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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Adding platelet concentrate to the wound
Sponsored by
Westfries Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoarthritis focused on measuring osteoarthritis, knee, platelet concentrate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Westfries Gasthuis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 10, 2005
Last Updated
April 24, 2007
Sponsor
Westfries Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00167895
Brief Title
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

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Westfries Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
osteoarthritis, knee, platelet concentrate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin S Peters, MD
Organizational Affiliation
Slotervaart Ziekenhuis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westfries Gasthuis
City
Hoorn
ZIP/Postal Code
1620AR
Country
Netherlands

12. IPD Sharing Statement

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

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