Study of Platelet-rich Plasma in Treating Patients With Tibiofemoral Cartilage Degeneration
|ClinicalTrials.gov Identifier: NCT01418755|
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : September 15, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cartilage Degeneration||Biological: platelet rich plasma injection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Platelet-rich Plasma in Patients With Tibiofemoral Cartilage Degeneration|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||July 2011|
Experimental: platelet rich plasma injection
Fifty consecutive and strictly selected patients, affected by Grade II or III chondromalacia, underwent one year treatment (9 injections) with autologous PRP in a liquid form with 2,0 to 2,5-fold platelets concentration. Outcome measures included the Lysholm, Tegner, IKDC, and Cincinnati scores. Magnetic resonance imaging was used to evaluate cartilage thickness and degree of degeneration.
Biological: platelet rich plasma injection
The approximate 2.0 to 2.5-fold platelet concentration (taking into consideration the mean human blood platelet count of 200 000 /μl) was achieved in all specimens. Mean platelet concentration in PRP was 459 000 /μl (range, 407 000 /μl to 513 000 /μl).
- Change of the width of cartilage in the knee joint assessed by magnetic resonance imaging before and after nine Platelets Rich Plasma injections. [ Time Frame: 11 months after first Platelets Rich Plasma injection ]50 patients with Grade II or III chondromalatia in the knee joint, underwent one year treatment with autologous Platelets Rich Plasma. Magnetic resonance imaging was used to evaluate cartilage thickness and degree of degeneration before and after the treatement of nine Platelets Rich Plasma injection.
- Changes in the subjective and objective clinical outcomes before and after nine Platelets Rich Plasma injections. [ Time Frame: 11 months ]50 patients with Grade II or III chondromalatia in the knee joint, underwent one year treatment with autologous Platelets Rich Plasma. To carefully assess the subjective and objective clinical outcomes, these questionnaires were used: Lysholm score, Tegner activity score, IKDC scores, and Cincinnati score. All these scores were recompleted 11 months after the beginning of the Platelets Rich Plasma injections.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418755
|Znojmo, Czech Republic, 66902|
|Principal Investigator:||Radek Hart, prof, M.D.||Hospital Znojmo|