NCT01418755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
Last Updated

September 15, 2011

Status Verified

September 1, 2011

Enrollment Period

10 months

First QC Date

August 15, 2011

Last Update Submit

September 14, 2011

Conditions

Cartilage Degeneration

Keywords

Platelet-Rich PlasmaKneeTibiofemoral ChondromalaciaInjection

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Changes in the subjective and objective clinical outcomes before and after nine Platelets Rich Plasma injections.

    11 months

Study Arms (1)

platelet rich plasma injection

EXPERIMENTAL

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.

Biological: platelet rich plasma injection

Interventions

platelet rich plasma injectionBIOLOGICAL

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).

platelet rich plasma injection

Eligibility Criteria

Age31 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • isolated Grade II or Grade III nontraumatic chondromalacia according to Outerbridge grading scale

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Znojmo

Znojmo, 66902, Czechia

Location

Related Links

Study Officials

  • Radek Hart, prof, M.D.

    Hospital Znojmo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Hart Radek, M.D., Ph.D., FRS, prof.; Orthopaedic- Traumatologic department

Study Record Dates

First Submitted

August 15, 2011

First Posted

August 17, 2011

Study Start

January 1, 2009

Primary Completion

November 1, 2009

Study Completion

July 1, 2011

Last Updated

September 15, 2011

Record last verified: 2011-09

Locations

CZ(1)