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

Volumn 9, Issue 2, 2014, Pages

  Bar Or, David ^a,b,c,d   Salottolo, Kristin M ^a,b,c   Loose, Holli ^c   Phillips, Matthew J ^e   McGrath, Brian ^e   Wei, Nathan ^f   Borders, James L ^g   Ervin, John E ^h   Kivitz, Alan ⁱ   Hermann, Mark ^j   Shlotzhauer, Tammi ^k   Churchill, Melvin ^l   Slappey, Donald ^m   Clift, Vaughan ^c  

^a SWEDISH MEDICAL CENTER   (United States)

^b ST ANTHONY HOSPITAL   (United States)

^c Ampio Pharmaceuticals Inc   (United States)

^d ROCKY VISTA UNIVERSITY   (United States)

^e University Orthopaedic Center   (United States)

^f Arthritis Treatment Center   (United States)

^g Central Kentucky Res Assoc Inc   (Israel)

^h Center for Pharmaceutical Research   (United States)

ⁱ Altoona Center for Clinical Research   (United States)

^j Danville Orthopedic Clinic   (United States)

^k Rochester Medical Corporation   (United States)

^l Physician Research Collaboration   (United States)

^m Alabama Clinical Therapeutics   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN SERUM ALBUMIN; SERUM ALBUMIN;

ADULT; AGED; ARTHRALGIA; ARTICLE; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; FEMALE; HEADACHE; HUMAN; INJECTION SITE PAIN; JOINT STIFFNESS; JOINT SWELLING; KELLGREN LAWRENCE GRADE; KNEE FUNCTION; KNEE OSTEOARTHRITIS; KNEE PAIN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MUSCLE SPASM; MUSCULOSKELETAL PAIN; MYALGIA; NAUSEA; OSTEOARTHRITIS; PARALLEL DESIGN; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; UNSPECIFIED SIDE EFFECT; URTICARIA; WESTERN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX; CONTROLLED CLINICAL TRIAL; INTERVENTION STUDY; INTRAARTICULAR DRUG ADMINISTRATION; MIDDLE AGED; MOLECULAR WEIGHT; PAIN; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INJECTIONS, INTRA-ARTICULAR; INTERVENTION STUDIES; MALE; MIDDLE AGED; MOLECULAR WEIGHT; OSTEOARTHRITIS, KNEE; PAIN; SERUM ALBUMIN; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 84896838199     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0087910     Document Type: Article

References (31)

1. Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, et al. (2008) Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis and rheumatism 58: 26-35.
2. Dillon CF, Rasch EK, Gu Q, Hirsch R (2006) Prevalence of knee osteoarthritis in the United States: arthritis data from the Third National Health and Nutrition Examination Survey 1991-94. The Journal of rheumatology 33: 2271-2279. (Pubitemid 44749788)
3. Quintana JM, Arostegui I, Escobar A, Azkarate J, Goenaga JI, et al. (2008) Prevalence of knee and hip osteoarthritis and the appropriateness of joint replacement in an older population. Archives of internal medicine 168: 1576-1584.
4. American Academy of Orthopaedic Surgeons (2013) Treatment of osteoarthritis of the knee: Evidence-based guideline. 2nd ed. Rosemont, IL: American Academy of Orthopaedic Surgeons.
5. Dunlop DD, Manheim LM, Song J, Chang RW (2001) Arthritis prevalence and activity limitations in older adults. Arthritis and rheumatism 44: 212-221. (Pubitemid 32113137)
6. Guccione AA, Felson DT, Anderson JJ, Anthony JM, Zhang Y, et al. (1994) The effects of specific medical conditions on the functional limitations of elders in the Framingham Study. American journal of public health 84: 351-358. (Pubitemid 24107816)
7. Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, et al. (2010) OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis and cartilage/OARS, Osteoarthritis Research Society 18: 476-499.
8. Bar-Or D, Bar-Or R, Rael LT, Gardner DK, Slone DS, et al. (2005) Heterogeneity and oxidation status of commercial human albumin preparations in clinical use. Critical care medicine 33: 1638-1641. (Pubitemid 40980625)
9. Evans TW (2002) Review article: albumin as a drug-biological effects of albumin unrelated to oncotic pressure. Alimentary pharmacology & therapeutics 16 Suppl 5: 6-11.
10. Quinlan GJ, Martin GS, Evans TW (2005) Albumin: biochemical properties and therapeutic potential. Hepatology 41: 1211-1219. (Pubitemid 40770271)
11. Bar-Or D, Rael LT, Lau EP, Rao NK, Thomas GW, et al. (2001) An analog of the human albumin N-terminus (Asp-Ala-His-Lys) prevents formation of copper-induced reactive oxygen species. Biochemical and biophysical research communications 284: 856-862. (Pubitemid 32926747)
12. Bar-Or D, Thomas GW, Bar-Or R, Rael LT, Scarborough K, et al. (2006) Commercial human albumin preparations for clinical use are immunosuppressive in vitro. Critical care medicine 34: 1707-1712. (Pubitemid 43810052)
13. Shimonkevitz R, Thomas G, Slone DS, Craun M, Mains C, et al. (2008) A diketopiperazine fragment of human serum albumin modulates T-lymphocyte cytokine production through rap1. The Journal of trauma 64: 35-41.
14. Bar-Or D, Slone DS, Mains CW, Rael LT (2013) Dipeptidyl peptidase IV activity in commercial solutions of human serum albumin. Analytical biochemistry 441: 13-17.
15. Rael LT, Bar-Or R, Shimonkevitz R, Mains CW, Slone DS, et al. (2010) Anti-inflammatory effect of a diketopiperazine by-product of commercial albumin in TBI patients [abstract]. J Neurotrauma 27: A1-A97.
16. Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW (1988) Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. The Journal of rheumatology 15: 1833-1840. (Pubitemid 19037656)
17. Zhang W, Robertson J, Jones AC, Dieppe PA, Doherty M (2008) The placebo effect and its determinants in osteoarthritis: meta-analysis of randomised controlled trials. Annals of the rheumatic diseases 67: 1716-1723.
18. Bellamy N (2002) WOMAC Osteoarthritis Index User Guide. Version V. Brisbane, Australia.
19. Kersten P, White PJ, Tennant A (2010) The visual analogue WOMAC 3.0 scale-internal validity and responsiveness of the VAS version. BMC musculoskeletal disorders 11: 80.
20. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, et al. (2010) CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 340: c869.
21. Schulz KF, Altman DG, Moher D (2010) CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 340: c332.
22. Cole BJ, Schumacher Jr HR (2005) Injectable corticosteroids in modern practice. The Journal of the American Academy of Orthopaedic Surgeons 13: 37-46.
23. Bellamy N, Campbell J, Robinson V, Gee T, Bourne R, et al. (2006) Intraarticular corticosteroid for treatment of osteoarthritis of the knee. Cochrane database of systematic reviews: CD005328.
24. Arrich J, Piribauer F, Mad P, Schmid D, Klaushofer K, et al. (2005) Intraarticular hyaluronic acid for the treatment of osteoarthritis of the knee: systematic review and meta-analysis. CMAJ: Canadian Medical Association journal = journal de l'Association medicale canadienne 172: 1039-1043.
25. Bellamy N, Campbell J, Robinson V, Gee T, Bourne R, et al. (2006) Viscosupplementation for the treatment of osteoarthritis of the knee. Cochrane database of systematic reviews: CD005321.
26. Lo GH, LaValley M, McAlindon T, Felson DT (2003) Intra-articular hyaluronic acid in treatment of knee osteoarthritis: a meta-analysis. JAMA: the journal of the American Medical Association 290: 3115-3121.
27. Printz JO, Lee JJ, Knesek M, Urquhart AG (2013) Conflict of Interest in the Assessment of Hyaluronic Acid Injections for Osteoarthritis of the Knee: An Updated Systematic Review. The Journal of arthroplasty.
28. (2007) Three Treatments for Osteoarthritis of the Knee: Evidence Shows Lack of Benefit. Comparative Effectiveness Review Summary Guides for Clinicians. Rockville (MD).
29. Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, et al. (2005) Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Annals of the rheumatic diseases 64: 29-33. (Pubitemid 40075270)
30. Bannuru RR, Natov NS, Dasi UR, Schmid CH, McAlindon TE (2011) Therapeutic trajectory following intra-articular hyaluronic acid injection in knee osteoarthritis-meta-analysis. Osteoarthritis and cartilage/OARS, Osteoarthritis Research Society 19: 611-619.
31. Kellgren JH, Lawrence JS (1957) Radiological assessment of osteo-arthrosis. Annals of the rheumatic diseases 16: 494-502.