Platelet-rich Plasma vs Viscosupplementation in the Treatment of Knee Articular Degenerative Pathology

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01670578
• Date of registration: 13/08/2012
• Prospective Registration: No
• Primary sponsor: Istituto Ortopedico Rizzoli
• Public title: Platelet-rich Plasma vs Viscosupplementation in the Treatment of Knee Articular Degenerative Pathology PRP2009
• Scientific title: Platelet-rich Plasma (PRP) vs Viscosupplementation in the Treatment of Knee Articular Degenerative Pathology: a Randomized Double-blind Controlled Trial
• Date of first enrolment: February 2009
• Target sample size: 192
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01670578
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Italy

Contacts

• Name: Elizaveta Kon, MD
• Affiliation: III Orthopaedic Clinic and Nano-biotechnology Lab, Rizzoli Orthopaedic Institute, Bologna, Italy

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 III 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Knee Chondropathy

Osteoarthritis, Knee

Intervention(s)

Biological: PRP

Device: Hyaluronic acid

Primary Outcome(s)

IKDC (International Knee Documentation Committee) subjective score variation for both groups of treatment at 12 months of follow-up (f-up) [Time Frame: baseline and 12 months of follow-up]

Secondary Outcome(s)

KOOS (Knee injury and Osteoarthritis Outcome Score) variation for both groups of treatment at 2 months of follow-up (f-up) [Time Frame: baseline and 2 months of follow-up]

IKDC (International Knee Documentation Committee) objective score variation for both groups of treatment at 6 months of follow-up (f-up) [Time Frame: baseline and 6 months of follow-up]

Knee Range of Motion variation for both groups of treatment at 6 months of follow-up (f-up) [Time Frame: baseline and 6 months of follow-up]

KOOS (Knee injury and Osteoarthritis Outcome Score) variation for both groups of treatment at 12 months of follow-up (f-up) [Time Frame: baseline and 12 months of follow-up]

Tegner score variation for both groups of treatment at 12 months of follow-up (f-up) [Time Frame: baseline and 12 months of follow-up]

Trend in the concentration of GFs and cytokines in synovial fluid [Time Frame: Baseline, day 7 (second injection), day 14 (third injection)]

Knee Range of Motion (ROM) variation for both groups of treatment at 12 months of follow-up (f-up) [Time Frame: baseline and 12 months of follow-up]

IKDC (International Knee Documentation Committee) objective score variation for both groups of treatment at 2 months of follow-up (f-up) [Time Frame: baseline and 2 months of follow-up]

Knee Trans patellar and distal quadriceps circumference variation for both groups of treatment at 12 months of follow-up (f-up) [Time Frame: baseline and 12 months of follow-up]

IKDC (International Knee Documentation Committee) subjective score variation for both groups of treatment at 6 months of follow-up (f-up) [Time Frame: baseline and 6 months of follow-up]

Knee Trans patellar and distal quadriceps circumference variation for both groups of treatment at 2 months of follow-up (f-up) [Time Frame: baseline and 2 months of follow-up]

Knee Trans patellar and distal quadriceps circumference variation for both groups of treatment at 6 months of follow-up (f-up) [Time Frame: baseline and 6 months of follow-up]

KOOS (Knee injury and Osteoarthritis Outcome Score) variation for both groups of treatment at 6 months of follow-up (f-up) [Time Frame: baseline and 6 months of follow-up]

Number of Participants with Adverse Events [Time Frame: 2, 6, 12 months of follow up]

Pain Level on a Visual Analogue Score after each intra-articular injection [Time Frame: 7 days after each injection]

IKDC (International Knee Documentation Committee) objective score variation for both groups of treatment at 12 months of follow-up (f-up) [Time Frame: baseline and 12 months of follow-up]

VAS (Visual Analogue scale) for General Health Status variation for both groups of treatment at 2 months of follow-up (f-up) [Time Frame: baseline and 2 months of follow-up]

Swelling Level on a Visual Analogue Score after each injection [Time Frame: 7 days after each injection]

Tegner score variation for both groups of treatment at 6 months of follow-up (f-up) [Time Frame: baseline and 6 months of follow-up]

Knee Range of Motion variation for both groups of treatment at 2 months of follow-up (f-up) [Time Frame: baseline and 2 months of follow-up]

Pain Duration after each intra-articular injection [Time Frame: 7 days after each injection]

Patient global satisfaction for the treatment [Time Frame: 12 months]

Trend in the concentration of GFs and cytokines in peripheral blood [Time Frame: Baseline, day 7 (second injection), day 14 (third injection), 2 months, 6 months, 12 months]

VAS (Visual Analogue scale) for General Health Status variation for both groups of treatment at 12 months of follow-up (f-up) [Time Frame: baseline and 12 months of follow-up]

IKDC (International Knee Documentation Committee) subjective score variation for both groups of treatment at 2 months of follow-up (f-up) [Time Frame: baseline and 2 months of follow-up]

Swelling Duration after each injection [Time Frame: 7 days after each injection]

Tegner score variation for both groups of treatment at 2 months of follow-up (f-up) [Time Frame: baseline and 2 months of follow-up]

VAS (Visual Analogue scale) for General Health Status variation for both groups of treatment at 6 months of follow-up (f-up) [Time Frame: baseline and 6 months of follow-up]

Secondary ID(s)

KNEEJECT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors