OsteoarthritisPhase 3NCT00167895
The Use of Platelet Derived Growth Factors in Total Knee Arthroplasty, a Randomized Trial
A Phase 3 study testing Adding platelet concentrate to the wound in people with Osteoarthritis, run by Westfries Hospital at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Adding platelet concentrate to the wound
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2004to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary total knee arthroplasty for primary osteoarthritis
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Adding platelet concentrate to the wound
- Keywords
- osteoarthritis, knee, platelet concentrate
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adding platelet concentrate to the woundProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
o International Knee Society TKA Score
o 12-questionnaire score
o SF-36
· Patient satisfaction using the Likert-scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startOct 2004
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Westfries Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Karin S Peters, MD, Principal investigator, Slotervaart Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167895
- Sponsor's protocol ID
- M04-035
- Status last verified
- Apr 2007
- First submitted
- 10 Sep 2005
- Last updated
- 25 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Platelet Derived Growth Factors in Total Knee Arthroplasty, a Randomized Trial
- ClinicalTrials.gov ID
- NCT00167895
- Acronym / sponsor ID
- M04-035
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, knee, platelet concentrate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Westfries HospitalUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- Dec 2006 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing primary total knee arthroplasty for primary osteoarthritis
Key exclusion criteria (13 listed)
- Coagulation disorder
- Abnormal pre-operative levels of APTT, PT and/or thrombocytes
- Homologous blood transfusion last 4 weeks
- Coagulation disorder
- Use of anticoagulation medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adding platelet concentrate to the wound | Procedure or surgery | – |
Primary outcome
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
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin S Peters, MD principal investigator
Slotervaart Ziekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adding platelet concentrate to the wound in people with Osteoarthritis, run by Westfries Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in post-operative blood haemoglobin concentration (as a measure for blood loss). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2007.