Clinical trial NCT01418755: Study of Platelet-rich Plasma in Treating Patients With Tibiofemoral Cartilage Degeneration
Official title: Platelet-rich Plasma in Patients With Tibiofemoral Cartilage Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cartilage Degeneration
Keywords: Platelet-Rich Plasma
Knee
Tibiofemoral Chondromalacia
Injection
Lead sponsor: Hospital Znojmo
Sponsor class: OTHER
First posted: 2011-08-17
Enrollment: 50
Sex: ALL
Minimum age (years): 31
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility 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.

Primary outcomes:
measure: Change of the width of cartilage in the knee joint assessed by magnetic resonance imaging before and after nine Platelets Rich Plasma injections.
timeFrame: 11 months after first Platelets Rich Plasma injection
Secondary outcomes:
measure: Changes in the subjective and objective clinical outcomes before and after nine Platelets Rich Plasma injections.
timeFrame: 11 months
Other outcomes:
Locations:
city: Znojmo
country: Czech Republic
facility: Hospital Znojmo
Study officials:
affiliation: Hospital Znojmo
name: Radek Hart, prof, M.D.
role: PRINCIPAL_INVESTIGATOR
References: