Trial · NCT07899762
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mid-Patellar Circumference From Baseline | Baseline (preoperative), 2 weeks postoperative, and 1 month postoperative | Mid-patellar circumference of the operative knee will be measured in centimeters using a standardized measurement technique. Change from the preoperative baseline measurement will be compared between the Xcelerated Recovery nutritional supplement and control groups as a measure of postoperative tissue fluid balance. |
| Secondary | Change in Operative Knee Range of Motion From Baseline | Baseline (preoperative), 2 weeks postoperative, and 1 month postoperative | Operative knee flexion and extension will be measured in degrees. Measurements will be obtained using the same standardized approach at each study visit to evaluate change in knee mobility during postoperative recovery. |
| Secondary | Change in Timed Up and Go Test Time From Baseline | Baseline (preoperative), 2 weeks postoperative, and 1 month postoperative | Functional mobility will be assessed using the Timed Up and Go test. Participants will stand from a chair, walk to a designated point, turn, return to the chair, and sit down. Completion time will be recorded in seconds. |
| Secondary | Change in 10-Meter Walk Test Performance From Baseline | Baseline (preoperative), 2 weeks postoperative, and 1 month postoperative | Participants will complete the 10-meter walk test at the participant's usual walking pace. Walking performance will be assessed using the prespecified study metric. |
| Secondary | Change in Operative-Leg Quadriceps Strength From Baseline | Baseline (preoperative), 2 weeks postoperative, and 1 month postoperative | Quadriceps strength of the operative leg will be measured using a handheld dynamometer while the participant is seated with the knee flexed. Participants will push against the handheld device as strongly as comfortably possible. Strength will be recorded using the prespecified dynamometer measurement unit. |
| Secondary | Change in Pain Score From Baseline using the Visual Analog Scale (VAS) | Baseline (preoperative), 2 weeks postoperative, and 1 month postoperative | Participant-reported pain will be assessed using the Visual Analog Scale (VAS) ranging from 1 (no pain) to 10 (worse pain possible). Pain scores will be collected before surgery and at postoperative follow-up visits. |
| Secondary | Hospital Length of Stay in days following surgery until participant returns home | From surgical admission through hospital discharge, up to 6 weeks | Length of stay following total knee arthroplasty will be determined from the medical record and recorded as the time from hospital admission to discharge. |
| Secondary | All-Cause Hospital Readmission Within 30 Days | Within 30 days after surgery | The occurrence of hospital readmission following total knee arthroplasty will be determined through review of the medical record and recorded as the number and proportion of participants with at least one readmission. |
| Secondary | Postoperative Complications | From surgery through 1 month postoperative | Postoperative complications documented in the medical record will be collected and compared between study groups. |
| Secondary | Xcelerated Recovery Nutritional Supplement Adherence | From 7 days before surgery through 14 days after surgery | Participants assigned to the Xcelerated Recovery group will report the number of prescribed supplement doses missed during the supplementation period. Adherence will be summarized based on completed versus prescribed doses. |
| Other | InkWell Sensor Measurement of Postoperative Tissue Fluid Changes | From 7 days preoperative through 14 days postoperative | The InkWell Health temporary skin sensor and associated mobile application will generate exploratory measurements related to changes in tissue fluid status. InkWell-derived measurements will be compared with standardized circumference measurements. |
| Other | InkWell Sensor-Derived Knee Range of Motion | From 7 days preoperative through 14 days postoperative | Knee range of motion estimates generated by the InkWell monitoring platform will be collected as an exploratory outcome and compared with standardized range-of-motion measurements. |
| Other | Skin Temperature Measured Using InkWell Sensor | From 7 days preoperative through 14 days postoperative | Skin temperature measurements generated by the InkWell monitoring platform will be collected as an exploratory measure during the perioperative monitoring period. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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