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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01381081
First Posted: June 27, 2011
Last Update Posted: February 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis Biological: platelet-rich plasma Drug: Corticosteroid Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • The value of the visual analogue scale pain (VAS) [ Time Frame: one month after the treatment ]
    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 [ Time Frame: 4 weeks, 3 and 6 months after treatment ]
  • the functional level of the knee KOOS [ Time Frame: 4 weeks, 3 and 6 months after treatment ]
  • All reported adverse events [ Time Frame: 4 weeks, 3 and 6 months after treatment ]
  • Scale of the SF36 quality of life [ Time Frame: 4 weeks, 3 and 6 months after treatment ]

Enrollment: 74
Study Start Date: July 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: platelet-rich plasma intra-articular knee injections
a single intra-articular injection of PRP in knee osteoarthritis
Biological: platelet-rich plasma
a single intra-articular injection
Active Comparator: Corticosteroid intra-articular knee injections
a betamethasone and bupivacaine intra-articular injection
Drug: Corticosteroid
A single betamethasone and bupivacaine intra-articular injection

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01381081


Locations
Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
Principal Investigator: Nayana Joshi, MD Hospital Vall d'Hebron
  More Information

Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01381081     History of Changes
Other Study ID Numbers: PRP2010
2010-023977-21 ( EudraCT Number )
First Submitted: June 23, 2011
First Posted: June 27, 2011
Last Update Posted: February 24, 2015
Last Verified: February 2015

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
knee osteoarthritis
comparing platelet-rich plasma
intra-articular knee injections

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases