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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Komzak Martin, M.D., Hospital Znojmo
ClinicalTrials.gov Identifier:
NCT01418755
First received: August 15, 2011
Last updated: September 14, 2011
Last verified: September 2011

August 15, 2011
September 14, 2011
January 2009
November 2009   (final data collection date for primary outcome measure)
Change of the width of cartilage in the knee joint assessed by magnetic resonance imaging before and after nine Platelets Rich Plasma injections. [ Time Frame: 11 months after first Platelets Rich Plasma injection ] [ Designated as safety issue: Yes ]
50 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.
Same as current
Complete list of historical versions of study NCT01418755 on ClinicalTrials.gov Archive Site
Changes in the subjective and objective clinical outcomes before and after nine Platelets Rich Plasma injections. [ Time Frame: 11 months ] [ Designated as safety issue: Yes ]
50 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.
Same as current
Not Provided
Not Provided
 
Study of Platelet-rich Plasma in Treating Patients With Tibiofemoral Cartilage Degeneration
Platelet-rich Plasma in Patients With Tibiofemoral Cartilage Degeneration

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cartilage Degeneration
Biological: 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).
Experimental: 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.
Intervention: Biological: platelet rich plasma injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2011
November 2009   (final data collection date for primary outcome measure)

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.
Both
31 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT01418755
NT12057
Yes
Komzak Martin, M.D., Hospital Znojmo
Komzak Martin, M.D.
Not Provided
Principal Investigator: Radek Hart, prof, M.D. Hospital Znojmo
Hospital Znojmo
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP