Clinical trial NCT03600571: Injection Site Diversity Influences HA Distribution and Clinical Results in CP and KOA
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Hyaluronan
Keywords: Viscosupplementation
Hyaluronate
Distribution
Knee osteoarthritis
Injection approach
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 64 osteoarthritic knees of cadavers were randomly assigned to two groups: the anteromedial (AM) group (n=32) and the medial midpatellar (MMP) group (n=32).

100 patients with unilateral mKOA were enrolled and randomly divided into two groups according to the injection portal of HA: the AM group (n=50) and the MMP group (n=50).
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: WOMAC (Likert version 3.1)
timeFrame: baseline before the first injection
measure: WOMAC (Likert version 3.1)
timeFrame: 1 week after the first injection
measure: WOMAC (Likert version 3.1)
timeFrame: 2 weeks after the first injection
measure: WOMAC (Likert version 3.1)
timeFrame: 3 weeks after the first injection
measure: WOMAC (Likert version 3.1)
timeFrame: 4 weeks after the first injection
measure: WOMAC (Likert version 3.1)
timeFrame: 5 weeks after the first injection
measure: WOMAC (Likert version 3.1)
timeFrame: 14 weeks after the first injection
measure: WOMAC (Likert version 3.1)
timeFrame: 24 weeks after the first injection
measure: Lequesne index
timeFrame: baseline before the first injection
measure: Lequesne index
timeFrame: 1 week after the first injection
measure: Lequesne index
timeFrame: 2 weeks after the first injection
measure: Lequesne index
timeFrame: 3 weeks after the first injection
measure: Lequesne index
timeFrame: 4 weeks after the first injection
measure: Lequesne index
timeFrame: 5 weeks after the first injection
measure: Lequesne index
timeFrame: 14 weeks after the first injection
measure: Lequesne index
timeFrame: 24 weeks after the first injection
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
References: