NCT00167895

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

April 25, 2007

Status Verified

April 1, 2007

First QC Date

September 10, 2005

Last Update Submit

April 24, 2007

Conditions

Osteoarthritis

Keywords

osteoarthritiskneeplatelet concentrate

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (9)

  • Number of homologous blood packed cells needed after TKA

  • Pain score (VAS)

  • Wound complications

  • Amount and sort of analgesics required

  • Outcome scoring systems:

  • +4 more secondary outcomes

Interventions

Adding platelet concentrate to the woundPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing primary total knee arthroplasty for primary osteoarthritis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westfries Gasthuis

Hoorn, 1620AR, Netherlands

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Karin S Peters, MD

    Slotervaart Ziekenhuis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 14, 2005

Study Start

October 1, 2004

Study Completion

December 1, 2006

Last Updated

April 25, 2007

Record last verified: 2007-04

Locations

NL(1)