Platelet Rich Plasma (PRP) in Total Knee Replacement
This study is ongoing, but not recruiting participants.
Sponsor:
Exactech
Information provided by (Responsible Party):
Exactech
ClinicalTrials.gov Identifier:
NCT00826098
First received: January 20, 2009
Last updated: January 11, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis Inflammatory Arthritis |
Biological: Platelet Rich Plasma |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Exactech:
Primary Outcome Measures:
- Hemoglobin level [ Time Frame: Preop, postop days 1 through discharge, 6 weeks, 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 170 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | January 2013 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1 (PRP)
Total knee replacement with PRP
|
Biological: Platelet Rich Plasma
Addition of PRP to total knee replacement procedure
Other Name: Accelerate PRP
|
|
No Intervention: 2 (non-PRP)
Total knee replacement without PRP
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826098
Locations
| United States, Maine | |
| Center for Joint Replacement, St. Mary's Regional Medical Center | |
| Lewiston, Maine, United States, 04240 | |
| United States, Maryland | |
| Peninsula Orthopedic Associates | |
| Salisbury, Maryland, United States, 21804 | |
Sponsors and Collaborators
Exactech
Investigators
| Principal Investigator: | Wayne Moody, MD | Central Maine Orthopaedics, PA |
| Study Director: | Caitlyn Seidl, BS, CCRP | Exactech, Inc. |
| Principal Investigator: | Pasquale Petrera, MD | Peninsula Orthopedic Associates |
More Information
No publications provided
| Responsible Party: | Exactech |
| ClinicalTrials.gov Identifier: | NCT00826098 History of Changes |
| Other Study ID Numbers: | CR07-004, V. March 26, 2008 (1 site), V. January 8, 2009 (1 site) |
| Study First Received: | January 20, 2009 |
| Last Updated: | January 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Exactech:
|
Total knee replacement Platelet Rich Plasma PRP Biologic Randomized |
Additional relevant MeSH terms:
|
Arthritis Osteoarthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013