Feasibility and predictive value of proposed early endpoints for randomized controlled trials in knee osteoarthritis
Authors' conclusion
Based on feasibility (sample size) and clinical relevance (association with subsequent TKR), we propose that the esKOA, CKOASO, and FNIH endpoints be prioritized for further consideration.
Study context
- Population
- Knees from the Osteoarthritis Initiative meeting typical randomized controlled trial (RCT) inclusion criteria, including pain and radiographic osteoarthritis (OA)knees, one per participant
- Participants
- 1,350 knees
- Exposure
- Proposed early endpoints for knee OA RCTs compared for feasibility and association with subsequent total knee replacement (TKR)
- Outcome
- Cumulative incidence of each endpoint and sample size required for an RCT to detect HR 0.67 with 80% power
- Follow-up
- 4 years
Methodological detailsOsteoarthritis Initiative data, sample size simulation for RCT (HR 0.67, 80% power)
- Osteoarthritis Initiative data
- Sample size simulation for RCT (HR 0.67, 80% power)
Main finding
As reported in the abstract
| Group | Value | Sample size per arm |
|---|---|---|
| TKR | 4.3% | 3028 |
| FNIH | 13.8% | |
| End-stage knee OA (esKOA) | 34.4% | |
| Composite Knee Osteoarthritis Symptom Outcome (CKOASO) | 63.6% | 229 |
Value
TKR4.3%
FNIH13.8%
End-stage knee OA (esKOA)34.4%
Composite Knee Osteoarthritis Symptom Outcome (CKOASO)63.6%
Sample size per arm
TKR3028
FNIH— not stated in the abstract
End-stage knee OA (esKOA)— not stated in the abstract
Composite Knee Osteoarthritis Symptom Outcome (CKOASO)229
Observational data: associations, not effects.
Further findings
| Outcome | esKOA | CKOASO | FNIH |
|---|---|---|---|
| RR of subsequent TKR after reaching endpoint · subsequent 5 years | |||
| RR | 5.7 | 4.3 | 2.6 |
Original publication
Feasibility and predictive value of proposed early endpoints for randomized controlled trials in knee osteoarthritis. Osteoarthritis Cartilage. Published 20 February 2026. doi:10.
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