OsteoarthritisNCT01075230
Standard Total Knee Arthroplasty Using Platelet Rich Plasma (PRP)
A study testing Total knee arthroplasty in people with Osteoarthritis, run by Exactech at 1 site in United States.
Trial summary
Clinical study to determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jan 2013
- Phase
- Interventional
- 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
- 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) month post-operative period although longer follow-up may be 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 PRP in
- 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 has a 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 another medical device, drug, or biologic clinical trial (active defined as having treatment within the last 30 days)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Single-blind, Multi-center Clinical Study to Evaluate the Effect of Platelet Rich Plasma (PRP) on Short-term Patient Outcomes Following Total Knee Replacement.
Clinical study to determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma.
Read the detailed description
The purpose of this study is to determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma.
- Conditions
- Osteoarthritis
- Being tested
- Total knee arthroplasty
- Keywords
- PRP, TKA, pain scale, hemoglobin, hematocrit, narcotics
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
Also called Optetrak total knee system
Subject will undergo total knee arthroplasty according to established surgeon / hospital protocol.
| Study group | Role | What they receive |
|---|---|---|
| Standard TKA | Active comparator | Subjects in this arm will receive total knee replacement as standard of care without Platte Rich Plasma Receives: Procedure: Total knee arthroplasty |
| Standard TKA with PRP | Active comparator | Subjects in this arm will receive total knee replacement as standard of care with Platte Rich Plasma Receives: Procedure: Total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin (Hgb) level
Hemoglobin level analysis
Measured: Preop, post-op day 2
Secondary outcomes (1)
Visual analog scale (VAS) for pain
Visual analog scale for Pain (1-10), 10 being the worst
Measured: Preop, post-op day 1, post-op day 2, discharge, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Intended as multi-center. 1 of 2 sites could not participate. Enrollment discontinued after 50/100. Subjects followed per protocol.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exactech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075230
- Sponsor's protocol ID
- CR08-004
- Status last verified
- Aug 2022
- First submitted
- 23 Feb 2010
- 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
- A Prospective, Randomized, Single-blind, Multi-center Clinical Study to Evaluate the Effect of Platelet Rich Plasma (PRP) on Short-term Patient Outcomes Following Total Knee Replacement.
- ClinicalTrials.gov ID
- NCT01075230
- Acronym / sponsor ID
- CR08-004
- Conditions
- Osteoarthritis
- Keywords
- PRP, TKA, pain scale, hemoglobin, hematocrit, narcotics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Intended as multi-center. 1 of 2 sites could not participate. Enrollment discontinued after 50/100. Subjects followed per protocol.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- ExactechIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 Feb 2010 (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 determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma.
Detailed description
The purpose of this study is to determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard TKA | Active comparator | Procedure: Total knee arthroplastySubjects in this arm will receive total knee replacement as standard of care without Platte Rich Plasma |
| Standard TKA with PRP | Active comparator | Procedure: Total knee arthroplastySubjects in this arm will receive total knee replacement as standard of care with Platte Rich Plasma |
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
- 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) month post-operative period although longer follow-up may be 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 PRP in
- 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 has a 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 |
|---|---|---|
| Total knee arthroplastyAlso: Optetrak total knee systemSubject will undergo total knee arthroplasty according to established surgeon / hospital protocol. | Procedure or surgery | Standard TKA, Standard TKA with PRP |
Primary outcome
Change in hemoglobin (Hgb) level
Time frame: Preop, post-op day 2
Hemoglobin level analysis
1 secondary outcome
Visual analog scale (VAS) for pain
Time frame: Preop, post-op day 1, post-op day 2, discharge, 6 weeks
Results and safety
The study was stopped early (reason given: Intended as multi-center. 1 of 2 sites could not participate. Enrollment discontinued after 50/100. Subjects followed per protocol.). Results are not available in the source record.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty in people with Osteoarthritis, run by Exactech at 1 site 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: stopped early, 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 1 site 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.
Are results available for this study?
The study was stopped early (reason given: Intended as multi-center. 1 of 2 sites could not participate. Enrollment discontinued after 50/100. Subjects followed per protocol.). Results are not available in the source record.
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?
Change in hemoglobin (Hgb) level (time frame: Preop, post-op 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.