Platelet Rich Plasma (PRP) in Total Knee Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2013-02-28

Brief Summary

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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).

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Detailed Description

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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

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Osteoarthritis Inflammatory Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1 (PRP)

Total knee replacement with PRP

Group Type EXPERIMENTAL

Platelet Rich Plasma

Intervention Type BIOLOGICAL

Addition of PRP to total knee replacement procedure

2 (non-PRP)

Total knee replacement without PRP

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Platelet Rich Plasma

Addition of PRP to total knee replacement procedure

Intervention Type BIOLOGICAL

Other Intervention Names

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Accelerate PRP

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Patient agrees to be blinded to their treatment group assignment.
3. 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
4. Patient agrees to participate by signing an IRB approved Informed Consent Form

Exclusion Criteria

1. 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
2. Patient has had previous surgery on the operative knee that will necessitate the removal of existing hardware (e.g. previous osteotomy)
3. 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
4. Patient has hemoglobin \< 12.0 (males), \< 11.0 (females)
5. Patient clinically significant anxiety disorder
6. Patient is on therapeutic anticoagulation medication and has an INR \> 1.3
7. Patient has a severe bleeding disorder
8. 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
9. Patient is pregnant
10. Patient is a prisoner
11. Patient is involved in a personal litigation (e.g. Worker's Compensation) that relates to their knee surgery
12. Patient is actively participating in an investigational medical device, drug, or biologic clinical trial (active defined as having treatment within the last 30 days)

Eligible Sex

ALL

Accepts Healthy Volunteers

No