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Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial (PRP014)

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ClinicalTrials.gov Identifier: NCT02923700
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Federica Balboni, Istituto Ortopedico Rizzoli

Brief Summary:

Platelet-rich Plasma (PRP) is the most exploited biologic agents currently used for the treatment of osteoarthritis (OA) of different joints, in particular knee OA.

In previous studies, it has been showed its potential to reduce pain and improve functional status in patients treated by simple intra-articular injections. However, there are several PRP formulation currently available in clinical use, and therefore it is very difficult to compare data coming from trials using different products. The most debated aspect concerning PRP formulation is the role of leukocytes, which might stimulate an early inflammatory response in the joint due to the release of metalloproteases and other pro-inflammatory cytokines.

The investigators hypothesized that the presence of leukocytes in PRP could be clinically relevant in terms of outcome, so the present double blind randomized controlled trial was designed to compare leukocyte-rich and leukocyte-poor PRP injections for the treatment of knee OA.

A power analysis has been performed for the primary endpoint of IKDC (International Knee Documentation Committee) 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 leukocyte-rich PRP, whereas the second group of patients will be treated by three intra-articular injections of leukocyte-poor PRP.

PRP will be obtained with the following procedure: a 300-ml autologous venous blood sample will undergo 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 leukocyte-rich PRP. In case of patients allocated to receive leukocyte-poor PRP, a special filter will be then used to separate leukocytes and obtain leukocyte-poor PRP.

The total amount of PRP will be 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.

One week after the PRP production, the injective treatment starts, with 3 weekly injections. 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
Osteoarthritis Biological: Leukocyte-rich PRP intra-articular injections Biological: Leukocyte-poor PRP intra-articular injections Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial
Study Start Date : September 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Leukocyte-rich PRP group
Three weekly knee intra-articular injections of leukocyte-rich PRP
Biological: Leukocyte-rich PRP intra-articular injections
Experimental: Leukocyte-poor PRP group
Three weekly knee intra-articular injections of leukocyte-poor PRP
Biological: Leukocyte-poor PRP intra-articular injections



Primary Outcome Measures :
  1. IKDC (International knee documentation committee) score trend over time [ Time Frame: basal (i.e. pre-treatment), 1 month, 2 months, 6 months and 12 months after treatment ]

Secondary Outcome Measures :
  1. KOOS (Knee Outcome Osteoarthritis Score) trend over time [ Time Frame: basal (i.e. pre-treatment), 1 month, 2 months, 6 months and 12 months after treatment ]
  2. VAS (Visual Analogue Scale) for Pain trend over time [ Time Frame: basal (i.e. pre-treatment), 1 month, 2 months, 6 months and 12 months after treatment ]
  3. Tegner Score trend over time [ Time Frame: basal (i.e. pre-treatment), 1 month, 2 months, 6 months and 12 months after treatment ]
  4. Adverse events report during follow-up period [ Time Frame: ba1 month, 2 months, 6 months and 12 months after treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patients affected by mono-lateral symptomatic knee articular degenerative pathology with history of chronic (for at least 4 months) pain or swelling;
  2. imaging findings of degenerative changes of the joint (osteoarthritis or chondropathy with Kellgren Lawrence Score from 0 to 3 at X-ray evaluation).

Exclusion Criteria:

  • age > 80 years;
  • Kellgren-Lawrence score at X-ray evaluation > 3;
  • 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;
  • 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): NCT02923700


Contacts
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Contact: Elizaveta Kon, MD +39 0516366567 e.kon@biomec.ior.it
Contact: Giuseppe Filardo, MD +39 0516366567 g.filardo@ior.it

Locations
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Italy
Rizzoli Orthopaedic Institute Recruiting
Bologna, Emilia Romagna, Italy, 40136
Contact: Elizaveta Kon, MD    +39 0516366567    e.kon@biomec.ior.it   
Contact: Giuseppe Filardo, MD    +39 0516366567    g.filardo@ior.it   
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
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Study Chair: Berardo Di Matteo, MD I Clinic, Rizzoli Orthopaedic Institute, Bologna, Italy
Study Chair: Alessandro Di Martino, MD I Clinic, Rizzoli Orthopaedic Institute, Bologna, Italy
Study Chair: Francesco Tentoni, MD I Clinic, Rizzoli Orthopaedic Institute, Bologna, Italy
Study Chair: Alice Roffi, BA Rizzoli Orthopaedic Institute, Bologna, Italy
Principal Investigator: Elizaveta Kon, MD I Clinic, Rizzoli Orthopaedic Institute, Bologna, Italy

Publications:

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Responsible Party: Federica Balboni, BScD, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT02923700    
Other Study ID Numbers: PRP014
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Federica Balboni, Istituto Ortopedico Rizzoli:
platelet rich plasma
intra-articular injection
leukocytes
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases