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NCT03600571
Injection Site Diversity Influences HA Distribution and Clinical Results in CP and KOA
Phase 4 trial testing medial midpatellar (MMP) portal in Osteoarthritis, Knee in 164 participants. Completed in 1 May 2018.
1 May 2018
Quick facts
| Lead sponsor | Nanfang Hospital, Southern Medical University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 164 |
| Start date | 30 August 2014 |
| Primary completion | 1 May 2018 |
| Estimated completion | 1 May 2018 |
| Sites | 1 location across China |
Drugs / interventions tested
- medial midpatellar (MMP) portal
- anteromedial (AM) portal
Conditions studied
- Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →
- Hyaluronan — all drugs for Hyaluronan →
Sponsor
Nanfang Hospital, Southern Medical University
Who can join
18 and older, any sex, with Osteoarthritis, Knee or Hyaluronan. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03600571
- Europe PMC full search
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Other Nanfang Hospital, Southern Medical University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03600571 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nanfang Hospital, Southern Medical University
- Last refreshed: 26 July 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03600571.
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