The Synergistic Effects of Intra-articular Hyaluronic Acid and Platelet-rich Plasma Injections on Knee Osteoarthritis (HAPRP)
Primary Purpose
Osteoarthritis Knees Both
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
A platelet-rich plasma (PRP)+ hyaluronic acid (HA) program
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis Knees Both
Eligibility Criteria
Inclusion Criteria:
- The study will recruit persons aged between 50 and 80 years who have experienced symptomatic knee OA for 6 months or more. They have a radiographic picture of knee OA of grades 1-3, based on the Kellegren-Lawrence scale.
Exclusion Criteria:
- Those who have diabetes, fever, anemia (Hb <10 g/dl), thrombocytopenia (platelet count <150000/ml), a blood-clotting disease, knee deformity (genu valgum/varum >20 degrees), impaired leg mobility secondary to neuromuscular diseases or a bony fracture, impaired mental function who have difficulty in completing outcome assessments, severe cardiopulmonary impairment, taking anticoagulants long-term, a history of intra-articular steroid injection in the prior 1 year, a history of knee injury involving ligaments and menisci, and a history of malignancy are excluded.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
At the beginning of the study (T0), group A will receive one course of PRP+HA program and group B will receive one HA course (a single HA injection (Hyajoint) weekly for 3 weeks). The PRP+HA program includes 3 HA injections and a single PRP injection (Arthrex double syringe system).
In the 6th month, alternately, group B will receive one PRP+HA program and group A will receive one HA course.
Outcomes
Primary Outcome Measures
changes in WOMAC index
a self-administered Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
changes in quadriceps strength
measurement of quadriceps strength with a digital handheld dynamometer
changes in cartilage thickness
measurement of femoral condylar cartilage thickness with musculoskeletal ultrasound
Secondary Outcome Measures
Full Information
NCT ID
NCT04443166
First Posted
June 10, 2020
Last Updated
June 22, 2020
Sponsor
Taipei Medical University WanFang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04443166
Brief Title
The Synergistic Effects of Intra-articular Hyaluronic Acid and Platelet-rich Plasma Injections on Knee Osteoarthritis
Acronym
HAPRP
Official Title
The Synergistic Effects of Intra-articular Hyaluronic Acid and Platelet-rich Plasma Injections on Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University WanFang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Although intra-articular knee injection with platelet-rich plasma (PRP) may have better outcomes than using hyaluronic acid (HA) for people with knee osteoarthritis (OA), it is expensive to use PRP. Programs with a combination of PRP and HA (PRP+HA) showed good results in vitro and animal studies. This 2-year study aims to clarify the short- and long-term effectiveness of the PRP+HA program for knee OA.
The study will recruit 60 persons aged between 50 and 80 years who have experienced symptomatic knee OA for 6 months or more and have a radiographic picture of knee OA of grades 1-3, based on the Kellegren-Lawrence scale. Those who have diabetes, fever, anemia (Hb <10 g/dl), thrombocytopenia (platelet count <150000/ml), a blood-clotting disease, knee deformity (genu valgum/varum >20 degrees), impaired leg mobility secondary to neuromuscular diseases or a bony fracture, impaired mental function, severe cardiopulmonary impairment, taking anticoagulants long-term, a history of intra-articular steroid injection in the prior 1 year, a history of knee injury involving ligaments and menisci, and a history of malignancy are excluded.
All participants will be randomly divided into group A and group B. At the beginning of the study (T0), group A will receive one course of PRP+HA program and group B will receive one HA course (a single HA injection (Hyajoint) weekly for 3 weeks). The PRP+HA program includes 3 HA injections and a single PRP injection (Arthrex double syringe system). In the 6th month, alternately, group B will receive one PRP+HA program and group A will receive one HA course. The study has 3 outcome assessment tools including a self-administered Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, measurement of quadriceps strength with a digital handheld dynamometer, and measurement of femoral condylar cartilage thickness with musculoskeletal ultrasound. The investigators will conduct those assessments in the beginning (T0) of the study and the following 1st (T1), 3rd (T2), 6th (T3), and 9th (T4) months.
In the 18th month following the beginning of the study, both groups will receive a booster course of PRP+HA program. During the first week of the program, group A will receive a HA injection before the PRP injection and group B will receive the HA injection after the PRP injection. The investigators will conduct the long-term assessments in the 12th (T5), 15th (T6), 18th (T7), and 21st (T8) months since the beginning of the study.
Detailed Description
People aged >65 years are over 14% in Taiwan since the year 2018. Knee osteoarthritis (OA) is prevalent among elderly people. People with knee OA often have knee pain and stiffness as well as compromised their walking performance and quality of daily life. Although intra-articular knee injection with platelet-rich plasma (PRP) may have better outcomes than using hyaluronic acid (HA), it is expensive to use PRP. Programs with a combination of PRP and HA (PRP+HA) showed good results in vitro and animal studies. This 2-year study aims to clarify the short- and long-term effectiveness of the PRP+HA program for knee OA. The study will also assess the effectiveness of a booster course of PRP+HA program in the second year.
