Trial · NCT07901153
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in WOMAC Total Score From Baseline to 12 Months | Baseline and 12 months after the intervention | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), validated Brazilian Portuguese version. The WOMAC has 24 items (pain, 5 items; stiffness, 2 items; physical function, 17 items), each scored from 0 (none) to 4 (extreme) on a Likert scale. The total score ranges from 0 to 96 points, and higher scores indicate worse pain, stiffness and physical function (worse outcome). The outcome is the change from baseline to 12 months; a greater reduction indicates greater improvement. Primary comparison: PRP combined with hyaluronic acid versus PRP alone. |
| Secondary | WOMAC Total and Subscale Scores (Pain, Stiffness and Physical Function) | Baseline, 3, 6, 12 and 24 months after the intervention | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), validated Brazilian Portuguese version, compared among the three groups. Total score ranges from 0 to 96; subscales range from 0 to 20 (pain), 0 to 8 (stiffness) and 0 to 68 (physical function). For the total score and all subscales, higher scores indicate worse symptoms and function (worse outcome). |
| Secondary | Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline, 3, 6, 12 and 24 months after the intervention | Knee Injury and Osteoarthritis Outcome Score (KOOS), validated Brazilian Portuguese version, five subscales scored separately: pain, other symptoms, function in activities of daily living, function in sport and recreation, and knee-related quality of life. Each subscale ranges from 0 (extreme knee problems) to 100 (no knee problems); higher scores indicate better outcomes. |
| Secondary | Lysholm Knee Scoring Scale | Baseline, 3, 6, 12 and 24 months after the intervention | Lysholm score (0 to 100; higher scores indicate better knee function). |
| Secondary | Tegner Activity Level | Baseline, 3, 6, 12 and 24 months after the intervention | Tegner activity scale (0 to 10; higher levels indicate higher physical and sports activity). |
| Secondary | International Knee Documentation Committee (IKDC) Subjective Knee Form | Baseline, 3, 6, 12 and 24 months after the intervention | IKDC subjective score (0 to 100; higher scores indicate better knee function and fewer symptoms). |
| Secondary | Knee Pain Intensity by Visual Analog Scale (VAS) | Baseline, 3, 6, 12 and 24 months after the intervention | Average knee pain in the previous week on a 0 to 10 visual analog scale (0 = no pain; 10 = worst imaginable pain). |
| Secondary | Patient Global Impression of Improvement (PGI-I) | 3, 6, 12 and 24 months after the intervention | Participant-rated global impression of change on a 7-point scale (1 = very much better; 7 = very much worse). |
| Secondary | Satisfaction With Treatment | 3, 6, 12 and 24 months after the intervention | Participant satisfaction with the treatment received on a 5-point Likert scale (1 = very dissatisfied; 5 = very satisfied). |
| Secondary | Proportion of OMERACT-OARSI Responders | 3, 6, 12 and 24 months after the intervention | Responders defined as improvement of at least 50% and 20 points (0 to 100 scale) in pain or function, or improvement of at least 20% and 10 points in at least two of pain, function and patient global assessment. |
| Secondary | Use of Rescue Medication | Up to 24 months after the intervention | Use of rescue medication in each follow-up period (yes or no), drug, dose and frequency, expressed as number of days of use and cumulative dose of acetaminophen and other analgesics or anti-inflammatory drugs. |
| Secondary | Cointerventions, New Injections and Knee Surgery | Up to 24 months after the intervention | Number of participants with cointerventions, new intra-articular injections, surgical referral, surgery on the target knee or knee arthroplasty. |
| Secondary | Incidence of Adverse Events | Up to 24 months after the intervention | Number and type of adverse events, related or not to the intervention (for example, post-injection pain, effusion, stiffness, bruising, vasovagal reaction and septic arthritis), graded by severity and relationship to the procedure. |
| Other | Association Between PRP Characteristics and Clinical Response | Baseline and 12 months after the intervention | Association between change in WOMAC total score and PRP characteristics: platelet concentration, total platelet dose, injected volume, leukocytes, red blood cells, concentration factor and platelet recovery. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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