Noltrex®Vet Clinical Study Design & Results
Principal Investigator: Dr. Scott McClure, DVM, PhD, Dipl. ACVS
“A Preliminary Field Trial Evaluating the Efficacy of 4% Polyacrylamide Hydrogel in Horses with Osteoarthritis“
Mcclure, S. R., & Wang, C. (2017). A Preliminary Field Trial Evaluating the Efficacy of 4% Polyacrylamide Hydrogel in Horses With Osteoarthritis. Journal of Equine Veterinary Science, 54, 98-102. doi:10.1016/j.jevs.2017.02.0192
This is an IACUC approved, non-blinded, single arm, multicenter, prospective field trial in horses with naturally occurring osteoarthritis in a single joint confirmed by intra-articular anesthesia and radiographic evidence.
Distal and proximal interphalangeal, metacarpophalangeal, radialcarpal and intercarpal joints were included based on relatively similar size and motion of the joints.
Success criteria: at least 1-grade decrease in lameness or a combined reduction of at least 3-point decrease among scores for pain, range of motion and joint swelling using the respective AAEP scales for each from the time of treatment with Noltrex®Vet to 45 days after treatment.
35 horses entered the study, all of which were observed throughout the 45-day study period and 32 horses of which were available for the 90-day follow-up for adverse events evaluation
28 of 35 horses met the study criteria and were included in the analyses.
23 of 28 (82%) of the horses met the study success criteria at day 45 (primary endpoint). There was a significant (P < 0.001) decrease in mean lameness score from 2.34 to 0.87.
21 of 28 (75%) of the horses met study criteria for improvement at day 90 along with a further improvement of lameness score with one injection.
There were no adverse events related to the product observed in any horses.
Conclusion: Intra-articular polyacrylamide provided a prolonged decrease in lameness in horses with naturally occurring osteoarthritis.