Status:
COMPLETED
Study of Platelet-rich Plasma in Treating Patients With Tibiofemoral Cartilage Degeneration
Lead Sponsor:
Komzak Martin, M.D.
Conditions:
Cartilage Degeneration
Eligibility:
All Genders
31-75 years
Phase:
NA
Brief Summary
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 growt...
Detailed Description
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 plat...
Eligibility Criteria
Inclusion
- isolated Grade II or Grade III nontraumatic chondromalacia according to Outerbridge grading scale
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01418755
Start Date
January 1 2009
End Date
July 1 2011
Last Update
September 15 2011
Active Locations (1)
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1
Hospital Znojmo
Znojmo, Czechia, 66902