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

April 24, 2007 updated by: Westfries Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Hoorn, Netherlands, 1620AR
        • Westfries Gasthuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Westfries Hospital

Investigators

  • Principal Investigator: Karin S Peters, MD, Slotervaart Ziekenhuis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 10, 2005

First Submitted That Met QC Criteria

September 10, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

April 25, 2007

Last Update Submitted That Met QC Criteria

April 24, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M04-035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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