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

Cartilage Degeneration Clinical Trial

Official title:

Platelet-rich Plasma in Patients With Tibiofemoral Cartilage Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418755
• Other study ID #: NT12057
• Status: Completed
• Phase: N/A
• First received: August 15, 2011
• Last updated: September 14, 2011
• Start date: January 2009
• Est. completion date: July 2011

Study information

• Verified date: September 2011
• Source: Hospital Znojmo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2011
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 31 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cartilage Degeneration

Intervention

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).

Locations

Country	Name	City	State
Czech Republic	Hospital Znojmo	Znojmo

Sponsors (1)

Lead Sponsor	Collaborator
Komzak Martin, M.D.

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the width of cartilage in the knee joint assessed by magnetic resonance imaging before and after nine Platelets Rich Plasma injections.	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.	11 months after first Platelets Rich Plasma injection	Yes
Secondary	Changes in the subjective and objective clinical outcomes before and after nine Platelets Rich Plasma injections.	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.	11 months	Yes

External Links

•   web site of Investigator´s institution