Failed Total Knee Arthroplasty
Conditions
Brief summary
This prospective study will evaluate the effectiveness of Vitagel (VG) in reducing blood loss associated with Revision Total Knee Arthroplasty (RTKA) procedures by assessing the patient's change in hemoglobin/hematocrit. Transfusion rates with the use of VG compared to the current standard of care will also be evaluated. The effectiveness of VG to potentially reduce pain, and increase return to function and quality of life will be assessed through the modified Knee Injury and Osteoarthritis Outcome Score (Modified KOOS), the Numerical Assessment Pain Scale (NAPS), and the SF-12 health survey. Analgesic use will be recorded post-operatively.
Detailed description
This is a prospective, randomized, blinded clinical trial involving 4 orthopedic surgeons who perform Revision Total Knee Arthroplasty (RTKA), including Trevor Murray (PI), Viktor Krebs, Robert Molloy, and Carlos Higuera. A total of eighty subjects scheduled for RTKA, who meet all inclusion criteria and exhibit none of the exclusion criteria will be invited to participate in the study. Only subjects who sign the Institutional Review Board-approved Informed Consent Form will be entered into the Study. In the forty treatment Subjects, VG will be applied to each surgical site. The forty control subjects will receive the surgeon's standard of care, without the use of any other hemostatic agents. The subjects will not be informed of their assignment, and the research investigator making the determination on blood transfusion requirements for all study subjects will also be blinded to the subject assigned arm of the study. The research investigator performing RTKA will remain blinded to the study arm until the randomization envelope is opened, which will take place during surgery, after hemostasis is achieved using bovie electrocautery, and prior to closure of the knee capsule. Assessments will be made per the Time and Events Schedule. Subjects will be evaluated for intra- and post-operative complications, and all such events, should they occur, will be recorded during the course of the study. Details describing the event, cause of event, its treatment and resolution will be documented.
Interventions
DEVICEVitagel
Vitagel
Sponsors
Stryker Nordic
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients must meet all of the following criteria in order to be considered appropriate candidates for participation in the study: 1. Is scheduled for RTKA (may be the second stage/reimplantation of a two-stage revision for infection); 2. Is able and willing to provide voluntary written informed consent for participation in the study and able to comply with protocol requirements; 3. Is between the ages of 18 and 85 at the time of surgery. Both male and female will be included; 4. Is physically and mentally willing and able to comply with the clinical and evaluation follow-up schedule;
Exclusion criteria
* The following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transfusion Requirements | Participants will be followed for the duration of hospital stay, an expected average of 12 weeks. | The primary objective of this study is to test for significant differences in transfusion requirements in patients managed with RTKA. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group Vitagel
Vitagel: Vitagel | 3 |
| Control Standard of care for surgical hemostasis. | 5 |
| Total | 8 |
Baseline characteristics
| Characteristic | Treatment Group | Control | Total |
|---|---|---|---|
| Age, Continuous | 64 years | 57.8 years | 60.1 years |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 5 |
| other Total, other adverse events | 0 / 3 | 0 / 5 |
| serious Total, serious adverse events | 0 / 3 | 1 / 5 |
Outcome results
Primary
Transfusion Requirements
The primary objective of this study is to test for significant differences in transfusion requirements in patients managed with RTKA.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.
Population: Data were not collected from participants enrolled in the study
| Arm | Measure | Value |
|---|---|---|
| Treatment Group | Transfusion Requirements | 0 |
| Control | Transfusion Requirements | 0 |