NCT02448407

Brief Summary

Platelet-rich plasma (PRP), due to its high content of cytokines, bioactive proteins and platelet growth factors, may contribute to diminish the pain of arthritic knee. It was also recently recognized a regenerative cell potential improving the concentration of hyaluronic acid and stabilizing angiogenesis in arthritic knees This study therefore seeks to assess the analgesic power of PRP in osteoarthritic knees intraarticularly infiltrated, and which patients would benefit most from treatment, eliminating false expectations in the rest.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at below P25 for phase_3 knee-osteoarthritis

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_3 knee-osteoarthritis

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
Last Updated

May 19, 2015

Status Verified

February 1, 2015

Enrollment Period

5 months

First QC Date

April 27, 2015

Last Update Submit

May 15, 2015

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritisPlatelet-rich plasmaPain's treatment

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline Visual Analogue Scale (VAS) value

    The main objective of this study is to determine the clinical value of intraarticular injections of platelet-rich plasma (PRP) in the reduction of perceived pain in patients with osteoarthritic knees

    Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration

Secondary Outcomes (3)

  • Changes from baseline Knee and Osteoarthritis Outcome System (KOOS) scale value

    Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration

  • Effects on quality of life

    Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration

  • All reported adverse events

    Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration

Study Arms (2)

Platelet rich plasma

EXPERIMENTAL

Three intraarticular injection, one each fifteen days

Biological: Platelet rich plasma

Hyaluronic acid

ACTIVE COMPARATOR

Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1 % solution, administered by intraarticular injection (3 doses, one each fifteen days)

Drug: Hyaluronic acid

Interventions

Platelet rich plasmaBIOLOGICAL

Three intraarticular injections of platelet-rich plasma, one each fifteen days

Also known as: PRP, Platelet Concentrate
Platelet rich plasma
Hyaluronic acidDRUG

Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1% solution, administered by intraarticular injections (three doses, one each fifteen days)

Also known as: Adant
Hyaluronic acid

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Arthritis in the knee rated I, II, or III (Kellgren-Lawrence Grading Scale)
  • VAS greater than 5
  • Between 40and 80 years of age

You may not qualify if:

  • Level IV arthritis of the knee
  • Either surgery, corticoid infiltration, or viscosupplementation in the knee in the previous three months
  • Frontal deformity greater than 10 degrees
  • Ipsilateral pathology of the knee or ankle
  • Range of motion or flexibility of the knee less than 90 degrees
  • Deficit of knee extension greater than 15 degrees
  • Anticoagulation treatment, antiplatelet treatment
  • Hepatopathy
  • Hematological neoplastic pathology
  • Active infection
  • Fibromyalgia
  • Chronic fatigue syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Elvira Montañez Heredia, MD, PhD

    Hospital Universitario Virgen de la Victoria. Málaga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2015

First Posted

May 19, 2015

Study Start

January 1, 2014

Primary Completion

June 1, 2014

Study Completion

November 1, 2014

Last Updated

May 19, 2015

Record last verified: 2015-02