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

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03600571
• Other study ID #: NFEC-2014-074
• Status: Completed
• Phase: Phase 4
• Start date: August 30, 2014
• Est. completion date: May 1, 2018

Study information

• Verified date: May 2018
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyaluronan
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
China	Nanfang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC (Likert version 3.1)	WOMAC included three subscales: pain, stiffness and function, and each subscale was graded using a 5-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme). Pain index score ranges from 0 to 20, whereas the stiffness score ranges from 0 to 8 and the function score ranges from 0 to 68. The reliability of the three subscales of the WOMAC was 0.82, 0.68 and 0.74, respectively.	baseline before the first injection
Primary	WOMAC (Likert version 3.1)	WOMAC included three subscales: pain, stiffness and function, and each subscale was graded using a 5-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme). Pain index score ranges from 0 to 20, whereas the stiffness score ranges from 0 to 8 and the function score ranges from 0 to 68. The reliability of the three subscales of the WOMAC was 0.82, 0.68 and 0.74, respectively.	1 week after the first injection
Primary	WOMAC (Likert version 3.1)	WOMAC included three subscales: pain, stiffness and function, and each subscale was graded using a 5-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme). Pain index score ranges from 0 to 20, whereas the stiffness score ranges from 0 to 8 and the function score ranges from 0 to 68. The reliability of the three subscales of the WOMAC was 0.82, 0.68 and 0.74, respectively.	2 weeks after the first injection
Primary	WOMAC (Likert version 3.1)	WOMAC included three subscales: pain, stiffness and function, and each subscale was graded using a 5-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme). Pain index score ranges from 0 to 20, whereas the stiffness score ranges from 0 to 8 and the function score ranges from 0 to 68. The reliability of the three subscales of the WOMAC was 0.82, 0.68 and 0.74, respectively.	3 weeks after the first injection
Primary	WOMAC (Likert version 3.1)	WOMAC included three subscales: pain, stiffness and function, and each subscale was graded using a 5-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme). Pain index score ranges from 0 to 20, whereas the stiffness score ranges from 0 to 8 and the function score ranges from 0 to 68. The reliability of the three subscales of the WOMAC was 0.82, 0.68 and 0.74, respectively.	4 weeks after the first injection
Primary	WOMAC (Likert version 3.1)	WOMAC included three subscales: pain, stiffness and function, and each subscale was graded using a 5-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme). Pain index score ranges from 0 to 20, whereas the stiffness score ranges from 0 to 8 and the function score ranges from 0 to 68. The reliability of the three subscales of the WOMAC was 0.82, 0.68 and 0.74, respectively.	5 weeks after the first injection
Primary	WOMAC (Likert version 3.1)	WOMAC included three subscales: pain, stiffness and function, and each subscale was graded using a 5-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme). Pain index score ranges from 0 to 20, whereas the stiffness score ranges from 0 to 8 and the function score ranges from 0 to 68. The reliability of the three subscales of the WOMAC was 0.82, 0.68 and 0.74, respectively.	14 weeks after the first injection
Primary	WOMAC (Likert version 3.1)	WOMAC included three subscales: pain, stiffness and function, and each subscale was graded using a 5-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme). Pain index score ranges from 0 to 20, whereas the stiffness score ranges from 0 to 8 and the function score ranges from 0 to 68. The reliability of the three subscales of the WOMAC was 0.82, 0.68 and 0.74, respectively.	24 weeks after the first injection
Primary	Lequesne index	The Lequesne index questionnaire included 10 questions about pain, stiffness and function. The score ranges from 0 (no pain, no disability) to 24 (maximum pain, stiffness and disability), and its reliability was 0.95.	baseline before the first injection
Primary	Lequesne index	The Lequesne index questionnaire included 10 questions about pain, stiffness and function. The score ranges from 0 (no pain, no disability) to 24 (maximum pain, stiffness and disability), and its reliability was 0.95.	1 week after the first injection
Primary	Lequesne index	The Lequesne index questionnaire included 10 questions about pain, stiffness and function. The score ranges from 0 (no pain, no disability) to 24 (maximum pain, stiffness and disability), and its reliability was 0.95.	2 weeks after the first injection
Primary	Lequesne index	The Lequesne index questionnaire included 10 questions about pain, stiffness and function. The score ranges from 0 (no pain, no disability) to 24 (maximum pain, stiffness and disability), and its reliability was 0.95.	3 weeks after the first injection
Primary	Lequesne index	The Lequesne index questionnaire included 10 questions about pain, stiffness and function. The score ranges from 0 (no pain, no disability) to 24 (maximum pain, stiffness and disability), and its reliability was 0.95.	4 weeks after the first injection
Primary	Lequesne index	The Lequesne index questionnaire included 10 questions about pain, stiffness and function. The score ranges from 0 (no pain, no disability) to 24 (maximum pain, stiffness and disability), and its reliability was 0.95.	5 weeks after the first injection
Primary	Lequesne index	The Lequesne index questionnaire included 10 questions about pain, stiffness and function. The score ranges from 0 (no pain, no disability) to 24 (maximum pain, stiffness and disability), and its reliability was 0.95.	14 weeks after the first injection
Primary	Lequesne index	The Lequesne index questionnaire included 10 questions about pain, stiffness and function. The score ranges from 0 (no pain, no disability) to 24 (maximum pain, stiffness and disability), and its reliability was 0.95.	24 weeks after the first injection