Meaningful Changes in Physical Function and Pain in Patients with K-L Grade 3 Knee Osteoarthritis
Author(s)
Xiaodan Tang, PhD1, Jin Shei Lai, PhD2, Kang-Il Kim, MD PhD3, Sung Keun Kang, DVM PhD4, John D. Peipert, PhD5;
1Northwestern University, Assistant Professor, Chicago, IL, USA, 2Northwestern University, Medical Social Sciences, Chicago, IL, USA, 3Kyung Hee University, Seoul, Korea, Republic of, 4Biostar Stem Cell Research Institute, Seoul, Korea, Republic of, 5University of Birmingham, Edgbaston Birmingham, United Kingdom
1Northwestern University, Assistant Professor, Chicago, IL, USA, 2Northwestern University, Medical Social Sciences, Chicago, IL, USA, 3Kyung Hee University, Seoul, Korea, Republic of, 4Biostar Stem Cell Research Institute, Seoul, Korea, Republic of, 5University of Birmingham, Edgbaston Birmingham, United Kingdom
OBJECTIVES: This study aims to establish meaningful within-person change (MWPC) thresholds for the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®), its Physical Function (PF) subscale, and the Visual Analog Scale (VAS) for Pain, in patients with Kellgren-Lawrence (K-L) grade 3 knee osteoarthritis (OA). A secondary objective is to evaluate the effectiveness of a single injection of autologous culture-expanded adipose tissue-derived mesenchymal stem cells (ADMSCs) using these thresholds.
METHODS: The study included 252 patients with knee OA enrolled in a clinical trial. Anchor-based predictive modeling approach, using Knee Injury and Osteoarthritis Outcome Score (KOOS)-12, the 36-Item Short Form Survey (SF-36), and the International Knee Documentation Committee (IKDC) scores with literature-based cut-offs, was used to determine MWPC thresholds for WOMAC and VAS Pain. MWPC thresholds were derived from both the ADMSCs injection and Control (autoserum) groups at 3- and 6-month follow-ups. Treatment effectiveness was assessed by comparing the MWPC range with between-group differences and within-person changes.
RESULTS: MWPC thresholds were identified as follows: 5-17 points for WOMAC Total, 4-12 points for WOMAC PF, and 8-14 points for VAS Pain (all on 0-100 scales). For treatment effectiveness, most patients in the ADMSCs group reported meaningful improvements in physical function and pain at 6-month. Furthermore, a higher proportion of patients in the ADMSCs group achieved meaningful improvement compared to the Control (autoserum) group at both 3 and 6 months.
CONCLUSIONS: This study established MWPC thresholds for WOMAC and VAS Pain in patients with knee OA and demonstrates their utility in evaluating meaningful treatment benefits. These findings highlight the potential of ADMSCs treatment provides clinically relevant improvements in physical function and pain.
METHODS: The study included 252 patients with knee OA enrolled in a clinical trial. Anchor-based predictive modeling approach, using Knee Injury and Osteoarthritis Outcome Score (KOOS)-12, the 36-Item Short Form Survey (SF-36), and the International Knee Documentation Committee (IKDC) scores with literature-based cut-offs, was used to determine MWPC thresholds for WOMAC and VAS Pain. MWPC thresholds were derived from both the ADMSCs injection and Control (autoserum) groups at 3- and 6-month follow-ups. Treatment effectiveness was assessed by comparing the MWPC range with between-group differences and within-person changes.
RESULTS: MWPC thresholds were identified as follows: 5-17 points for WOMAC Total, 4-12 points for WOMAC PF, and 8-14 points for VAS Pain (all on 0-100 scales). For treatment effectiveness, most patients in the ADMSCs group reported meaningful improvements in physical function and pain at 6-month. Furthermore, a higher proportion of patients in the ADMSCs group achieved meaningful improvement compared to the Control (autoserum) group at both 3 and 6 months.
CONCLUSIONS: This study established MWPC thresholds for WOMAC and VAS Pain in patients with knee OA and demonstrates their utility in evaluating meaningful treatment benefits. These findings highlight the potential of ADMSCs treatment provides clinically relevant improvements in physical function and pain.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
CO124
Topic
Clinical Outcomes
Disease
SDC: Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)