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The Use of Platelet Derived Growth Factors in Total Knee Arthroplasty, a Randomized Trial

This study has been completed.
Sponsor:
Information provided by:
Westfries Hospital
ClinicalTrials.gov Identifier:
NCT00167895
First received: September 10, 2005
Last updated: April 24, 2007
Last verified: April 2007
  Purpose

The objective of this study is to evaluate the effect of autologous platelet concentrate on blood loss (post-operative decrease of haemoglobin concentration), wound healing complications, range of motion, pain reduction and outcome scores when used in total knee arthroplasty.


Condition Intervention Phase
Osteoarthritis
Procedure: Adding platelet concentrate to the wound
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: The Use of Platelet Derived Growth Factors in Total Knee Arthroplasty, a Randomized Trial

Resource links provided by NLM:


Further study details as provided by Westfries Hospital:

Primary Outcome Measures:
  • Decrease in post-operative blood haemoglobin concentration (as a measure for blood loss)
  • Number of days of wound drainage
  • Duration of hospital stay
  • Range of motion (ROM); flexion-extension using a goniometer

Secondary Outcome Measures:
  • Number of homologous blood packed cells needed after TKA
  • Pain score (VAS)
  • Wound complications
  • Amount and sort of analgesics required
  • Outcome scoring systems:
  • o International Knee Society TKA Score
  • o 12-questionnaire score
  • o SF-36
  • · Patient satisfaction using the Likert-scale

Estimated Enrollment: 100
Study Start Date: October 2004
Study Completion Date: December 2006
Detailed Description:

The short-term functional recovery after a total knee arthroplasty (TKA) is largely dependent on initial wound healing. Haematoma formation may lead to prolonged wound drainage and tissue necrosis1, which can have a negative effect on early range of motion, post-operative pain and length of hospital stay. In addition, studies have suggested that prolonged wound drainage also leads to a higher infection rate.

To decrease haematoma formation, primary soft tissue homeostasis and adequate tissue repair are essential. During the immediate reaction of tissue to injury, haemostasis and inflammation occur. Growth factors, especially PDGF (platelet derived growth factor) and TGF-β (transforming growth factor-beta), play a crucial role in the biochemical cascade at the site of repair. These growth factors are mostly derived from platelets. They act as chemotactic agents for polymorphonuclear leucocytes, macrophages, fibroblasts and lymphocytes. Both factors stimulate angiogenesis and fibroplasia. PDGF also has a role in wound contraction and remodeling. When applying large concentrations of growth factors in a wound, faster tissue repair and homeostasis can be expected, thus leading to less haematoma formation.

Treatment with autologous platelet concentrate involves direct application of concentrated platelets, growth factors and fibrin in the operation wound. A small volume (55-110 ml) of the patient’s own blood is taken to derive a platelet rich gel which can be sprayed directly into the wound.

The objective of this study is to evaluate the effect of autologous platelet concentrate on blood loss (post-operative decrease of haemoglobin concentration), wound healing complications, range of motion, pain reduction and outcome scores when used in total knee arthroplasty.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing primary total knee arthroplasty for primary osteoarthritis

Exclusion Criteria:

  • Coagulation disorder
  • Abnormal pre-operative levels of APTT, PT and/or thrombocytes
  • Homologous blood transfusion last 4 weeks
  • Coagulation disorder
  • Use of anticoagulation medication
  • Use of any iron supplements or erythropoietin at time of operation or during 1 week prior to operation
  • Primary bone tumor or metastatic bone disease
  • Unable or unwilling to participate in follow-up
  • Unable to give informed consent
  • Previous infection in knee
  • Use of corticosteroids at time of operation or during 4 weeks prior to operation
  • Any neuromuscular disorder
  • Active infection or osteomyelitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167895

Locations
Netherlands
Westfries Gasthuis
Hoorn, Netherlands, 1620AR
Sponsors and Collaborators
Westfries Hospital
Investigators
Principal Investigator: Karin S Peters, MD Slotervaart Ziekenhuis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00167895     History of Changes
Other Study ID Numbers: M04-035
Study First Received: September 10, 2005
Last Updated: April 24, 2007
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Westfries Hospital:
osteoarthritis
knee
platelet concentrate

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 24, 2014