Clinical Pathway Management for Platelet-Rich Plasma Therapy in Kellgren-Lawrence Grade I and II Knee Osteoarthritis: A Prospective, Multicentre, Double-Blind Randomised Controlled Trial
The American Journal of Sports Medicine · 26 Oct 2026
† Impact is the editorial-priority score. All scores are out of 100. Clinical is a stored clinical-importance score from the earlier method; it has not been recalculated.
Why it matters
How PRP is delivered (preparation, image guidance, rehab) may matter as much as whether it is given at all, which helps explain the conflicting PRP literature in knee osteoarthritis.
The evidence
This three-hospital randomised trial in China enrolled 240 adults with early (Kellgren-Lawrence grade I-II) knee osteoarthritis. All patients received PRP injections; half got them through a standardised pathway (lab-checked leukocyte-poor PRP, ultrasound-guided injections, staged rehab, and scheduled follow-up), and half got whatever their physician usually did. At 12 months the pathway group had better pain and function scores on all three primary measures; WOMAC showed a standardised effect size of -0.83. The pathway group also had fewer patients with an adverse event (17/115 vs 36/113), but there was no difference in cartilage structure on imaging.
WOMAC total score at 12 months: Smd -0.83 (95% CI unavailable; WOMAC). Interpret in the study's stated comparison; this alone does not establish a treatment's causal effect.
Why this rigour score?
Multicentre RCTDesign starting point: 63.4
Raised the score
- Blinded outcome assessment+6.8
- Adequately powered+6
Lowered the score
- Control arm not optimally delivered−4.3
Methods at a glance
Recorded assessment- Outcome assessors blindedMet
- Allocation concealedMet
- Random sequence generatedMet
- Intention-to-treat analysisMet
- Adequate statistical powerMet
- Prospective registrationMet
Not reported does not mean not done. Checks have different weights; this is not a count of boxes ticked.
See the full score breakdown
- Study design starting point
- 63.4
- Concealed allocation
- +5.1
- Random sequence generation
- +2.5
- Control arm not optimally delivered
- −4.3
- Blinded outcome assessment
- +6.8
- Intention-to-treat analysis
- +3.4
- 0% loss to follow-up
- +1.7
- Adequately powered
- +6
- Prospectively registered
- +5.1
- Final rigour score rounded
- 90 / 100
Study design sets the starting point and a ceiling of 100. Recorded methods then adjust the score. Points are shown to one decimal place; the final score uses unrounded values.
Checklist from the stored appraisal. “Not met” describes the recorded criterion; it does not always produce a deduction. This overview supports reading the full study.
For journal club
1.Since this trial had no placebo arm and placebo-controlled work such as RESTORE found no PRP benefit, how would you counsel a patient with grade II knee osteoarthritis who asks whether PRP is worth paying for?
2.If the structured rehabilitation and follow-up are a major driver of the benefit, should clinicians prioritise a supervised exercise programme before or instead of offering PRP injections in early knee osteoarthritis?
Original publication title
Clinical Pathway Management for Platelet-Rich Plasma Therapy in Kellgren-Lawrence Grade I and II Knee Osteoarthritis: A Prospective, Multicenter, Double-Blind Randomized Controlled Trial