Clinical trial NCT00167895: The Use of Platelet Derived Growth Factors in Total Knee Arthroplasty, a Randomized Trial
Official title: The Use of Platelet Derived Growth Factors in Total Knee Arthroplasty, a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: osteoarthritis
knee
platelet concentrate
Lead sponsor: Westfries Hospital
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: Decrease in post-operative blood haemoglobin concentration (as a measure for blood loss)
measure: Number of days of wound drainage
measure: Duration of hospital stay
measure: Range of motion (ROM); flexion-extension using a goniometer
Secondary outcomes:
measure: Number of homologous blood packed cells needed after TKA
measure: Pain score (VAS)
measure: Wound complications
measure: Amount and sort of analgesics required
measure: Outcome scoring systems:
measure: o International Knee Society TKA Score
measure: o 12-questionnaire score
measure: o SF-36
measure: · Patient satisfaction using the Likert-scale
Other outcomes:
Locations:
city: Hoorn
country: Netherlands
facility: Westfries Gasthuis
Study officials:
affiliation: Slotervaart Ziekenhuis
name: Karin S Peters, MD
role: PRINCIPAL_INVESTIGATOR
References: