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Platelet-rich Plasma Intra-articular Knee Injections for Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
platelet-rich plasma
Corticosteroid
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, comparing platelet-rich plasma, intra-articular knee injections

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Degenerative osteoarthritis of the knee confirmed radiologically
  • Degenerative osteoarthritis of the knee replacement candidate
  • Walking ability in patients with or without external support
  • Baseline in pain VAS greater than 60

Exclusion Criteria:

  • Neoplastic disease
  • Immunosuppressive States
  • Patients who received intra-articular injections of steroids, anesthetic and / or hyaluronic acid in the last 3 months.
  • Patients who have undergone arthroscopic surgery on the last 3 months
  • Patients with involvement of bone metabolism except osteoporosis (Paget's disease, renal osteodystrophy, osteomalacia)
  • Fibromyalgia or chronic fatigue syndrome
  • Liver disease
  • Deficit coagulation (blood dyscrasia)
  • Thrombocytopenia
  • Anticoagulant treatment

Sites / Locations

  • Hospital Universitario Vall d'Hebron

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

platelet-rich plasma intra-articular knee injections

Corticosteroid intra-articular knee injections

Arm Description

a single intra-articular injection of PRP in knee osteoarthritis

a betamethasone and bupivacaine intra-articular injection

Outcomes

Primary Outcome Measures

The value of the visual analogue scale pain (VAS)
The difference between the baseline and the value of the scale one month after treatment

Secondary Outcome Measures

the value of pain visual analog scale according to
the functional level of the knee KOOS
All reported adverse events
Scale of the SF36 quality of life

Full Information

First Posted
June 23, 2011
Last Updated
February 23, 2015
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01381081
Brief Title
Platelet-rich Plasma Intra-articular Knee Injections for Knee Osteoarthritis
Official Title
A Prospective, Randomized, Double-blinded, Clinical Trial, Comparing Platelet-rich Plasma Intra-articular Knee Injections Versus Corticosteroid Intra-articular Knee Injections for Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The benefit of using platelet rich plasma (PRP) in cartilage injuries, and specifically in degenerative ones, has not been assessed yet. Current studies on the PRP healing or repairing effect on knee cartilage degenerative injuries are not conclusive to establish a standard of behavior, although PRP has shown to improve joint functionality and reduce pain. Hypothesis: PRP intra-articular injections in osteoarthritic knees reduces pain and leads to a more effective and lasting functional recovering than corticosteroid intra-articular injections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, comparing platelet-rich plasma, intra-articular knee injections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
platelet-rich plasma intra-articular knee injections
Arm Type
Experimental
Arm Description
a single intra-articular injection of PRP in knee osteoarthritis
Arm Title
Corticosteroid intra-articular knee injections
Arm Type
Active Comparator
Arm Description
a betamethasone and bupivacaine intra-articular injection
Intervention Type
Biological
Intervention Name(s)
platelet-rich plasma
Intervention Description
a single intra-articular injection
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Intervention Description
A single betamethasone and bupivacaine intra-articular injection
Primary Outcome Measure Information:
Title
The value of the visual analogue scale pain (VAS)
Description
The difference between the baseline and the value of the scale one month after treatment
Time Frame
one month after the treatment
Secondary Outcome Measure Information:
Title
the value of pain visual analog scale according to
Time Frame
4 weeks, 3 and 6 months after treatment
Title
the functional level of the knee KOOS
Time Frame
4 weeks, 3 and 6 months after treatment
Title
All reported adverse events
Time Frame
4 weeks, 3 and 6 months after treatment
Title
Scale of the SF36 quality of life
Time Frame
4 weeks, 3 and 6 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Degenerative osteoarthritis of the knee confirmed radiologically Degenerative osteoarthritis of the knee replacement candidate Walking ability in patients with or without external support Baseline in pain VAS greater than 60 Exclusion Criteria: Neoplastic disease Immunosuppressive States Patients who received intra-articular injections of steroids, anesthetic and / or hyaluronic acid in the last 3 months. Patients who have undergone arthroscopic surgery on the last 3 months Patients with involvement of bone metabolism except osteoporosis (Paget's disease, renal osteodystrophy, osteomalacia) Fibromyalgia or chronic fatigue syndrome Liver disease Deficit coagulation (blood dyscrasia) Thrombocytopenia Anticoagulant treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nayana Joshi, MD
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

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Platelet-rich Plasma Intra-articular Knee Injections for Knee Osteoarthritis

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