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

June 23, 2011
September 9, 2013
July 2011
January 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01381081 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Platelet-rich Plasma Intra-articular Knee Injections for Knee Osteoarthritis
A Prospective, Randomized, Double-blinded, Clinical Trial, Comparing Platelet-rich Plasma Intra-articular Knee Injections Versus Corticosteroid Intra-articular Knee Injections for Knee Osteoarthritis

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Knee Osteoarthritis
  • Biological: platelet-rich plasma
    a single intra-articular injection
  • Drug: Corticosteroid
    A single betamethasone and bupivacaine intra-articular injection
  • Experimental: platelet-rich plasma intra-articular knee injections
    a single intra-articular injection of PRP in knee osteoarthritis
    Intervention: Biological: platelet-rich plasma
  • Active Comparator: Corticosteroid intra-articular knee injections
    a betamethasone and bupivacaine intra-articular injection
    Intervention: Drug: Corticosteroid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
64
April 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01381081
PRP2010, 2010-023977-21
No
Hospital Universitari Vall d'Hebron Research Institute
Hospital Universitari Vall d'Hebron Research Institute
Not Provided
Principal Investigator: Nayana Joshi, MD Hospital Vall d'Hebron
Hospital Universitari Vall d'Hebron Research Institute
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP