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Completed

NCT Number: NCT01410240

Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty

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.

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Key information

Conditions

Knee Replacement Surgery Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cedars-Sinai Orthopedic Center, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Standard of care

Procedure

Conventional hemostatic techniques, such as cautery and manual compression, will be used.

FLOSEAL Hemostatic Matrix + Standard of care

Drug

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

Other names: FLOSEAL

Primary outcomes

  1. Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively

    Time frame: Pre-operative and 2 days post-operatively

  2. 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

Secondary outcomes

  1. Change in Hemoglobin (Hgb) Levels at Day 1 Post-operatively

    Time frame: Pre-operative and day 1 post-operatively

  2. Change in Hemoglobin (Hgb) Levels at Day 3 Post-operatively

    Time frame: Pre-operative and day 3 post-operatively

    Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels.

  3. Change From Baseline in Hematocrit (Hct) at Postoperative Day 1

    Time frame: Pre-operative and day 1 post-operatively

    Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels.

  4. Change From Baseline in Hematocrit (Hct) at Postoperative Day 2

    Time frame: Pre-operative and day 2 post-operatively

  5. Change From Baseline in Hematocrit (Hct) at Postoperative Day 3

    Time frame: Pre-operative and day 3 post-operatively

  6. Total Tourniquet Time

    Time frame: Intra-operatively (on day of surgery = Day 0)

    Measured from the time point of the tourniquet inflation to deflation using the same watch/clock

  7. Amount of FLOSEAL Applied

    Time frame: Intra-operatively (Day 0)

  8. Duration of Surgery

    Time frame: Time from first incision to complete wound closure (Day 0)

  9. Transfusion Requirements - Packed Red Blood Cells

    Time frame: Intra-operatively (Day 0) thru Postoperative Day 3

  10. Total Drain Output at Day 1 Post-operatively

    Time frame: 1 day post-operatively

  11. 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

    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.

  12. 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

    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.

  13. 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

    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.

  14. 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

    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.

  15. 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

    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.

  16. 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

    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.

  17. 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

    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)

  18. 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

    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)

  19. 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

    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.

  20. Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6

    Time frame: Baseline and 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).

  21. Length of Hospital Stay

    Time frame: From the day of hospitalization to the day of discharge

  22. Proportion of Participants With Transfusion Requirements

    Time frame: Intra-operative

  23. 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

  24. 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

  25. Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist

    Time frame: 60 days

    The number of participants responding affirmative in their rehabilitation diaries for each day

  26. Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance

    Time frame: 60 days

    The number of participants responding affirmative in their rehabilitation diaries for each day

  27. Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker

    Time frame: 60 days

    The number of participants responding affirmative in their rehabilitation diaries for each day

  28. Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane

    Time frame: 60 days

    The number of participants responding affirmative in their rehabilitation diaries for each day

  29. Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair

    Time frame: 60 days

    The number of participants responding affirmative in their rehabilitation diaries for each day

  30. 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

    The number of participants responding affirmative in their rehabilitation diaries for each day

  31. Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed

    Time frame: 60 days

    The number of participants responding affirmative in their rehabilitation diaries for each day

  32. Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk

    Time frame: 60 days

    The number of participants responding affirmative in their rehabilitation diaries for each day

Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 5, 2011
Registry last updated
Jun 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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