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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT01381081
First received: June 23, 2011
Last updated: September 9, 2013
Last verified: September 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • the functional level of the knee KOOS [ Time Frame: 4 weeks, 3 and 6 months after treatment ] [ Designated as safety issue: No ]
  • All reported adverse events [ Time Frame: 4 weeks, 3 and 6 months after treatment ] [ Designated as safety issue: Yes ]
  • Scale of the SF36 quality of life [ Time Frame: 4 weeks, 3 and 6 months after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: July 2011
Estimated Study Completion Date: April 2014
Estimated 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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01381081     History of Changes
Other Study ID Numbers: PRP2010, 2010-023977-21
Study First Received: June 23, 2011
Last Updated: September 9, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

ClinicalTrials.gov processed this record on August 01, 2014