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

NCT ID: NCT01418755

Last Updated: 2011-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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Cartilage Degeneration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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platelet rich plasma injection

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.

Group Type EXPERIMENTAL

platelet rich plasma injection

Intervention Type BIOLOGICAL

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).

Interventions

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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).

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

31 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Komzak Martin, M.D.

OTHER

Sponsor Role lead

Responsible Party

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Komzak Martin, M.D.

Hart Radek, M.D., Ph.D., FRS, prof.; Orthopaedic- Traumatologic department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Radek Hart, prof, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital Znojmo

Locations

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Hospital Znojmo

Znojmo, , Czechia

Site Status

Countries

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Czechia

Related Links

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http://nemzn.cz

web site of Investigator´s institution

Other Identifiers

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NT12057

Identifier Type: -

Identifier Source: org_study_id

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