Knee Replacement SurgeryPhase 4NCT01410240
Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty
A Phase 4 study of Knee Replacement Surgery and Osteoarthritis, run by Baxter Healthcare Corporation at 12 sites in United States.
Trial summary
The purpose of this study is to compare the efficacy and safety of FLOSEAL to standard of care for hemostasis in subjects undergoing total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Replacement Surgery, Osteoarthritis
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 12 sitesUnited States
- Study dates
- Sep 2011to Jan 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is 18 to 80 years of age inclusive at the time of screening
- Participant is planned for primary unilateral total knee arthroplasty
- Participant has signed the informed consent form
- Participant is in stable health (i.e., able to undergo surgery and participate in a follow-up program based on physical examination and medical history)
- Participant has a preoperative Hgb level > 10 g/dL
- If female of childbearing potential, the participant presents with a negative urine pregnancy test and agrees to employ adequate birth control measures for the duration of the study
- Participant is willing and able to comply with the requirements of the protocol
Who cannot join
- Participant has had a previous total or partial knee arthroplasty or any surgery on the knee within the previous 6 months
- Participant has osteonecrosis or arthrotomy within the last year
- Participant has prior or current hardware in target knee
- Participant has had injections in the knee:
- Steroids within the 3 months prior to scheduled surgery,
- Synvisc, Hyalin, etc. within the 6 months prior to scheduled surgery
Show all 21Show fewer
- Participant has had general surgery within 3 months
- Participant has rheumatoid arthritis or any other inflammatory or traumatic bone injuries to the knee within the 12 months prior to scheduled surgery
- Participant has allergies to products of bovine origin
- Participant has a history of bleeding, platelet, or bone marrow disorders
- Participant has donated more than 1 unit of blood donation in the 3 weeks prior to surgery
- Participant has a history of a coagulation disorder
- Participant is currently taking dipyridamole/ASA (Aggrenox) and/or enoxaparin (Lovenox)
- Participant has been treated with aspirin or Warfarin (Coumadin) or clopidogrel (Plavix) within 7 days prior to surgery
- Participant is not permitted to remain without his/her anti-coagulant regimen (e.g. Plavix) for 48 hours postoperatively
- Participant has taken nonsteroidal anti-inflammatory agents or herbal supplements within 7 days of surgery
- Participant has a history of substance abuse (alcohol, drugs) or is an active smoker
- Participant has liver cirrhosis
- Participant has erythropoietin agonist/stimulating agent within 90 days prior to surgery
- Participant has an active infection or previous history of infection in the affected joint within the previous 6 months
- Participant has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP or device during the course of this study
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Hill Country Clinical Research, Inc.
Austin, Texas, 78759
Florida Research Associates, LLC
DeLand, Florida, 32720
Rothman Institute
Egg Harbor, New Jersey, 08234-5500
Colorado Orthopedic Consultants, PC
Englewood, Colorado, 80110
Shrock Orthopedic Research, LLC
Fort Lauderdale, Florida, 33316
Cedars-Sinai Orthopedic Center
Los Angeles, California, 90042
Joint Replacement Surgeons of Indiana Foundations
Mooresville, Indiana, 46158
The Rothman Institute, Philadelphia
Philadelphia, Pennsylvania, 19107
Temple University
Philadelphia, Pennsylvania, 19140
Stanford Orthopedics
Redwood City, California, 94063
Phoenix Clinical Research, LLC
Tamarac, Florida, 33321
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: A Prospective, Randomized, Controlled, Single-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of FLOSEAL for Hemostasis in Primary Unilateral Total Knee Arthroplasty (TKA)
The purpose of this study is to compare the efficacy and safety of FLOSEAL to standard of care for hemostasis in subjects undergoing total knee arthroplasty.
- Conditions
- Knee Replacement Surgery, Osteoarthritis
- Being tested
- Standard of Care, FLOSEAL Hemostatic Matrix + Standard of care
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareProcedure or surgery
Conventional hemostatic techniques, such as cautery and manual compression, will be used.
FLOSEAL Hemostatic Matrix + Standard of careDrug
Also called FLOSEAL
FLOSEAL will be applied topically to areas of the knee where bleeding is observed (e.g. cut bone surfaces, subcutaneous tissue, posterior joint capsule, synovial tissue, medial and lateral gutters, branches of the genicular vessels, and suprapatellar pouch) and will occur intraoperatively. Sufficient amounts of FLOSEAL will be applied quickly using the provided applicators, followed by immediate approximation with a damp gauze, lap pad or sponge for approximately 2 minutes.
+ Standard of care: conventional hemostatic techniques, such as cautery and manual compression, will be used
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SoC) | Active comparator | SoC: conventional hemostatic techniques such as cautery and manual compression Receives: Procedure: Standard of Care |
| FLOSEAL + Standard of Care (SoC) | Experimental | FLOSEAL: consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression Receives: Drug: FLOSEAL Hemostatic Matrix + Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively
Measured: Pre-operative and 2 days post-operatively
Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP)
- Proportion of Participants who have serious injuries (SIs) related to IP
- Proportion of Participants who have non-serious adverse events (non-SAEs) related to IP
Measured: Throughout the study period, 1 year and 4 months
Secondary outcomes (32)
Change in Hemoglobin (Hgb) Levels at Day 1 Post-operatively
Measured: Pre-operative and day 1 post-operatively
Change in Hemoglobin (Hgb) Levels at Day 3 Post-operatively
Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels.
Measured: Pre-operative and day 3 post-operatively
Change From Baseline in Hematocrit (Hct) at Postoperative Day 1
Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels.
Measured: Pre-operative and day 1 post-operatively
Change From Baseline in Hematocrit (Hct) at Postoperative Day 2
Measured: Pre-operative and day 2 post-operatively
Change From Baseline in Hematocrit (Hct) at Postoperative Day 3
Measured: Pre-operative and day 3 post-operatively
Total Tourniquet Time
Measured from the time point of the tourniquet inflation to deflation using the same watch/clock
Measured: Intra-operatively (on day of surgery = Day 0)
Amount of FLOSEAL Applied
Measured: Intra-operatively (Day 0)
Duration of Surgery
Measured: Time from first incision to complete wound closure (Day 0)
Transfusion Requirements - Packed Red Blood Cells
Measured: Intra-operatively (Day 0) thru Postoperative Day 3
Total Drain Output at Day 1 Post-operatively
Measured: 1 day post-operatively
Pain Management - Number of Days When Pain Medication Was Used
Each participant kept a knee pain management diary. The diary was used to document the pain medication taken on a daily basis.
While the participants were hospitalized, either they filled out the diary, or study team members collected the pain diary data and filled out the diary.
Measured: Pre-operatively (Day -1 to Day 0); and post-operatively daily thru week 6
Visual Analogue Scale (VAS) Pain Scores
Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.
Measured: Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3, Week 1, 2 and 6
Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Day 3
Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.
Measured: Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3
Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 1
Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.
Measured: Pre-operatively (Day -1 to Day 0) and post-operatively at Week 1
Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 2
Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.
Measured: Pre-operatively (Day -1 to Day 0) and post-operatively at Week 2
Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 6
Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.
Measured: Pre-operatively (Day -1 to Day 0) and post-operatively at Week 6
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
A well-validated scale to reflect problems in people with lower limb issues.
- Pain scale (5 items): 0 (none) to 10 (extreme pain) is used to grade each item, higher scores indicate greater pain. The overall pain scale = 0 (no pain) to 50 (extreme pain)
- Stiffness scale (2 items): 0 (none) to 10 (extreme stiffness) is used to grade each item, higher scores indicate greater stiffness. The overall stiffness scale = 0 (no stiffness) to 20 (extreme stiffness)
- Physical Activity Difficulty (PAD) scale (17 items): 0 (none) to 10 (extreme PAD) is used to grade each item, with higher scores indicating greater PAD. The overall PAD scale = 0 (no PAD) to 170 (extreme PAD)
Averages calculated by taking sum of all individual item scores listed above and dividing by total number of items, range = 0 (no issues) to 10 (extreme issues).
