NCT03290365

Brief Summary

Although platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for osteoarthritis of knee (OA knee), the combined effect of PRP with HA was not clear so far. Hence, investigator assess a prospective randomized double-blind controlled trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 10, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

3.5 years

First QC Date

September 19, 2017

Last Update Submit

July 10, 2021

Conditions

Knee Osteoarthritis

Keywords

Platelet rich plasmaOsteoarthritis of kneeHyaluronic acid

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in severity of symptoms and functional status on 1st month, 3rd month, 6th month and one year after injection.

    Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to measure the symptoms and functional status before treatment and multiple time frame after treatment. Both subscales has the scores ranged from 1 to 5 for each item and a higher score indicating more severe of symptom or impaired functional status.

    Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.

Secondary Outcomes (4)

  • Change from baseline in severity of symptoms and functional status on 1st month, 3rd month, 6th month and one year after injection.

    Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.

  • Change from baseline of pain on 1st month, 3rd month, 6th month and one year after injection.

    Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.

  • Change from baseline in balance function on 1st month, 3rd month, 6th month and one year after injection.

    Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.

  • Change from baseline in analysis of synovial fluid on 6th month and one year after injection.

    Pre-treatment, 6th month and one year after injection.

Study Arms (2)

Platelet rich plasma + Hyaluronic acid

ACTIVE COMPARATOR

Platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee. Patients received one dose of PRP injection. One week later, the one dose of HA is injected for intervention group.

Drug: platelet rich plasma + Hyaluronic acid

Platelet rich plasma + normal saline

PLACEBO COMPARATOR

Patients received one dose of PRP injection. One week later, the one dose of normal saline is injected for control group.

Drug: platelet rich plasma + normal saline

Interventions

platelet rich plasma + Hyaluronic acidDRUG

Platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee.

Platelet rich plasma + Hyaluronic acid
platelet rich plasma + normal salineDRUG

The normal salin as the placebo intervention was injection control group.

Platelet rich plasma + normal saline

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 50 to 75 y/o.
  • Alert consciousness
  • Symptom of knee osteoarthritis persist at least 6 months and stage I to III scored by Ahlbäck grading system
  • The pain score measured by VAS at least 4 points

You may not qualify if:

  • Has received hyaluronic acid, PRP or steroid injection within 6 months
  • Has received NSAIDs or steroid within one week
  • Tumor or metastasis surrounding the knee joint
  • Has received total knee replacement, major surgery in knee, rheumatoid arthritis
  • Patient who cant tolerance the balance test.
  • Thrombocytopenia or coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Taipei, Neihu District, 886, Taiwan

Location

Related Publications (4)

  • Abate M, Verna S, Schiavone C, Di Gregorio P, Salini V. Efficacy and safety profile of a compound composed of platelet-rich plasma and hyaluronic acid in the treatment for knee osteoarthritis (preliminary results). Eur J Orthop Surg Traumatol. 2015 Dec;25(8):1321-6. doi: 10.1007/s00590-015-1693-3. Epub 2015 Sep 24.

    PMID: 26403468RESULT

  • Lana JF, Weglein A, Sampson SE, Vicente EF, Huber SC, Souza CV, Ambach MA, Vincent H, Urban-Paffaro A, Onodera CM, Annichino-Bizzacchi JM, Santana MH, Belangero WD. Randomized controlled trial comparing hyaluronic acid, platelet-rich plasma and the combination of both in the treatment of mild and moderate osteoarthritis of the knee. J Stem Cells Regen Med. 2016 Nov 29;12(2):69-78. doi: 10.46582/jsrm.1202011. eCollection 2016.

    PMID: 28096631RESULT

  • Chen SH, Kuan TS, Kao MJ, Wu WT, Chou LW. Clinical effectiveness in severe knee osteoarthritis after intra-articular platelet-rich plasma therapy in association with hyaluronic acid injection: three case reports. Clin Interv Aging. 2016 Sep 8;11:1213-1219. doi: 10.2147/CIA.S114795. eCollection 2016.

    PMID: 27660427RESULT

  • Dallari D, Stagni C, Rani N, Sabbioni G, Pelotti P, Torricelli P, Tschon M, Giavaresi G. Ultrasound-Guided Injection of Platelet-Rich Plasma and Hyaluronic Acid, Separately and in Combination, for Hip Osteoarthritis: A Randomized Controlled Study. Am J Sports Med. 2016 Mar;44(3):664-71. doi: 10.1177/0363546515620383. Epub 2016 Jan 21.

    PMID: 26797697RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic AcidSaline Solution

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Yung-Tsan Wu, MD

    Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

September 19, 2017

First Posted

September 21, 2017

Study Start

January 10, 2018

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

July 13, 2021

Record last verified: 2021-07

Locations

TW(1)