A randomized double-blind clinical trial on the treatment of knee osteoarthritis: the efficacy of polynucleotides compared to standard hyaluronian viscosupplementation.
BACKGROUND
This randomized, double-blind, parallel-group clinical trial aims to assess the equivalence of intra-articular polynucleotides compared to standard hyaluronic acid (HA) viscosupplementation in the treatment of knee osteoarthritis (OA).


METHODS
75 patients affected by knee OA were assessed for eligibility and 72 were enrolled and randomized to receive either intra-articular polynucleotides (Condrotide-36 patients) or hyaluronic acid (Hyalubrix-36 patients) at the Orthopedic Institute "Gaetano Pini" (Milan). All patients underwent three intra-articular injections of Condrotide or Hyalubrix with an interval of 1week. Participants, care givers, and investigators responsible for outcome assessment were all blinded to group assignment. Primary outcome measurements (KOOS and pain level (1) at rest, (2) at weight-bearing and (3) during physical activity) were evaluated at baseline (T0) and after one (T1), two (T2), six (T6), ten (T10), and 26 (T26)weeks. Secondary measurements included the determination of COMP serum levels at T0, T6 and T26.


RESULTS
The reduction of pain and the increase of KOOS values from baseline were statistically significant for both treatments; nevertheless, for parameter KOOS "symptoms" the treatment with Condrotide showed significant results already after twoweeks (at T2 p=0.003) while the results obtained with Hyalubrix became significant only after 18 weeks (at T18 p=0.01). No significant adverse events were reported.


CONCLUSIONS
Condrotide is as effective as Hyalubrix in reducing knee OA symptoms but showed an earlier response on pain reduction and can therefore be considered a valid alternative to the use of HA in the treatment of OA, avoiding the adverse events of NSAIDs and of intra-articular corticosteroids.
Scuola di Specializzazione in Ortopedia e Traumatologia -Università degli, Studi di Milano, Italy. Electronic address: laura.giarratana@unimi.it.
Laura S
LS
Giarratana
Direttore Dipartimento Ortopedia e Traumatologia, Istituto Ortopedico Gaetano Pini, Milano, Italy.
Bruno M
BM
Marelli
Direttore U.O.C. Patologia Clinica, Istituto Ortopedico Gaetano Pini, Milano, Italy.
Calogero
C
Crapanzano
Scuola di Specializzazione in Ortopedia e Traumatologia -Università degli, Studi di Milano, Italy.
Silvia E
SE
De Martinis
Specialista in Ortopedia e Traumatologia, Istituto Ortopedico Gaetano Pini, Milano, Italy.
Luca
L
Gala
Dirigente Medico, Istituto Ortopedico Gaetano Pini, Milano, Italy.
Marcello
M
Ferraro
Facoltà di Medicina e Chirurgia, Università degli Studi di Milano, Italy.
Niccolò
N
Marelli
Dipartimento di Scienze Biomediche, Chirurgiche ed Odontoiatriche, Università degli Studi di Milano, Italy.
Walter
W
Albisetti
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018771:Arthralgia / Q000188:drug therapy*; D064236:Cartilage Oligomeric Matrix Protein / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000627:therapeutic use*; D007270:Injections, Intra-Articular; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D011119:Polynucleotides / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D055675:Viscosupplements / Q000627:therapeutic use*; D064232:Visual Analog Scale
D064236:Cartilage Oligomeric Matrix Protein; C000594595:Condrotide; D011119:Polynucleotides; D055675:Viscosupplements; D006820:Hyaluronic Acid
COMP; Hyaluronic acid; Osteoarthritis; Pain relief; Polynucleotides