Standard Total Knee Arthroplasty Using Platelet Rich Plasma (PRP)
This study is ongoing, but not recruiting participants.
Sponsor:
Exactech
Information provided by (Responsible Party):
Exactech
ClinicalTrials.gov Identifier:
NCT01075230
First received: February 23, 2010
Last updated: January 7, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Osteoarthritis |
Procedure: Total knee arthroplasty |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Exactech:
Primary Outcome Measures:
- Change in hemoglobin (Hgb) level [ Time Frame: Preop, post-op day 2 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Visual analogue scale (VAS) for pain [ Time Frame: Preop, post-op day 1, post-op day 2, discharge, 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Standard TKA |
Procedure: Total knee arthroplasty
Subject will undergo total knee arthroplasty according to established surgeon / hospital protocol.
Other Name: Optetrak total knee system
|
| Active Comparator: Standard TKA with PRP |
Procedure: Total knee arthroplasty
Subject will undergo total knee arthroplasty according to established surgeon / hospital protocol.
Other Name: Optetrak total knee system
|
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
- 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
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 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
- 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)
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Exactech |
| ClinicalTrials.gov Identifier: | NCT01075230 History of Changes |
| Other Study ID Numbers: | CR08-004 |
| Study First Received: | February 23, 2010 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Exactech:
|
PRP, TKA, pain scale, hemoglobin, hematocrit, narcotics |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013