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Tourniquet on Total Knee Arthroplasty
NA trial testing tourniquet in Arthritis Knee in 165 participants. Completed in 27 November 2024.
| Lead sponsor | Washington University School of Medicine |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 165 |
| Start date | 1 November 2020 |
| Primary completion | 30 November 2023 |
| Estimated completion | 27 November 2024 |
| Sites | 1 location across United States |
Washington University School of Medicine
18 and older, any sex, with Arthritis Knee. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Effect of tourniquet use on pain after TKA, 0-10 scale with 10 being higher pain, VAS pain survey
| Group | Value | 95% CI |
|---|---|---|
| Tourniquet During Surgery | 2.8 | ± 1.5 |
| No Tourniquet During Surgery | 2.6 | ± 1.8 |
Effect of tourniquet use on functional recovery after TKA. Score each question (item) from 0 to 4 with 0 being the worst outcome and 4 being the best outcome. The scores are then summed to produce an overall score running from 0 (worst possible) to 48 (best outcome).
| Group | Value | 95% CI |
|---|---|---|
| Tourniquet During Surgery | 43.0 | ± 6.28 |
| No Tourniquet During Surgery | 41.37 | ± 8.84 |
Effect of tourniquet use on functional recovery after TKA. Scale measures how much patient is aware of their joint after surgery. a total of 12 questions are answered asking about awareness of the knee joint. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score. Final score = 100 - ((sum(item01 to item12) - 12)/48\*100) 0:Represents the worst possible score, indicating the highest level of joint awareness and th
| Group | Value | 95% CI |
|---|---|---|
| Tourniquet During Surgery | 68.4 | ± 28.2 |
| No Tourniquet During Surgery | 70.9 | ± 77.4 |
Effect of tourniquet use on functional recovery after TKA measured by a score of 0-100, 100 being knee feels normal, 0 means knee does not feel normal
| Group | Value | 95% CI |
|---|---|---|
| Tourniquet During Surgery | 79.3 | ± 90 |
| No Tourniquet During Surgery | 81.5 | ± 20.1 |
Investigate sleep quality in post-operative period after TKA using fitbit tracker average hours of sleep at night
| Group | Value | 95% CI |
|---|---|---|
| Tourniquet During Surgery | 5.41 | ± 2.23 |
| No Tourniquet During Surgery | 6.47 | ± 1.63 |
effect of tourniquet use on total calculated blood loss after TKA. this is calculated by change in hemoglobin in g/dL from preop to periop.
| Group | Value | 95% CI |
|---|---|---|
| Tourniquet During Surgery | 13.9 | ± 1.4 |
| No Tourniquet During Surgery | 11.5 | ± 1.3 |
Time frame: Ae's collected up to 1 year.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Tourniquet During Surgery | No Tourniquet During Surgery |
|---|---|---|---|
| urinary retention lower abdominal and back pain | Hepatobiliary disorders | — | — |
Most-reported serious reactions: urinary retention lower abdominal and back pain.
Data from ClinicalTrials.gov NCT04923724 adverse events section.
The purpose of this study is determine the effect on novel pressure-regulating tourniquet use on pain, functional recovery, sleep and total blood loss following total knee arthroplasty.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04923724.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing