Efficacy of the combination therapy of platelet-rich plasma and hyaluronic acid on improving knee pain and dysfunction in patients with moderate-to-severe KOA: a protocol for a randomised controlled trial
Bibliographic record
Abstract
INTRODUCTION: 54% of patients with moderate-to-severe knee osteoarthritis (KOA) still reported persistent pain and functional loss after conservative treatment according to guidelines. As an emerging treatment, platelet-rich plasma (PRP) has been proven to significantly relieve pain and improve activity function in patients with mild-to-moderate KOA, either used alone or in combination with hyaluronic acid (HA). However, it is still unclear of its efficacy in moderate-to-severe KOA. This study aims to evaluate the clinical efficacy of PRP and the combination therapy of PRP and HA in patients with moderate-to-severe KOA and to explore the potential synergistic effect of PRP and HA. METHODS AND ANALYSIS: This triple-blind randomised controlled trial will involve a total of 162 participants with moderate-to-severe KOA from two study centres. Participants will be allocated randomly into three groups: the HA group, the PRP group and the combination (PRP+HA) group and, respectively, receive HA (2.5 mL)+saline (3 mL)/PRP (3 mL)+saline (2.5 mL)/PRP (3 mL)+HA (2.5 mL) intra-articular injection each week for 4 consecutive weeks. All of the injections will be performed under the guidance of ultrasound. The primary outcome is the change of Western Ontario and McMaster Universities Osteoarthritis Index from baseline to 6 months, and secondary outcomes include the change of ultrasound images (suprapatellar bursa effusion and synovitis), Timed Up and Go test and 12-Item Short-Form Health Survey. All outcomes will be evaluated at baseline and 1-month, 3-month and 6-month follow-ups. Data will be analysed on intention-to-treat principles and a per-protocol basis. ETHICS AND DISSEMINATION: This protocol was approved by the Medical Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University (reference number (2021)-02-231-02). The study results will be submitted to a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ChiCTR2100050974.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.032 | 0.029 |
| Meta-epidemiology (narrow) | 0.005 | 0.002 |
| Meta-epidemiology (broad) | 0.012 | 0.008 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.002 | 0.004 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.010 | 0.005 |
| Insufficient payload (model declined to judge) | 0.033 | 0.006 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".