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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Platelet-rich Plasma (PRP) vs Viscosupplementation for the Treatment of Early Knee Articular Degenerative Pathology: a Randomized Double-blind Controlled Trial

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 (H

Detailed Summary:

Current research is investigating new methods for stimulating repair or replacing damaged cartilage. In particular, the most recent knowledge regarding tissue biology highlights a complex regulation of growth factors (GFs) for the normal tissue structure and the reaction to tissue damage. The influence of GFs on cartilage repair is now widely investigated in vitro and in vivo. Platelet Rich Plasma (PRP) is a simple, low- cost and minimally- invasive method that allows one to obtain a natural concentrate of autologous GFs from the blood, and it is increasingly applied in the clinical practice to treat knee degenerative pathology, such as chondropathy and early OA. The biological rational of PRP is that platelets contain storage pools of GFs, cytokines, chemokines and many other mediators.Although its widespread application, there are no high level studies in the literature to demonstrate the real efficacy of PRP. In fact, at the present moment, to our knowledge there is no published randomized controlled trial comparing PRP with other conservative treatments commonly used for knee OA.

The investigators hypothesized that intra-articular injections of 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 di
Sponsor: Istituto Ortopedico Rizzoli

Current Primary Outcome: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Istituto Ortopedico Rizzoli

Dates:
Date Received: May 7, 2014
Date Started: January 2013
Date Completion: December 2016
Last Updated: December 2, 2015
Last Verified: December 2015