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

Nanfang Hospital, Southern Medical University

Status and phase: Completed; Phase 4

Conditions: Hyaluronan; Osteoarthritis, Knee

Treatments: Procedure: medial midpatellar (MMP) portal; Procedure: anteromedial (AM) portal

Study type: Interventional

Funder types: Other

Identifiers

NCT03600571

NFEC-2014-074

Details and patient eligibility

About

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.

Enrollment: 164 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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164 participants in 4 patient groups

AM groups in cadavers study

Experimental group

Description:

32 osteoarthritic knees of cadavers were randomly assigned to the AM group (injection medial from patella tendon towards intercondylar notch was performed with the target knee 90° flexion). 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.

Treatment:

Procedure: anteromedial (AM) portal

MMP groups in cadavers study

Experimental group

Description:

32 osteoarthritic knees of cadavers were randomly assigned to the MMP group (injection medial under horizontal patella midline was administrated with the lower limb extension). 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.

Treatment:

Procedure: medial midpatellar (MMP) portal

AM groups in random controlled trial

Experimental group

Description:

50 patients with unilateral mKOA were enrolled and randomly into the AM group (injection medial from patella tendon towards intercondylar notch was performed with the target knee 90° flexion).The clinical outcomes of 5-weekly injections of HA were evaluated by WOMAC and Lequesne index. The follow-up times were at weeks 1, 2, 3, 4, 5, 14, and 24 after the injections.

Treatment:

Procedure: anteromedial (AM) portal

MMP groups in random controlled trial

Experimental group

Description:

50 patients with unilateral mKOA were enrolled and randomly into the MMP group (injection medial under horizontal patella midline was administrated with the lower limb extension).The clinical outcomes of 5-weekly injections of HA were evaluated by WOMAC and Lequesne index. The follow-up times were at weeks 1, 2, 3, 4, 5, 14, and 24 after the injections.

Treatment:

Procedure: medial midpatellar (MMP) portal