Injection Site Diversity Influences HA Distribution and Clinical Results in CP and KOA (NCT03600571) | Clinical Trial Compass
CompletedPhase 4
Injection Site Diversity Influences HA Distribution and Clinical Results in CP and KOA
China164 participantsStarted 2014-08-30
Plain-language summary
In order to investigate the difference of intra-articular hyaluronate's distribution and compare the clinical outcomes of viscosupplementation for mild-to-moderate knee osteoarthritis (mKOA) between the anteromedial (AM) and medial midpatellar (MMP) approach groups. This study included two parts, cadaver study (n=64) and random controlled trial (n=100). Hyaluronic acid (HA) traced by methylene blue was injected into the knee, and the intra-articular distribution of HA was assessed using a five-point scale in the cadaver study. The clinical outcomes of 5-weekly injections of HA were evaluated by WOMAC and Lequesne index and the follow-up times were at weeks 1, 2, 3, 4, 5, 14, and 24 after the injections in the random controlled trial.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Symptomatic unilateral mild-to-moderate knee osteoarthritis (mKOA) that were defined by the American College of Rheumatology criteria
* Kellgren-Lawrence grade 2 or 3
* Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index (Likert version 3.1) pain subscale reached 10 or greater
Exclusion Criteria:
* Pregnancy, acute fracture, rheumatoid arthritis, gouty arthritis, traumatic arthritis, inflammatory arthritis
* Oral Celebrex within 2 weeks, HA and lidocaine allergy, intra-articular injection of HA or corticosteroid to the target knee within the past 6 months
* Surgery in the target knee within the past 6 months, OA of the target knee with K-L grade 4
* Active liver and renal disease, cardiovascular and cerebrovascular disease.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
WOMAC (Likert version 3.1)
Timeframe: baseline before the first injection
2
WOMAC (Likert version 3.1)
Timeframe: 1 week after the first injection
3
WOMAC (Likert version 3.1)
Timeframe: 2 weeks after the first injection
4
WOMAC (Likert version 3.1)
Timeframe: 3 weeks after the first injection
5
WOMAC (Likert version 3.1)
Timeframe: 4 weeks after the first injection
6
WOMAC (Likert version 3.1)
Timeframe: 5 weeks after the first injection
7
WOMAC (Likert version 3.1)
Timeframe: 14 weeks after the first injection
8
WOMAC (Likert version 3.1)
Trial details
NCT IDNCT03600571
SponsorNanfang Hospital, Southern Medical University