The Synergistic Effects of Intra-articular Hyaluronic Acid and Platelet-rich Plasma Injections on Knee Osteoarthritis

NCT04443166 | Unknown FDA Device

• 1 other identifier: N202002101
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis Knees Both

Outcome Measures

Primary Outcomes (3)

• changes in WOMAC index

  a self-administered Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index

  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.

• changes in quadriceps strength

  measurement of quadriceps strength with a digital handheld dynamometer

  in the beginning (T0) of the study and the following 1st (T1), 6th (T3), 12th (T5), 18th (T7), and 21st (T8) months.

• changes in cartilage thickness

  measurement of femoral condylar cartilage thickness with musculoskeletal ultrasound

  in the beginning (T0) of the study and the following 1st (T1), 6th (T3), 12th (T5), 18th (T7), and 21st (T8) months.

Study Arms (2)

Group A

EXPERIMENTAL

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).

Combination Product: A platelet-rich plasma (PRP)+ hyaluronic acid (HA) program

Group B

ACTIVE COMPARATOR

In the 6th month, alternately, group B will receive one PRP+HA program and group A will receive one HA course.

Combination Product: A platelet-rich plasma (PRP)+ hyaluronic acid (HA) program

Interventions

A platelet-rich plasma (PRP)+ hyaluronic acid (HA) program COMBINATION_PRODUCT

a combination of intra-articular knee injection with platelet-rich plasma (PRP) and hyaluronic acid (HA)

Also known as: A hyaluronic acid (HA) course (a single HA injection (Hyajoint) weekly for 3 weeks)

Group A; Group B

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Officials

• Kwang-Hwa Chang, MD

  Prof.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kwang-Hwa Chang, MD

CONTACT

+886-2-29307930; chang2773@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 23, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share