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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00167895
• Other study ID #: M04-035
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2005
• Last updated: April 24, 2007
• Start date: October 2004
• Est. completion date: December 2006

Study information

• Verified date: April 2007
• Source: Westfries Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Adding platelet concentrate to the wound

Locations

Country	Name	City	State
Netherlands	Westfries Gasthuis	Hoorn

Sponsors (1)

Lead Sponsor	Collaborator
Westfries Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in post-operative blood haemoglobin concentration (as a measure for blood loss)
Primary	Number of days of wound drainage
Primary	Duration of hospital stay
Primary	Range of motion (ROM); flexion-extension using a goniometer
Secondary	Number of homologous blood packed cells needed after TKA
Secondary	Pain score (VAS)
Secondary	Wound complications
Secondary	Amount and sort of analgesics required
Secondary	Outcome scoring systems:
Secondary	o International Knee Society TKA Score
Secondary	o 12-questionnaire score
Secondary	o SF-36
Secondary	· Patient satisfaction using the Likert-scale