NCT03600571

Injection Site Diversity Influences HA Distribution and Clinical Results in CP and KOA

Injection Site Diversity Influences Sodium Hyaluronate Distribution and Its Clinical Results in Management of Chondromalacia Patellae and Knee Osteoarthritis: A Preliminary, Multi-central, Randomize-controlled Serial Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee
• Hyaluronan

Interventions

Type	Name	Description
PROCEDURE	medial midpatellar (MMP) portal	injection medial under horizontal patella midline was administrated with the lower limb extension
PROCEDURE	anteromedial (AM) portal	injection medial from patella tendon towards intercondylar notch was performed with the target knee 90° flexion

Timeline

• Start date: 2014-08-30
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2018-07-26
• Last updated: 2018-07-26

Locations

1 site across 1 country: China