NCT03197441

Brief Summary

This study aimed to analyze the effect of platelet-rich plasma (PRP) on knee osteoarthritis. Eligible patients will undertake arthroscopic knee surgery plus intraoperative PRP and also receive second look surgery and intraoperative biopsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

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

Study Start

First participant enrolled

August 29, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2018

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

1.8 years

First QC Date

April 13, 2017

Last Update Submit

September 5, 2019

Conditions

Osteo Arthritis KneePlatelet-rich Plasma

Keywords

Platelet-rich plasmaOsteoarthritis Knee

Outcome Measures

Primary Outcomes (1)

  • Change in knee function from baseline to postoperative 3 months

    Knee function is evaluated using Oswestry Disability Index preoperatively and 3-month postoperatively.

    3-month postoperative

Secondary Outcomes (7)

  • Change in knee function from baseline to postoperative 6 months

    6-month postoperative

  • Change in knee function from baseline to postoperative 12 months

    12-month postoperative

  • Change in knee pain from baseline to postoperative 3 months

    3-month postoperative

  • Change in knee pain from baseline to postoperative 6 months

    6-month postoperative

  • Change in knee pain from baseline to postoperative 12 months

    12-month postoperative

  • +2 more secondary outcomes

Study Arms (1)

PRP group

EXPERIMENTAL

Arthroscopic knee surgery plus intraoperative platelet-rich plasma

Other: Platelet-rich plasma

Interventions

Platelet-rich plasmaOTHER

Intraoperative platelet-rich plasma injection during arthroscopic knee surgery

PRP group

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 30 and 70 years
  • With diagnosis of osteoarthritis, grade II\~grade IV, II-III medial compartment

You may not qualify if:

  • Lateral compartment and patellofemoral joint osteoarthritis
  • With prior history of knee surgery
  • Severe varus deformity
  • With current or prior history of traum or infection at the knee
  • With current or prior history of cancer
  • With current or prior history of hematological disease
  • Pregnancy
  • Patients who will not cooperate with one-year followup

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Show Chwan Memorial Hospital

Changhua, Changhua, 500, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Pei-Yuan Lee, MD

    Show Chwan Memorial Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Superintendent

Study Record Dates

First Submitted

April 13, 2017

First Posted

June 23, 2017

Study Start

August 29, 2016

Primary Completion

June 28, 2018

Study Completion

June 28, 2018

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)