Total Scores calculated by taking sum of all individual item scores listed above, range = 0 (no issues) to 240 (extreme issues)
Postoperative (Postop)
Measured: Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
A well-validated scale to reflect problems in people with lower limb issues.
- Pain scale (5 items): 0 (none) to 10 (extreme pain) is used to grade each item, higher scores indicate greater pain. The overall pain scale = 0 (no pain) to 50 (extreme pain)
- Stiffness scale (2 items): 0 (none) to 10 (extreme stiffness) is used to grade each item, higher scores indicate greater stiffness. The overall stiffness scale = 0 (no stiffness) to 20 (extreme stiffness)
- Physical Activity Difficulty (PAD) scale (17 items): 0 (none) to 10 (extreme PAD) is used to grade each item, with higher scores indicating greater PAD. The overall PAD scale = 0 (no PAD) to 170 (extreme PAD) Averages calculated by taking sum of all individual item scores listed above and dividing by total number of items, range = 0 (no issues) to 10 (extreme issues).
Total Scores calculated by taking sum of all individual item scores listed above, range = 0 (no issues) to 240 (extreme issues).
Postoperative (Postop)
Measured: Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. Scores were included where data was available.
Measured: Preoperative, and Postoperative Weeks 1, 2, and 6
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. Scores were included where data was available.
Change in SF-36 Scores From Baseline = (Postoperative Week 1,2, or 6 Scores) - (Baseline Scores).
Measured: Baseline and Postoperative Weeks 1, 2, and 6
Length of Hospital Stay
Measured: From the day of hospitalization to the day of discharge
Proportion of Participants With Transfusion Requirements
Measured: Intra-operative
Proportion of Participants With Wound Complications (ie, Hematoma, Cellulitis, Dehiscence, Superficial or Deep Infection, and Persistent Drainage)
Measured: Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6
Proportion of Participants With Any Adverse Events or Serious Injuries During or After Surgery
Measured: Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
The number of participants responding affirmative in their rehabilitation diaries for each day
Measured: 60 days
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
The number of participants responding affirmative in their rehabilitation diaries for each day
Measured: 60 days
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
The number of participants responding affirmative in their rehabilitation diaries for each day
Measured: 60 days
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
The number of participants responding affirmative in their rehabilitation diaries for each day
Measured: 60 days
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
The number of participants responding affirmative in their rehabilitation diaries for each day
Measured: 60 days
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
The number of participants responding affirmative in their rehabilitation diaries for each day
Measured: 60 days
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
The number of participants responding affirmative in their rehabilitation diaries for each day
Measured: 60 days
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
The number of participants responding affirmative in their rehabilitation diaries for each day
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee Replacement SurgeryStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ildiko Szabo, MD, MBA, Study director, Baxter Innovations GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410240
- Sponsor's protocol ID
- 611001
- Status last verified
- May 2014
- First submitted
- 1 Aug 2011
- Last updated
- 6 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Single-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of FLOSEAL for Hemostasis in Primary Unilateral Total Knee Arthroplasty (TKA)
- ClinicalTrials.gov ID
- NCT01410240
- Acronym / sponsor ID
- 611001
- Conditions
- Knee Replacement Surgery, Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 Aug 2011 (estimated)
- Results
- Posted 6 Jun 2014
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 study is to compare the efficacy and safety of FLOSEAL to standard of care for hemostasis in subjects undergoing total knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SoC) | Active comparator | Procedure: Standard of CareSoC: conventional hemostatic techniques such as cautery and manual compression |
| FLOSEAL + Standard of Care (SoC) | Experimental | Drug: FLOSEAL Hemostatic Matrix + Standard of careFLOSEAL: consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant is 18 to 80 years of age inclusive at the time of screening
- Participant is planned for primary unilateral total knee arthroplasty
- Participant has signed the informed consent form
- Participant is in stable health (i.e., able to undergo surgery and participate in a follow-up program based on physical examination and medical history)
- Participant has a preoperative Hgb level > 10 g/dL
Key exclusion criteria (21 listed)
- Participant has had a previous total or partial knee arthroplasty or any surgery on the knee within the previous 6 months
