Intra-articular 2.5% polyacrylamide hydrogel for the treatment of knee osteoarthritis: an observational proof-of-concept cohort study

TY - JOUR

T1 - Intra-articular 2.5% polyacrylamide hydrogel for the treatment of knee osteoarthritis

T2 - an observational proof-of-concept cohort study

AU - Henriksen, Marius

AU - Overgaard, Anders

AU - Hartkopp, Andreas

AU - Bliddal, Henning

PY - 2018/11/1

Y1 - 2018/11/1

N2 - OBJECTIVES: There is a drought of effective treatments of knee osteoarthritis (OA) and new therapies are needed. The present study has been conducted to establish an initial estimate of effectiveness of intra-articular (IA) injection of a proprietary 2.5% cross-linked polyacrylamide hydrogel (PAAG) for the treatment of knee OA symptoms and signs. METHODS: Patients with knee OA were invited into a prospective open-label cohort study. The patients received up to two IA injections of 3 ml of PAAG 1 month apart. The WOMAC questionnaire was used to estimate effectiveness, and was collected at baseline and after 4, 7 and 13 months. Primary outcome was change from baseline for the WOMAC pain subscale after 4 months (Normalised to 0-100 points; 100 worst). Data was analysed using a mixed-effect model without imputation of missing data. RESULTS: 84 patients (48 females) received IA PAAG. Of these WOMAC data were available from 62 after 4 months, 59 after 7 months, and 56 after 13 months. There were statistically and clinically significant reductions in WOMAC pain after 4 months (mean change -14.6 points [95% CI: -18.9 to -10.2]; p<.0001). Similar results were found in WOMAC stiffness, physical function, and WOMAC total. The improvement was sustained throughout the observation period. CONCLUSIONS: These results suggest beneficial effects of IA injection of PAAG on knee OA symptoms, even in the long term (1 year). This initial estimation of effectiveness is promising but needs to be confirmed in a randomised study with adequate measures taken to reduce risk of bias.

AB - OBJECTIVES: There is a drought of effective treatments of knee osteoarthritis (OA) and new therapies are needed. The present study has been conducted to establish an initial estimate of effectiveness of intra-articular (IA) injection of a proprietary 2.5% cross-linked polyacrylamide hydrogel (PAAG) for the treatment of knee OA symptoms and signs. METHODS: Patients with knee OA were invited into a prospective open-label cohort study. The patients received up to two IA injections of 3 ml of PAAG 1 month apart. The WOMAC questionnaire was used to estimate effectiveness, and was collected at baseline and after 4, 7 and 13 months. Primary outcome was change from baseline for the WOMAC pain subscale after 4 months (Normalised to 0-100 points; 100 worst). Data was analysed using a mixed-effect model without imputation of missing data. RESULTS: 84 patients (48 females) received IA PAAG. Of these WOMAC data were available from 62 after 4 months, 59 after 7 months, and 56 after 13 months. There were statistically and clinically significant reductions in WOMAC pain after 4 months (mean change -14.6 points [95% CI: -18.9 to -10.2]; p<.0001). Similar results were found in WOMAC stiffness, physical function, and WOMAC total. The improvement was sustained throughout the observation period. CONCLUSIONS: These results suggest beneficial effects of IA injection of PAAG on knee OA symptoms, even in the long term (1 year). This initial estimation of effectiveness is promising but needs to be confirmed in a randomised study with adequate measures taken to reduce risk of bias.

KW - Acrylic Resins/administration & dosage

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Female

KW - Humans

KW - Injections, Intra-Articular

KW - Knee Joint/physiopathology

KW - Male

KW - Middle Aged

KW - Osteoarthritis, Knee/diagnosis

KW - Proof of Concept Study

KW - Prospective Studies

KW - Recovery of Function

KW - Time Factors

KW - Treatment Outcome

M3 - Journal article

C2 - 30148430

SN - 0392-856X

VL - 36

SP - 1082

EP - 1085

JO - Clinical and Experimental Rheumatology

JF - Clinical and Experimental Rheumatology

IS - 6

ER -