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Sponsored by: |
Exactech |
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Information provided by: | Exactech |
ClinicalTrials.gov Identifier: | NCT00826098 |
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 |
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Osteoarthritis Inflammatory Arthritis |
Biological: Platelet Rich Plasma |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy 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 |
Estimated Enrollment: | 170 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 (PRP): Experimental
Total knee replacement with PRP
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Biological: Platelet Rich Plasma
Addition of PRP to total knee replacement procedure
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2 (non-PRP): No Intervention
Total knee replacement without PRP
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Matthew Christensen | 352-376-7783 ext 181 | matt.christensen@exac.com |
United States, Maine | |
Central Maine Orthopaedics, PA | Recruiting |
Auburn, Maine, United States, 04210 | |
Contact: Kristina Chadwick, PA-C 207-783-1328 | |
Contact: Wayne Moody, MD 207-783-1328 | |
Principal Investigator: Wayne Moody, MD | |
United States, Maryland | |
Peninsula Orthopedic Associates | Recruiting |
Salisbury, Maryland, United States, 21804 | |
Contact: Lori Short, RN, BSN 410-543-7530 ext 5465 | |
Contact: Pasquale Petrera, MD 410-749-4154 | |
Principal Investigator: Pasquale Petrera, MD |
Principal Investigator: | Wayne Moody, MD | Central Maine Orthopaedics, PA |
Study Director: | Matthew Christensen | Exactech, Inc. |
Principal Investigator: | Pasquale Petrera, MD | Peninsula Orthopedic Associates |
Responsible Party: | Exactech, Inc. ( Matthew Christensen ) |
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: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00826098 History of Changes |
Health Authority: | United States: Institutional Review Board |
Total knee replacement Platelet Rich Plasma PRP Biologic Randomized |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |