Trial | NCT01418755  Report issue

Title

Study of Platelet-rich Plasma in Treating Patients With Tibiofemoral Cartilage Degeneration
Platelet-rich Plasma in Patients With Tibiofemoral Cartilage Degeneration

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    50
Recently an articular cartilage repair has been given much attention in the orthopaedic field. Cartilage regeneration capacity is very limited. Optimal approach seems to be a delivery of natural growth factors. Autologous platelet-rich plasma (PRP) contains proliferative and chemoattractant growth factors. The objective of the present study was to determine if PRP can increase tibiofemoral cartilage regeneration and improve knee function.
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 hte Lysholm, Tegner, IKDC, and Cincinnati scores. Magnetic resonance imaging was used to evaluate cartilage thickness and degree of degeneration.
Study Started
Jan 31
2009
Primary Completion
Nov 30
2009
Study Completion
Jul 31
2011
Last Update
Sep 15
2011
Estimate

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).

platelet rich plasma injection Experimental

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.

Criteria 

Inclusion Criteria:

isolated Grade II or Grade III nontraumatic chondromalacia according to Outerbridge grading scale

Exclusion Criteria:

Grade I (only softening) or Grade IV (exposed subchondral bone) tibiofemoral chondromalacia;
patellofemoral chondral damage;
associated intraarticular lesions confirmed during arthroscopy (menisci, ligaments, osteochondral defects);
associated extraarticular lesions confirmed by magnetic resonance imaging (ligaments, tendons, bursae);
lower limb axial deviation confirmed by whole leg weight-bearing radiograph; knee trauma in patients history;
body mass index (BMI) higher than 35;
hyaluronic acid intraarticular injection 6 months prior the arthroscopy and up to last follow-up control;
steroids intraarticular injection 3 months prior the arthroscopy and up to last follow-up control;
symptomatic slow acting drugs for osteoarthritis (SYSADOA) and/or non-steroidal anti-inflammatory drugs (NSAID) administration during the PRP treatment;
systemic autoimmune rheumatic and/or polyarticular disease; gout, pseudogout and hyperuricaemia.
Other exclusion criteria included: non-informed consent; treated knee injury during the PRP therapy; PRP injection cycle not completed; impediments to fill out the questionnaires; blood disease and/or immunosuppressant treatment and/or dicoumarol therapy; immunosuppressant and/or neoplastic and/or infectious diseases.
No Results Posted