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

Komzak Martin, M.D.

Status: Completed

Conditions: Cartilage Degeneration

Treatments: Biological: platelet rich plasma injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01418755

NT12057

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 50 patients

Sex: All

Ages: 31 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

platelet rich plasma injection

Experimental group

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 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.

Treatment:

Biological: platelet rich plasma injection