OsteoarthritisPhase 4NCT00826098
Platelet Rich Plasma (PRP) in Total Knee Replacement
A Phase 4 study testing Platelet Rich Plasma in people with Osteoarthritis and Inflammatory Arthritis, run by Exactech at 2 sites in United States.
Trial summary
Clinical study to evaluate the effect of platelet rich plasma (PRP), a derivative of a patient's whole blood, on short-term patient outcomes following total knee replacement (TKR). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Inflammatory Arthritis
- What is being tested?
- Platelet Rich Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2008to Feb 2013
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is a male or female who is undergoing primary unilateral surgery or the first surgery of a staged bilateral total knee replacement where the second stage will be at least 6 weeks later PRP in Total Knee.
- Patient agrees to be blinded to their treatment group assignment.
- Patient is willing and able to return for follow-up over at least a six (6) week post-operative period although longer follow-up is desired
- Patient agrees to participate by signing an IRB approved Informed Consent Form
Who cannot join
- Patient will have a staged bilateral total knee replacement with the second stage to be performed less than 6 weeks after the first stage surgery
- Patient has had previous surgery on the operative knee that will necessitate the removal of existing hardware (e.g. previous osteotomy)
- Patient has a known adverse reaction or sensitivity to bovine (cow) thrombin (used as part of the platelet rich plasma system) or other bovine-derived products
- Patient has hemoglobin < 12.0 (males), < 11.0 (females)
- Patient clinically significant anxiety disorder
- Patient is on therapeutic anticoagulation medication and has an INR > 1.3
Show all 12Show fewer
- Patient has a severe bleeding disorder
- Patient has a known addiction to drugs or alcohol, including, but not limited to: chronic daily use of narcotic medications for more than 90 days prior to surgery
- Patient is pregnant
- Patient is a prisoner
- Patient is involved in a personal litigation (e.g. Worker's Compensation) that relates to their knee surgery
- Patient is actively participating in an investigational medical device, drug, or biologic clinical trial (active defined as having treatment within the last 30 days)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Joint Replacement, St. Mary's Regional Medical Center
Lewiston, Maine, 04240
Peninsula Orthopedic Associates
Salisbury, Maryland, 21804
About this study
Official title: Platelet Rich Plasma (PRP) in Total Knee Replacement: A Prospective, Randomized, Single-blind, Single-center Clinical Study to Evaluate the Effect of Platelet Rich Plasma (PRP) on Short-term Patient Outcomes Following Total Knee Replacement
Clinical study to evaluate the effect of platelet rich plasma (PRP), a derivative of a patient's whole blood, on short-term patient outcomes following total knee replacement (TKR).
Read the detailed description
The purpose of this clinical study is to evaluate the effect of platelet rich plasma (PRP), a derivative of a patient's whole blood, on short-term patient outcomes following total knee replacement (TKR). The hypothesis is that change in short-term hemoglobin (Hgb) levels is less dramatic in patients who undergo TKR with the addition of PRP when compared to patients who undergo TKR without PRP.
- Conditions
- Osteoarthritis, Inflammatory Arthritis
- Being tested
- Platelet Rich Plasma
- Keywords
- Total knee replacement, Platelet Rich Plasma, PRP, Biologic, Randomized
- Medical subject headings
- Osteoarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaBiological
Also called Accelerate PRP
Addition of PRP to total knee replacement procedure
| Study group | Role | What they receive |
|---|---|---|
| 1 (PRP) | Experimental | Total knee replacement with PRP Receives: Biological: Platelet Rich Plasma |
| 2 (non-PRP) | No intervention | Total knee replacement without PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin level
Hemoglobin level analysis
Measured: Change in hemoglobin (Hgb) level (preop compared to postop day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionJun 2011
- Study completionFeb 2013
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.
- More trials run by ExactechThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exactech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wayne Moody, MD, Principal investigator, Central Maine Orthopaedics, PAPasquale Petrera, MD, Principal investigator, Peninsula Orthopedic Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826098
- Sponsor's protocol ID
- CR07-004
- Status last verified
- Aug 2022
- First submitted
- 20 Jan 2009
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Plasma (PRP) in Total Knee Replacement: A Prospective, Randomized, Single-blind, Single-center Clinical Study to Evaluate the Effect of Platelet Rich Plasma (PRP) on Short-term Patient Outcomes Following Total Knee Replacement
- ClinicalTrials.gov ID
- NCT00826098
- Acronym / sponsor ID
- CR07-004
- Conditions
- Osteoarthritis, Inflammatory Arthritis
- Keywords
- Total knee replacement, Platelet Rich Plasma, PRP, Biologic, Randomized
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- ExactechIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 21 Jan 2009 (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.
Clinical study to evaluate the effect of platelet rich plasma (PRP), a derivative of a patient's whole blood, on short-term patient outcomes following total knee replacement (TKR).
Detailed description
The purpose of this clinical study is to evaluate the effect of platelet rich plasma (PRP), a derivative of a patient's whole blood, on short-term patient outcomes following total knee replacement (TKR). The hypothesis is that change in short-term hemoglobin (Hgb) levels is less dramatic in patients who undergo TKR with the addition of PRP when compared to patients who undergo TKR without PRP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 (PRP) | Experimental | Biological: Platelet Rich PlasmaTotal knee replacement with PRP |
| 2 (non-PRP) | No intervention | –Total knee replacement without PRP |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is a male or female who is undergoing primary unilateral surgery or the first surgery of a staged bilateral total knee replacement where the second stage will be at least 6 weeks later PRP in Total Knee.
- Patient agrees to be blinded to their treatment group assignment.
- Patient is willing and able to return for follow-up over at least a six (6) week post-operative period although longer follow-up is desired
- Patient agrees to participate by signing an IRB approved Informed Consent Form
Key exclusion criteria (12 listed)
- Patient will have a staged bilateral total knee replacement with the second stage to be performed less than 6 weeks after the first stage surgery
- Patient has had previous surgery on the operative knee that will necessitate the removal of existing hardware (e.g. previous osteotomy)
- Patient has a known adverse reaction or sensitivity to bovine (cow) thrombin (used as part of the platelet rich plasma system) or other bovine-derived products
- Patient has hemoglobin < 12.0 (males), < 11.0 (females)
- Patient clinically significant anxiety disorder
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 |
|---|---|---|
| Platelet Rich PlasmaAlso: Accelerate PRPAddition of PRP to total knee replacement procedure | Biological | 1 (PRP) |
Primary outcome
Hemoglobin level
Time frame: Change in hemoglobin (Hgb) level (preop compared to postop day 2)
Hemoglobin level analysis
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 1 Sep 2022.
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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.
Wayne Moody, MD principal investigator
Central Maine Orthopaedics, PA
Pasquale Petrera, MD principal investigator
Peninsula Orthopedic Associates
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Platelet Rich Plasma in people with Osteoarthritis and Inflammatory Arthritis, run by Exactech at 2 sites in United States.
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 4 inclusion and 12 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 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Hemoglobin level (time frame: Change in hemoglobin (Hgb) level (preop compared to postop day 2)). 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 1 Sep 2022.