Trial Outcomes & Findings for Bone Wax Use for Hemostasis During Primary Unilateral Total Knee Arthroplasty (NCT NCT04992052)

Results Overview

To determine if there is a change in blood volume loss between the two study arms.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

52 participants

Primary outcome timeframe

Blood loss is measured the morning of postoperative day 1.

Results posted on

2023-11-21

Participant Flow

The study was terminated early due to slow enrollment.

Participant milestones

Participant milestones
Measure	Treatment Arm This arm will have bone wax applied to the exposed cancellous surfaces of the bone. Bone wax: The surgeons will apply the bone wax to the exposed cancellous bone after the implant has been cemented in place in patients randomized to the treatment arm.	Control Arm This arm will serve as the control group. Bone wax will not be used in this group.
Overall Study STARTED	29	23
Overall Study COMPLETED	29	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm n=29 Participants This arm will have bone wax applied to the exposed cancellous surfaces of the bone. Bone wax: The surgeons will apply the bone wax to the exposed cancellous bone after the implant has been cemented in place in patients randomized to the treatment arm.	Control Arm n=23 Participants This arm will serve as the control group. Bone wax will not be used in this group.	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=29 Participants	0 Participants n=23 Participants	0 Participants n=52 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=29 Participants	15 Participants n=23 Participants	30 Participants n=52 Participants
Age, Categorical >=65 years	14 Participants n=29 Participants	8 Participants n=23 Participants	22 Participants n=52 Participants
Sex: Female, Male Female	21 Participants n=29 Participants	17 Participants n=23 Participants	38 Participants n=52 Participants
Sex: Female, Male Male	8 Participants n=29 Participants	6 Participants n=23 Participants	14 Participants n=52 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Blood loss is measured the morning of postoperative day 1.

Population: One patient in the control arm did not have any blood work done on postoperative day 1, therefore, the blood loss analysis could not be calculated.

To determine if there is a change in blood volume loss between the two study arms.

Outcome measures

Outcome measures
Measure	Treatment Arm n=29 Participants This arm will have bone wax applied to the exposed cancellous surfaces of the bone. Bone wax: The surgeons will apply the bone wax to the exposed cancellous bone after the implant has been cemented in place in patients randomized to the treatment arm.	Control Arm n=22 Participants This arm will serve as the control group. Bone wax will not be used in this group.
Blood Loss	810.48 mililiters Standard Deviation 342.47	905.36 mililiters Standard Deviation 371.92

SECONDARY outcome

Timeframe: The Knee Society Score was collected within two months prior to the day of surgery and on postoperative day 56 with a collection window of +/- 2 weeks.

Population: 7 patients in the treatment arm and 4 patients in the control arm did not complete the postoperative knee society score.

To determine if there is a change in patient functional outcomes, as measured by the Knee Society Scoring System, between the two study arms. The minimum and maximum score for this scale ranges from 0-100. A higher score means a better outcome.

Outcome measures

Outcome measures
Measure	Treatment Arm n=22 Participants This arm will have bone wax applied to the exposed cancellous surfaces of the bone. Bone wax: The surgeons will apply the bone wax to the exposed cancellous bone after the implant has been cemented in place in patients randomized to the treatment arm.	Control Arm n=19 Participants This arm will serve as the control group. Bone wax will not be used in this group.
Knee Society Scoring System	62.55 score on a scale Standard Deviation 19.42	56.32 score on a scale Standard Deviation 15.36

Adverse Events

Treatment Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nancy Dengler, Clinical Research Nurse

Northwell Health System

Phone: 516-496-2637

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place