The study will recruit 60 persons aged between 50 and 80 years who have experienced symptomatic knee OA for 6 months or more and have a radiographic picture of knee OA of grades 1-3, based on the Kellegren-Lawrence scale. Those who have diabetes, fever, anemia (Hb <10 g/dl), thrombocytopenia (platelet count <150000/ml), a blood-clotting disease, knee deformity (genu valgum/varum >20 degrees), impaired leg mobility secondary to neuromuscular diseases or a bony fracture, impaired mental function who have difficulty in completing outcome assessments, severe cardiopulmonary impairment, taking anticoagulants long-term, a history of intra-articular steroid injection in the prior 1 year, a history of knee injury involving ligaments and menisci, and a history of malignancy are excluded.
All participants will be randomly divided into group A and group B. At the beginning of the study (T0), group A will receive one course of PRP+HA program and group B will receive one HA course (a single HA injection (Hyajoint) weekly for 3 weeks). The PRP+HA program includes 3 HA injections and a single PRP injection (Arthrex double syringe system). In the 6th month, alternately, group B will receive one PRP+HA program and group A will receive one HA course. The study has 3 outcome assessment tools including a self-administered Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, measurement of quadriceps strength with a digital handheld dynamometer, and measurement of femoral condylar cartilage thickness with musculoskeletal ultrasound. The investigators will conduct those assessments in the beginning (T0) of the study and the following 1st (T1), 3rd (T2), 6th (T3), and 9th (T4) months.
In the 18th month following the beginning of the study, both groups will receive a booster course of PRP+HA program. During the first week of the program, group A will receive a HA injection before the PRP injection and group B will receive the HA injection after the PRP injection. The investigators will conduct the long-term assessments in the 12th (T5), 15th (T6), 18th (T7), and 21st (T8) months since the beginning of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Knees Both
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
At the beginning of the study (T0), group A will receive one course of PRP+HA program and group B will receive one HA course (a single HA injection (Hyajoint) weekly for 3 weeks). The PRP+HA program includes 3 HA injections and a single PRP injection (Arthrex double syringe system).
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
In the 6th month, alternately, group B will receive one PRP+HA program and group A will receive one HA course.
Intervention Type
Combination Product
Intervention Name(s)
A platelet-rich plasma (PRP)+ hyaluronic acid (HA) program
Other Intervention Name(s)
A hyaluronic acid (HA) course (a single HA injection (Hyajoint) weekly for 3 weeks)
Intervention Description
a combination of intra-articular knee injection with platelet-rich plasma (PRP) and hyaluronic acid (HA)
Primary Outcome Measure Information:
Title
changes in WOMAC index
Description
a self-administered Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
Time Frame
in the beginning (T0) of the study and the following 1st (T1), 3rd (T2), 6th (T3), 9th (T4), 12th (T5), 15th (T6), 18th (T7), and 21st (T8) months.
Title
changes in quadriceps strength
Description
measurement of quadriceps strength with a digital handheld dynamometer
Time Frame
in the beginning (T0) of the study and the following 1st (T1), 6th (T3), 12th (T5), 18th (T7), and 21st (T8) months.
Title
changes in cartilage thickness
Description
measurement of femoral condylar cartilage thickness with musculoskeletal ultrasound
Time Frame
in the beginning (T0) of the study and the following 1st (T1), 6th (T3), 12th (T5), 18th (T7), and 21st (T8) months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The study will recruit persons aged between 50 and 80 years who have experienced symptomatic knee OA for 6 months or more. They have a radiographic picture of knee OA of grades 1-3, based on the Kellegren-Lawrence scale.
Exclusion Criteria:
Those who have diabetes, fever, anemia (Hb <10 g/dl), thrombocytopenia (platelet count <150000/ml), a blood-clotting disease, knee deformity (genu valgum/varum >20 degrees), impaired leg mobility secondary to neuromuscular diseases or a bony fracture, impaired mental function who have difficulty in completing outcome assessments, severe cardiopulmonary impairment, taking anticoagulants long-term, a history of intra-articular steroid injection in the prior 1 year, a history of knee injury involving ligaments and menisci, and a history of malignancy are excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kwang-Hwa Chang, MD
Phone
+886-2-29307930
Ext
1610
Email
chang2773@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwang-Hwa Chang, MD
Organizational Affiliation
Prof.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Synergistic Effects of Intra-articular Hyaluronic Acid and Platelet-rich Plasma Injections on Knee Osteoarthritis
We'll reach out to this number within 24 hrs