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CompletedNCT01381081Updated Feb 24, 2015

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

A Phase 3 interventional study of platelet-rich plasma and Corticosteroid in Knee Osteoarthritis, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Completed at 1 site in Spain. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-02-24.

Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Knee Osteoarthritis

Keywords

  • knee osteoarthritis
  • comparing platelet-rich plasma
  • intra-articular knee injections
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In context

Osteoarthritis

4,397 studies on the registry are indexed under Osteoarthritis; 581 are open to participants now.

This study's enrollment of 74 is close to the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    platelet-rich plasma intra-articular knee injections

    a single intra-articular injection of PRP in knee osteoarthritis

    Biological: platelet-rich plasma

  • Active comparator
    Corticosteroid intra-articular knee injections

    a betamethasone and bupivacaine intra-articular injection

    Drug: Corticosteroid

Interventions

  • Biologicalplatelet-rich plasma

    a single intra-articular injection

  • DrugCorticosteroid

    A single betamethasone and bupivacaine intra-articular injection

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What researchers measure

Primary outcomes

  1. The value of the visual analogue scale pain (VAS)

    The difference between the baseline and the value of the scale one month after treatment

    Time frame: one month after the treatment

Secondary outcomes

  1. the value of pain visual analog scale according to

    Time frame: 4 weeks, 3 and 6 months after treatment

  2. the functional level of the knee KOOS

    Time frame: 4 weeks, 3 and 6 months after treatment

  3. All reported adverse events

    Time frame: 4 weeks, 3 and 6 months after treatment

  4. Scale of the SF36 quality of life

    Time frame: 4 weeks, 3 and 6 months after treatment

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Study locations

1 site
  • Hospital Universitario Vall d'Hebron
    Barcelona, 08035, Spain
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01381081
Lead sponsor
Hospital Universitari Vall d'Hebron Research Institute
Responsible party
Sponsor
First posted
Jun 27, 2011
Start date
Jul 2011
Primary completion
Jan 2014
Completion
Jan 2014
Last update
Feb 24, 2015

Study contacts

Nayana Joshi, MD
principal investigator · Hospital Vall d'Hebron

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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