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

Platelet-rich Plasma in Patients With Tibiofemoral Cartilage Degeneration

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01418755
Enrollment
50
Registered
2011-08-17
Start date
2009-01-31
Completion date
2011-07-31
Last updated
2011-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cartilage Degeneration

Keywords

Platelet-Rich Plasma, Knee, Tibiofemoral Chondromalacia, Injection

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.

Interventions

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).

Sponsors

Komzak Martin, M.D.
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
31 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of the width of cartilage in the knee joint assessed by magnetic resonance imaging before and after nine Platelets Rich Plasma injections.11 months after first Platelets Rich Plasma injection50 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.

Secondary

MeasureTime frameDescription
Changes in the subjective and objective clinical outcomes before and after nine Platelets Rich Plasma injections.11 months50 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.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026