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Comparing Efficacy of PRP Combined With Different Hyaluronan for the Treatment of Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
PRP+Artz group
PRP+ HYAJOINT Plus group
Sponsored by
Kaohsiung Veterans General Hospital.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Hyaluronic acid, Knee, Osteoarthritis, Platelet-rich plasma

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age of 20-85 years Symptomatic knee osteoarthritis for more than 6 months despite analgesics, NSAIDs, or physical therapy Kellgren-Lawrence grade-2 knee osteoarthritis seen on radiographs made within previous 6 months Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee was less than 30 mm.

Exclusion Criteria:

  • Previous orthopedic surgery on spine or lower limb Disabling osteoarthritis of either hip or foot Knee instability, apparent joint effusion, or marked valgus/varus deformity Known allergy to avian proteins or hyaluronan products Confirmed or suspected pregnancy, or lactating Intra-articular injections into knee in previous 6 months Any specific medical conditions (rheumatoid arthritis, active infection, hemiparesis, neoplasm, hematological etc.) that would interfere with assessments

Sites / Locations

  • Kaohsiung Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

the PRP+Artz group

the PRP+HYAJOINT Plus group

Arm Description

The patients in the PRP+Artz group received one intraarticular Artz injection (2.5 ml) followed consecutively by one intraarticular injection of PRP (3ml).

The patients in the PRP+HYAJOINT Plus group received one intraarticular HYAJOINT Plus injection (3ml) followed by one intraarticular injection of PRP (3ml).

Outcomes

Primary Outcome Measures

visual analog scale (VAS) pain change
the change from baseline in the visual analog scale (VAS) pain score at 6 months. The patient rated the average severity of knee pain on knee movement over the previous week on a 0-100 mm VAS (0 = no pain to 100 = worst possible pain)

Secondary Outcome Measures

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert Scale), t
(WOMAC, Likert Scale) is a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Total score is 96 and higher scores indicate worse outcomes.
the Lequesne index
Lequesne index was used to assess severity of knee symptoms during the last week. It includes the measurement of pain, walking distance, and activities of daily living. Maximal score is 24 and higher scores represent worse function.
single-leg stance test (SLS)
Single-leg stance test (SLS) is done by raising one foot up without touching it to the supported lower extremity with target knee and maintain balance for as long as possible. Each participant performed 3 trials, and the best result of the 3 trials was recorded.
patient satisfaction.
Patients were asked to rate their treatment satisfaction compared to the preinjection condition, using a 100 mm VAS (0= completely dissatisfied, 100=completely satisfied).
consumption of analgesics
Acetaminophen (500mg; maximum daily dose, 4 g) was the only rescue medication allowed for knee pain during the study period, Use of rescue medication during the study period was recorded in a patient diary.

Full Information

First Posted
June 10, 2021
Last Updated
June 16, 2021
Sponsor
Kaohsiung Veterans General Hospital.
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1. Study Identification

Unique Protocol Identification Number
NCT04931719
Brief Title
Comparing Efficacy of PRP Combined With Different Hyaluronan for the Treatment of Knee Osteoarthritis
Official Title
Comparing Efficacy of Platelet-rich Plasma (PRP) Combined With Different Hyaluronan for the Treatment of Knee Osteoarthritis: a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Either PRP or HA is each effective for treating knee OA. However, the efficacy of combined PRP and HA injections remains unknown clinically.
Detailed Description
Intraarticular plasma-rich platelet (PRP) or hyaluronic acid (HA) was each effective for knee osteoarthritis(OA). The efficacy of combined injections remains unknown. This study aimed to evaluate the efficacy of PRP combined with different hyaluronan for treating knee OA. In a prospective, randomized-controlled trial, 95 patients with Kellgren-Lawrence grade 2 knee OA were randomized to receive a single intraarticular Artz (10mg/ml) followed by PRP (N=48) into target knee or single HYAJOINT Plus (20mg/ml) injection followed by PRP (N=47). Primary outcome was the change from baseline in the visual analog scale (VAS) pain at 6 months. Secondary outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne index, single leg stance test (SLS), use of rescue analgesics and patient satisfaction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Hyaluronic acid, Knee, Osteoarthritis, Platelet-rich plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The purpose of this study was to compare the efficacy of a single Artz injection followed by PRP with a single HYAJOINT Plus injection followed by PRP in the management of knee OA.
Masking
ParticipantOutcomes Assessor
Masking Description
One of the investigator, blinded to the allocation groups, performed all the assessments. The patients were blinded, by preventing visual access to the injection field with a screen placed between them and their knee during the injection process. They were not informed of which HA they had received during the study period.
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the PRP+Artz group
Arm Type
Active Comparator
Arm Description
The patients in the PRP+Artz group received one intraarticular Artz injection (2.5 ml) followed consecutively by one intraarticular injection of PRP (3ml).
Arm Title
the PRP+HYAJOINT Plus group
Arm Type
Experimental
Arm Description
The patients in the PRP+HYAJOINT Plus group received one intraarticular HYAJOINT Plus injection (3ml) followed by one intraarticular injection of PRP (3ml).
Intervention Type
Combination Product
Intervention Name(s)
PRP+Artz group
Intervention Description
The patients in the PRP+Artz group received one intraarticular Artz injection (2.5 ml) followed consecutively by one intraarticular injection of PRP (3ml).
Intervention Type
Combination Product
Intervention Name(s)
PRP+ HYAJOINT Plus group
Intervention Description
The patients in the PRP+HYAJOINT Plus group received one intraarticular HYAJOINT Plus injection (3ml) followed by one intraarticular injection of PRP (3ml).
Primary Outcome Measure Information:
Title
visual analog scale (VAS) pain change
Description
the change from baseline in the visual analog scale (VAS) pain score at 6 months. The patient rated the average severity of knee pain on knee movement over the previous week on a 0-100 mm VAS (0 = no pain to 100 = worst possible pain)
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert Scale), t
Description
(WOMAC, Likert Scale) is a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Total score is 96 and higher scores indicate worse outcomes.
Time Frame
Month 6
Title
the Lequesne index
Description
Lequesne index was used to assess severity of knee symptoms during the last week. It includes the measurement of pain, walking distance, and activities of daily living. Maximal score is 24 and higher scores represent worse function.
Time Frame
Month 6
Title
single-leg stance test (SLS)
Description
Single-leg stance test (SLS) is done by raising one foot up without touching it to the supported lower extremity with target knee and maintain balance for as long as possible. Each participant performed 3 trials, and the best result of the 3 trials was recorded.
Time Frame
Month 6
Title
patient satisfaction.
Description
Patients were asked to rate their treatment satisfaction compared to the preinjection condition, using a 100 mm VAS (0= completely dissatisfied, 100=completely satisfied).
Time Frame
Month 6
Title
consumption of analgesics
Description
Acetaminophen (500mg; maximum daily dose, 4 g) was the only rescue medication allowed for knee pain during the study period, Use of rescue medication during the study period was recorded in a patient diary.
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of 20-85 years Symptomatic knee osteoarthritis for more than 6 months despite analgesics, NSAIDs, or physical therapy Kellgren-Lawrence grade-2 knee osteoarthritis seen on radiographs made within previous 6 months Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee was less than 30 mm. Exclusion Criteria: Previous orthopedic surgery on spine or lower limb Disabling osteoarthritis of either hip or foot Knee instability, apparent joint effusion, or marked valgus/varus deformity Known allergy to avian proteins or hyaluronan products Confirmed or suspected pregnancy, or lactating Intra-articular injections into knee in previous 6 months Any specific medical conditions (rheumatoid arthritis, active infection, hemiparesis, neoplasm, hematological etc.) that would interfere with assessments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu-Fen Sun
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33420185
Citation
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Results Reference
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Comparing Efficacy of PRP Combined With Different Hyaluronan for the Treatment of Knee Osteoarthritis

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