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

NCT04443166 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-06-23

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

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

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

Sponsors & Collaborators

  • Taipei Medical University WanFang Hospital

    lead OTHER

Principal Investigators

  • Kwang-Hwa Chang, MD · Prof.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2021-06-30
Completion
2022-06-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04443166 on ClinicalTrials.gov