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

Primary Purpose

Osteoarthritis, Knee, Hyaluronan

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
medial midpatellar (MMP) portal
anteromedial (AM) portal
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Viscosupplementation, Hyaluronate, Distribution, Knee osteoarthritis, Injection approach

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Nanfang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

AM groups in cadavers study

MMP groups in cadavers study

AM groups in random controlled trial

MMP groups in random controlled trial

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 30, 2018
Last Updated
July 16, 2018
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03600571
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 30, 2014 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Hyaluronan
Keywords
Viscosupplementation, Hyaluronate, Distribution, Knee osteoarthritis, Injection approach

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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).
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AM groups in cadavers study
Arm Type
Experimental
Arm 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.
Arm Title
MMP groups in cadavers study
Arm Type
Experimental
Arm 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.
Arm Title
AM groups in random controlled trial
Arm Type
Experimental
Arm 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.
Arm Title
MMP groups in random controlled trial
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
medial midpatellar (MMP) portal
Intervention Description
injection medial under horizontal patella midline was administrated with the lower limb extension
Intervention Type
Procedure
Intervention Name(s)
anteromedial (AM) portal
Intervention Description
injection medial from patella tendon towards intercondylar notch was performed with the target knee 90° flexion
Primary Outcome Measure Information:
Title
WOMAC (Likert version 3.1)
Description
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.
Time Frame
baseline before the first injection
Title
WOMAC (Likert version 3.1)
Description
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.
Time Frame
1 week after the first injection
Title
WOMAC (Likert version 3.1)
Description
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.
Time Frame
2 weeks after the first injection
Title
WOMAC (Likert version 3.1)
Description
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.
Time Frame
3 weeks after the first injection
Title
WOMAC (Likert version 3.1)
Description
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.
Time Frame
4 weeks after the first injection
Title
WOMAC (Likert version 3.1)
Description
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.
Time Frame
5 weeks after the first injection
Title
WOMAC (Likert version 3.1)
Description
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.
Time Frame
14 weeks after the first injection
Title
WOMAC (Likert version 3.1)
Description
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.
Time Frame
24 weeks after the first injection
Title
Lequesne index
Description
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.
Time Frame
baseline before the first injection
Title
Lequesne index
Description
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.
Time Frame
1 week after the first injection
Title
Lequesne index
Description
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.
Time Frame
2 weeks after the first injection
Title
Lequesne index
Description
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.
Time Frame
3 weeks after the first injection
Title
Lequesne index
Description
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.
Time Frame
4 weeks after the first injection
Title
Lequesne index
Description
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.
Time Frame
5 weeks after the first injection
Title
Lequesne index
Description
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.
Time Frame
14 weeks after the first injection
Title
Lequesne index
Description
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.
Time Frame
24 weeks after the first injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China

12. IPD Sharing Statement

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

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