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Completed

NCT Number: NCT00167895

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Westfries Gasthuis

Hoorn, 1620AR, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adding platelet concentrate to the wound

Procedure

Primary outcomes

  1. Decrease in post-operative blood haemoglobin concentration (as a measure for blood loss)

  2. Number of days of wound drainage

  3. Duration of hospital stay

  4. Range of motion (ROM); flexion-extension using a goniometer

Secondary outcomes

  1. Number of homologous blood packed cells needed after TKA

  2. Pain score (VAS)

  3. Wound complications

  4. Amount and sort of analgesics required

  5. Outcome scoring systems:

  6. o International Knee Society TKA Score

  7. o 12-questionnaire score

  8. o SF-36

  9. · Patient satisfaction using the Likert-scale

Sponsors and collaborators

Lead sponsor

Westfries Hospital

Other

Registry information

Important dates

Study start
2004
Study completion
2006
First posted
Sep 14, 2005
Registry last updated
Apr 25, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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