A Phase 2 interventional study of a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRP in Knee OA, sponsored by Kaohsiung Veterans General Hospital.. Completed at 2 sites in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-03-19.
Sponsored by Kaohsiung Veterans General Hospital. · Phase 2, Interventional, and Treatment
Intraarticular hyaluronan or platelet-rich plasma (PRP) is each effective in the treatment for knee osteoarthritis (OA). The efficacy of combined hyaluronan with PRP for knee OA remained unclear. This study aimed to investigate the efficacy of a single intraarticular hyaluronan (HYAJOINT Plus) combined with a single PRP versus a single intraarticular PRP in patients with knee OA.
Intraarticular HA or PRP has been used for knee OA for years. Combined HA and PRP has not been widely used for OA because of lack of clinical evidence. Based on in vitro and animal studies, combining HA and PRP may benefit from their dissimilar biological mechanisms for tissue repair and have potentials to synergistically promote cartilage regeneration, inhibit OA inflammation, modulate the disease process, and improve joint homeostasis in OA. Combination of HA and PRP has much potential for the treatment of OA, but the clinical evidence of this combination remains unclear. The purpose of this study was to investigate the efficacy and safety of combined a single crosslinked HA (HYAJOINT Plus) with a single PRP versus a single PRP alone in patients with knee OA.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's enrollment of 85 is above the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Kaohsiung Veterans General Hospital. is the lead sponsor of 106 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
patients received a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRP
Combination Product: a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRP
patients received a single injection of 3 ml PRP
Combination Product: a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRP
All the injections were done by the same experienced physician using aseptic procedures.
Also known as: the one-injection group received a single injection of 3 ml PRP
VAS pain score change from baseline
. The patient rated the average severity of knee pain on knee movement over the previous week on a 0-100 mm VAS (0=no pain to 100=worst possible pain)
Time frame: 1,3 and 6 months
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert Scale)
a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Total score is 96 and higher scores indicate worse outcomes.
Time frame: 1,3 and 6 months
Lequesne index
used to assess severity of knee symptoms during the last week. It includes the measurement of pain, walking distance, and activities of daily living. Maximal score is 24 and higher scores represent worse function.
Time frame: 1,3 and 6 months
Single-leg stance test (SLS)
done by raising one foot up without touching it to the supported lower extremity with target knee and maintain balance for as long as possible. Each participant performed 3 trials, and the best result of the 3 trials was recorded.
Time frame: 1,3 and 6 months
satisfaction
Patients were asked to rate their treatment satisfaction compared to the preinjection condition, using a 100 mm VAS (0= completely dissatisfied, 100=completely satisfied).
Time frame: 1,3 and 6 months
consumption of analgesics
Acetaminophen (500mg; maximum daily dose, 4 g) was the only rescue medication allowed for knee pain. Acetaminophen was not permitted during the 24-hour period prior to each study visit. Use of rescue medication during the study period was recorded in a patient diary.
Time frame: 1,3 and 6 months
Plan to share: No
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Kaohsiung Veterans General Hospital. →