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

NCT01381081 | Completed Phase 3

• 2 other identifiers: PRP20102010-023977-21
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; comparing platelet-rich plasma; intra-articular knee injections

Outcome Measures

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

  one month after the treatment

Secondary Outcomes (4)

• the value of pain visual analog scale according to

  4 weeks, 3 and 6 months after treatment

• the functional level of the knee KOOS

  4 weeks, 3 and 6 months after treatment

• All reported adverse events

  4 weeks, 3 and 6 months after treatment

• Scale of the SF36 quality of life

  4 weeks, 3 and 6 months after treatment

Study Arms (2)

platelet-rich plasma intra-articular knee injections

EXPERIMENTAL

a single intra-articular injection of PRP in knee osteoarthritis

Biological: platelet-rich plasma

Corticosteroid intra-articular knee injections

ACTIVE COMPARATOR

a betamethasone and bupivacaine intra-articular injection

Drug: Corticosteroid

Interventions

platelet-rich plasma BIOLOGICAL

a single intra-articular injection

platelet-rich plasma intra-articular knee injections

Corticosteroid DRUG

A single betamethasone and bupivacaine intra-articular injection

Corticosteroid intra-articular knee injections

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitario Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Nayana Joshi, MD

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: June 27, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 24, 2015

Record last verified: 2015-02

Locations

ES (1)