Total Knee ArthroplastyNCT00958945
Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements
An observational study of Total Knee Arthroplasty and Arthroplasty, Replacement, Hip, run by Desert Orthopedic Center Medical Research Foundation at 1 site in United States.
Trial summary
The purpose of this analysis is to compare Hemoglobin and Hematocrit levels following total hip or knee arthroplasty. The utilization of FloSeal intraoperatively will improve hemostasis postoperatively. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Total Knee Arthroplasty, Arthroplasty, Replacement, Hip
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to not given
- Phase
- Observational
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All Dr. Velyvis's patients that have had a Total Knee or Total Hip after January 1, 2007
Who may be able to join
- Total Knee and Total Hip Patients
- Surgical Time less than 2 hours
Who cannot join
- Patients who require greater than 2 hour surgeries
- Patients who are undergoing revision arthroplasty
- Patients with known allergies to materials of bovine origin
Trial locations and contacts
1 site in 1 country.
United States1 site
Desert Orthopedic Center
Rancho Mirage, California, 92211
About this study
Official title: Retrospective & Prospective Evaluation/Analysis of Hb/Hct in Patients Having Received FloSeal (5ml &10ml) When Undergoing Total Knee or Total Hip Arthroplasty
The purpose of this analysis is to compare Hemoglobin and Hematocrit levels following total hip or knee arthroplasty. The utilization of FloSeal intraoperatively will improve hemostasis postoperatively. Decreasing bleeding time will decrease the drop in level of Hemoglobin and Hematocrit which usually occurs postoperatively.
Read the detailed description
Retrospective Analysis of charts on patients having undergone Total Hip or Total Knee Arthroplasty. During the patient's hospitalization, lab values of Hg and Hct will be recorded for further analysis. Preoperative levels will be also noted to establish baselines.
Primary Data interest will be Hemoglobin (Hgb) level documented during hospitalization along with Hematocrit (HCT) and Red Blood Cell (RBC) data also collected.
Secondary Data gathered will consist of the following:
- patient Demographics
- Component Profile
- Length of Stay
- Anesthesia used
- Anesthesiologist
- EBL
- drain type
- Amount of drainage fluid recorded at 12 hour increments until discharge
- Amount of FloSeal used
- Type of Arthroplasty 500 patients in Total
- 100 Historical Control Patients, knees - no FloSeal (retrospective)
- 100 Patients, knees - 5mL FloSeal (retrospective)
- 100 Patients, knees- 10mL FloSeal (prospective)
- 100 Historical Control patients, hips-no FloSeal (retrospective)
- 100 retrospective patients, hips-5mL of FloSeal (retrospective
Patients scheduled for Total Knee Arthroplasty will be asked if they wish to participate in the part of the study utilizing 10mL of FloSeal. These patient will be consented and the their data will be retrospectively gathered.
- Keywords
- Postoperative Hematocrit, Postoperative Hemoglobin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FloSeal - Knee - control | 100 Historical Control Patients, knees - no FloSeal (retrospective) | |
| FloSeal - Knee - 5ml | 100 Patients, knees - 5mL FloSeal (retrospective) | |
| FloSeal - Knee - 10ml | 100 Patients, knees- 10mL FloSeal (prospective) | |
| FloSeal - Hip - Control | 100 Historical Control patients, hips-no FloSeal (retrospective) | |
| FloSeal - Hip - 5ml | 100 retrospective patients, hips-5mL of FloSeal (retrospective) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Desert Orthopedic Center Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Investigators
- John H. Velyvis,, MD, Principal investigator, Desert Orthopedic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958945
- Sponsor's protocol ID
- FloSeal
- Status last verified
- Aug 2009
- First submitted
- 12 Aug 2009
- Last updated
- 14 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective & Prospective Evaluation/Analysis of Hb/Hct in Patients Having Received FloSeal (5ml &10ml) When Undergoing Total Knee or Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00958945
- Acronym / sponsor ID
- FloSeal
- Keywords
- Postoperative Hematocrit, Postoperative Hemoglobin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Desert Orthopedic Center Medical Research FoundationUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Sep 2009
- First posted
- 14 Aug 2009 (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.
The purpose of this analysis is to compare Hemoglobin and Hematocrit levels following total hip or knee arthroplasty. The utilization of FloSeal intraoperatively will improve hemostasis postoperatively. Decreasing bleeding time will decrease the drop in level of Hemoglobin and Hematocrit which usually occurs postoperatively.
Detailed description
Retrospective Analysis of charts on patients having undergone Total Hip or Total Knee Arthroplasty. During the patient's hospitalization, lab values of Hg and Hct will be recorded for further analysis. Preoperative levels will be also noted to establish baselines.
Primary Data interest will be Hemoglobin (Hgb) level documented during hospitalization along with Hematocrit (HCT) and Red Blood Cell (RBC) data also collected.
Secondary Data gathered will consist of the following:
- patient Demographics
- Component Profile
- Length of Stay
- Anesthesia used
- Anesthesiologist
- EBL
- drain type
- Amount of drainage fluid recorded at 12 hour increments until discharge
- Amount of FloSeal used
- Type of Arthroplasty 500 patients in Total
- 100 Historical Control Patients, knees - no FloSeal (retrospective)
- 100 Patients, knees - 5mL FloSeal (retrospective)
- 100 Patients, knees- 10mL FloSeal (prospective)
- 100 Historical Control patients, hips-no FloSeal (retrospective)
- 100 retrospective patients, hips-5mL of FloSeal (retrospective
Patients scheduled for Total Knee Arthroplasty will be asked if they wish to participate in the part of the study utilizing 10mL of FloSeal. These patient will be consented and the their data will be retrospectively gathered.
Study design
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| FloSeal - Knee - control | – | –100 Historical Control Patients, knees - no FloSeal (retrospective) |
| FloSeal - Knee - 5ml | – | –100 Patients, knees - 5mL FloSeal (retrospective) |
| FloSeal - Knee - 10ml | – | –100 Patients, knees- 10mL FloSeal (prospective) |
| FloSeal - Hip - Control | – | –100 Historical Control patients, hips-no FloSeal (retrospective) |
| FloSeal - Hip - 5ml | – | –100 retrospective patients, hips-5mL of FloSeal (retrospective) |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Dr. Velyvis's patients that have had a Total Knee or Total Hip after January 1, 2007
Key inclusion criteria (2 listed)
- Total Knee and Total Hip Patients
- Surgical Time less than 2 hours
Key exclusion criteria (3 listed)
- Patients who require greater than 2 hour surgeries
- Patients who are undergoing revision arthroplasty
- Patients with known allergies to materials of bovine origin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2009.
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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.
John H. Velyvis,, MD principal investigator
Desert Orthopedic Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty and Arthroplasty, Replacement, Hip, run by Desert Orthopedic Center Medical Research Foundation 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Aug 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles Z Cyr, BA (760-766-1227, ccyr@desertortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 14 Aug 2009.