Injection Site Diversity Influences HA Distribution and Clinical Results in CP and KOA
NCT ID: NCT03600571
Last Updated: 2018-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
164 participants
INTERVENTIONAL
2014-08-30
2018-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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).
TREATMENT
DOUBLE
Study Groups
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AM groups in cadavers study
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.
anteromedial (AM) portal
injection medial from patella tendon towards intercondylar notch was performed with the target knee 90° flexion
MMP groups in cadavers study
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.
medial midpatellar (MMP) portal
injection medial under horizontal patella midline was administrated with the lower limb extension
AM groups in random controlled trial
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.
anteromedial (AM) portal
injection medial from patella tendon towards intercondylar notch was performed with the target knee 90° flexion
MMP groups in random controlled trial
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.
medial midpatellar (MMP) portal
injection medial under horizontal patella midline was administrated with the lower limb extension
Interventions
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medial midpatellar (MMP) portal
injection medial under horizontal patella midline was administrated with the lower limb extension
anteromedial (AM) portal
injection medial from patella tendon towards intercondylar notch was performed with the target knee 90° flexion
Eligibility Criteria
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Inclusion 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
* 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.
18 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Locations
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Nanfang Hospital
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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NFEC-2014-074
Identifier Type: -
Identifier Source: org_study_id
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