- Participant has osteonecrosis or arthrotomy within the last year
- Participant has prior or current hardware in target knee
- Participant has had injections in the knee:
- Participant has had general surgery within 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareConventional hemostatic techniques, such as cautery and manual compression, will be used. | Procedure or surgery | Standard of Care (SoC) |
| FLOSEAL Hemostatic Matrix + Standard of careAlso: FLOSEALFLOSEAL will be applied topically to areas of the knee where bleeding is observed (e.g. cut bone surfaces, subcutaneous tissue, posterior joint capsule, synovial tissue, medial and lateral gutters, branches of the genicular vessels, and suprapatellar pouch) and will occur intraoperatively. Sufficient amounts of FLOSEAL will be applied quickly using the provided applicators, followed by immediate approximation with a damp gauze, lap pad or sponge for approximately 2 minutes. + Standard of care: conventional hemostatic techniques, such as cautery and manual compression, will be used | Drug | FLOSEAL + Standard of Care (SoC) |
Primary outcome
Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively
Time frame: Pre-operative and 2 days post-operatively
Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP)
Time frame: Throughout the study period, 1 year and 4 months
* Proportion of Participants who have serious injuries (SIs) related to IP * Proportion of Participants who have non-serious adverse events (non-SAEs) related to IP
32 secondary outcomes
Change in Hemoglobin (Hgb) Levels at Day 1 Post-operatively
Time frame: Pre-operative and day 1 post-operatively
Change in Hemoglobin (Hgb) Levels at Day 3 Post-operatively
Time frame: Pre-operative and day 3 post-operatively
Change From Baseline in Hematocrit (Hct) at Postoperative Day 1
Time frame: Pre-operative and day 1 post-operatively
Change From Baseline in Hematocrit (Hct) at Postoperative Day 2
Time frame: Pre-operative and day 2 post-operatively
Change From Baseline in Hematocrit (Hct) at Postoperative Day 3
Time frame: Pre-operative and day 3 post-operatively
Total Tourniquet Time
Time frame: Intra-operatively (on day of surgery = Day 0)
Amount of FLOSEAL Applied
Time frame: Intra-operatively (Day 0)
Duration of Surgery
Time frame: Time from first incision to complete wound closure (Day 0)
Transfusion Requirements - Packed Red Blood Cells
Time frame: Intra-operatively (Day 0) thru Postoperative Day 3
Total Drain Output at Day 1 Post-operatively
Time frame: 1 day post-operatively
Pain Management - Number of Days When Pain Medication Was Used
Time frame: Pre-operatively (Day -1 to Day 0); and post-operatively daily thru week 6
Visual Analogue Scale (VAS) Pain Scores
Time frame: Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3, Week 1, 2 and 6
Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Day 3
Time frame: Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3
Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 1
Time frame: Pre-operatively (Day -1 to Day 0) and post-operatively at Week 1
Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 2
Time frame: Pre-operatively (Day -1 to Day 0) and post-operatively at Week 2
Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 6
Time frame: Pre-operatively (Day -1 to Day 0) and post-operatively at Week 6
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Time frame: Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Time frame: Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Time frame: Preoperative, and Postoperative Weeks 1, 2, and 6
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Time frame: Baseline and Postoperative Weeks 1, 2, and 6
Length of Hospital Stay
Time frame: From the day of hospitalization to the day of discharge
Proportion of Participants With Transfusion Requirements
Time frame: Intra-operative
Proportion of Participants With Wound Complications (ie, Hematoma, Cellulitis, Dehiscence, Superficial or Deep Infection, and Persistent Drainage)
Time frame: Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6
Proportion of Participants With Any Adverse Events or Serious Injuries During or After Surgery
Time frame: Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Time frame: 60 days
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Time frame: 60 days
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Time frame: 60 days
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Time frame: 60 days
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Time frame: 60 days
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Time frame: 60 days
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Time frame: 60 days
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ildiko Szabo, MD, MBA study director
Baxter Innovations GmbH
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Knee Replacement Surgery and Osteoarthritis, run by Baxter Healthcare Corporation at 12 sites 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 7 inclusion and 21 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: finished, as of the sponsor's last update on 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively (time frame: Pre-operative and 2 days post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 6 Jun 2014.