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Platelet-rich Plasma (PRP) vs Viscosupplementation for the Treatment of Early Knee Articular Degenerative Pathology (PRP-012)

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ClinicalTrials.gov Identifier: NCT02135367
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Federica Balboni, Istituto Ortopedico Rizzoli

Brief Summary:

The investigators hypothesized that intra-articular injections of Platelet-rich Plasma (PRP) to treat knee degenerative articular cartilage pathology could determine pain relief and recovery of knee function with overall clinical outcome comparable or even better than viscosupplementation, which is a common injective approach applied in this kind of pathology. To this purpose the investigators designed a double blind randomized controlled trial comparing PRP vs viscosupplementation.

A power analysis has been performed for the primary endpoint of IKDC subjective score improvement at the 12-month follow-up for PRP. From a pilot study, a standard deviation of 15.2 points was found. With an alpha error of 0.05, a beta error of 0.2 and a minimal clinically significant difference of 6.7 points corresponding at 1/3 of the documented mean improvement, the minimum sample size was 83 for each group. Considering a possible drop out of 15%, 96 patients per group are required for total 192 patients, selected according to well-defined inclusion criteria (see 'Eligibility criteria' section). Patients are then assigned to two different treatment groups, according to a randomization list. The first group of treatment consists of three weekly intra-articular injections of autologous PRP obtained with the following procedure: a 150-ml autologous venous blood sample undergoes 2 centrifugations (the first at 1480 rpm for 6 minutes to separate erythrocytes, and a second at 3400 rpm for 15 minutes to concentrate platelets) to produced 20 ml of PRP. This unit of PRP is then divided into 4 small units of 5 ml each. One unit is sent to the laboratory for analysis of platelet concentration and for a quality test, 3 units are stored at -30° C.

The second treatment group consists of patients receiving three weekly injections of hyaluronic acid (Hyalubrix 30 mg/2ml, Fidia Farmaceutici Spa, Italy;Molecular Weight: 1500 kDa).

To guarantee the blinding of the patients, all of them undergo blood harvesting to obtain autologous PRP which will be used only in half of them, according to the aforementioned randomization list. One week after the PRP production, the injective treatment starts, with 3 weekly injections of PRP or HA. At the moment of the injection the syringe is properly covered to prevent the patient from discovering the substance he was receiving. After the injection, patients are sent home with instructions to limit the use of the leg for at least 24 h and to use cold therapy/ice on the affected area to relieve pain. During this period, the use of non-steroidal medication is forbidden.

Patients are prospectively evaluated basally and at 2, 6, and 12 months of follow-up using clinical subjective scores and objective parameters to determine clinical outcome (see 'Outcome measure' section). Patient satisfaction and adverse events will be also reported. All the clinical evaluations are performed by a medical staff not involved in the injective procedure, in order to keep the study double blinded. At the end of the study, the nature of the injected substance is revealed to the patients.


Condition or disease Intervention/treatment Phase
Knee Chondropathy Knee Early Osteoarthritis Biological: PRP Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Platelet-rich Plasma (PRP) vs Viscosupplementation for the Treatment of Early Knee Articular Degenerative Pathology: a Randomized Double-blind Controlled Trial
Actual Study Start Date : January 2013
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PRP
This group of patients will be treated by three weekly Platelet rich Plasma intra-articular injections in the knee.
Biological: PRP
injections of Platelet rich Plasma

Active Comparator: HA

This group of patients will be treated by three weekly hyaluronic acid (HA) intra-articular injections in the knee.

The HA used is Hyalubrix 30 mg/2ml (Fidia Farmaceutici Spa, Padova, Italy)

Biological: PRP
injections of Platelet rich Plasma




Primary Outcome Measures :
  1. IKDC (International Knee Documentation Committee) subjective score [ Time Frame: 12 months evaluation ]
    The primary outcome is the difference in IKDC-subjective score at 12 months' follow-up between treatment groups (visco-supplementation vs PRP)


Secondary Outcome Measures :
  1. VAS (Visual Analogue Scale) for General Health status [ Time Frame: 2-, 6-, 12- months evaluation ]
    Any inter-group difference in general health status, evaluated by a VAS, will be documented at 2-, 6- and 12-months' follow-up

  2. KOOS (Knee injury and Osteoarthritis Outcome Score) score [ Time Frame: 2-, 6-, 12- months evaluation ]
    Any inter-group difference in KOOS Score will be documented at 2-, 6- and 12-months' follow-up

  3. IKDC objective score [ Time Frame: 2-, 6-, 12- months evaluation ]
    Any inter-group difference in IKDC objective score will be documented at 2-, 6- and 12-months' follow-up

  4. Tegner Score [ Time Frame: 2-, 6-, 12- months evaluation ]
    Any inter-group difference in Tegner Score, will be documented at 2-, 6- and 12-months' follow-up

  5. Adverse events [ Time Frame: 2-, 6-, 12- months evaluation ]
    Any eventual adverse events will be documented at any follow-up evaluations of the present study

  6. Patients' satisfaction [ Time Frame: 12 months ]
    Patients' satisfaction for the treatment received will be registered at the final 12 months evaluation



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ranging from 18 to 55
  • patients affected by knee articular degenerative pathology with history of chronic (for at least 4 months) pain or swelling;
  • imaging findings of degenerative changes of the joint (Kellgren Lawrence 0 to 2 at X-ray evaluation).

Exclusion Criteria:

  • age > 55 years;
  • Kellgren-Lawrence score at X-ray evaluation > 2;
  • major axial deviation (varus >5° , valgus > 5°),
  • systemic disorders such as diabetes, rheumatoid arthritis, haematological diseases (coagulopathy), severe cardiovascular diseases, infections, immunodepression;
  • patients in therapy with anticoagulants or antiaggregants;
  • use of NSAIDs in the 5 days before blood donation;
  • previous intra-articular injections in the past 6 months before blood donation;
  • previous knee surgery in the past 12 months before blood donation;
  • patients with Hb values < 11 g/dl and platelet values < 150,000/mmc

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): NCT02135367


Locations
Italy
II Orthopaedic Clinic, Rizzoli Orthopaedic Institute
Bologna, Emilia Romagna, Italy, 40136
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
Principal Investigator: Alessandro Di Martino, MD II Clinic and Biomechanics Lab,Rizzoli Orthopaedic Institute, Bologna, Italy

Publications:

Responsible Party: Federica Balboni, BScD, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT02135367     History of Changes
Other Study ID Numbers: PRP-KNEE 012
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

Keywords provided by Federica Balboni, Istituto Ortopedico Rizzoli:
PRP
growth factors
Viscosupplementation
injections
chondropathy
randomized controlled trial

Additional relevant MeSH terms:
Osteoarthritis
Cartilage Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases