The Use of Platelet Derived Growth Factors in Total Knee Arthroplasty, a Randomized Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00167895|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : April 25, 2007
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Procedure: Adding platelet concentrate to the wound||Phase 3|
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 (Clinical Trial)|
|Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||The Use of Platelet Derived Growth Factors in Total Knee Arthroplasty, a Randomized Trial|
|Study Start Date :||October 2004|
|Actual Study Completion Date :||December 2006|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00167895
|Hoorn, Netherlands, 1620AR|
|Principal Investigator:||Karin S Peters, MD||Slotervaart Ziekenhuis|