 4, compared to patients with moderate osteoarthritis defined by Kellgren-Lawrence grade 3 (56% vs. 26%, p = 0.06). Overall, there were no differences in TKR rates by treatment arm (39% LMWF-5A vs. 38% saline, p = 0.92). In the severe osteoarthritis subset (n = 16), treatment with LMWF-5A resulted in a lower incidence of TKR compared to saline vehicle arm (40% vs. 83%, p = 0.15). TKR rates were significantly lower with LMWF-5A in patients who responded to treatment (14% with LMWF-5A, vs. 100% with saline, p = 0.03). Conclusion: This study demonstrates significant delays in TKR for patients with severe osteoarthritis treated with LMWF-5A, suggesting that LMWF-5A has the potential to provide structure modifying/preserving therapy in this population. © 2018 The Author(s).
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共 16 条
[1]  
Murphy L., Schwartz T.A., Helmick C.G., Renner J.B., Tudor G., Koch G., Et al., Lifetime risk of symptomatic knee osteoarthritis, Arthritis Rheum, 59, pp. 1207-1213, (2008)
[2]  
Davies-Tuck M.L., Wluka A.E., Wang Y., Teichtahl A.J., Jones G., Ding C., Et al., The natural history of cartilage defects in people with knee osteoarthritis, Osteoarthr Cartil, 16, pp. 337-342, (2008)
[3]  
Felson D.T., Anderson J.J., Boers M., Bombardier C., Furst D., Goldsmith C., Et al., American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis, Arthritis Rheum, 38, pp. 727-735, (1995)
[4]  
Kellgren J.H., Lawrence J.S., Radiological assessment of osteo-arthrosis, Ann Rheum Dis, 16, pp. 494-502, (1957)
[5]  
Kurtz S., Ong K., Lau E., Mowat F., Halpern M., Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030, J Bone Joint Surg Am, 89, pp. 780-785, (2007)
[6]  
Bruyere O., Pavelka K., Rovati L.C., Gatterova J., Giacovelli G., Olejarova M., Et al., Total joint replacement after glucosamine sulphate treatment in knee osteoarthritis: results of a mean 8-year observation of patients from two previous 3-year, randomised, placebo-controlled trials, Osteoarthr Cartil, 16, pp. 254-260, (2008)
[7]  
F.J Blanco J.-S., Pinto-Tasende J.A., Fernandez-Lopez J.C., Ramallal M., Freire A., Galdo F., Intra-articular Hyaluronan treatment of patients with knee osteoarthritis waiting for replacement surgery, Open Arthritis Journal, 1, pp. 1-7, (2008)
[8]  
Raynauld J.P., Martel-Pelletier J., Dorais M., Haraoui B., Choquette D., Abram F., Et al., Total knee replacement as a knee osteoarthritis outcome: predictors derived from a 4-year long-term observation following a randomized clinical trial using chondroitin sulfate, Cartilage, 4, pp. 219-226, (2013)
[9]  
Bar-Or D., Salottolo K.M., Loose H., Phillips M.J., McGrath B., Wei N., Et al., A randomized clinical trial to evaluate two doses of an intra-articular injection of LMWF-5A in adults with pain due to osteoarthritis of the knee, PLoS One, 9, (2014)
[10]  
Cole B., McGrath B., Salottolo K., Bar-or D., LMWF-5A for the treatment of severe osteoarthritis of the knee: integrated analysis of safety and efficacy, Orthopedics, 41, 1, pp. e77-e83, (2018)
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