Nutritional Supplement for Postoperative Recovery
What You Need to Know Before You Apply
What is the purpose of this trial?
This study is looking at whether taking a nutritional supplement before and after knee replacement surgery affects normal recovery. The supplement is Xcelerated Recovery (XR), an over-the-counter supplement made with essential amino acids (EAAs), which are building blocks of protein that the body cannot make on its own.
Participants aged 65 and older with planned knee replacement surgery, and signs of nutritional risk or reduced muscle strength on short screening questionnaires, will be invited to join. Participants are assigned by chance to one of two groups. One group receives usual care plus the XR supplement, taken twice a day starting 7 days before surgery and continuing for 14 days after surgery. The other group receives usual care without the supplement. Everyone in the study wears a small temporary skin sensor (similar to a temporary tattoo) on the knee and uses a smartphone app to take scans that measure knee size. Participants also have in-person visits before surgery and 2 weeks and 1 month after surgery.
The main goal is to measure how knee and leg size (circumference) changes after surgery in each group. Researchers will also look at muscle strength, knee movement, walking and mobility tests, and reported pain. This study is not testing the supplement as a treatment for any disease or medical condition. The results may help researchers better understand how nutrition relates to normal recovery after knee replacement surgery.
Who Is on the Research Team?
Stefano Bini, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for people aged 65 or older who are scheduled for knee replacement surgery and show signs of poor nutrition or reduced muscle strength on a short screening test.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Xcelerated Recovery Nutritional Supplement
Trial Overview
The study tests if taking the Xcelerated Recovery (XR) nutritional supplement before and after knee surgery helps with recovery. Participants are randomly assigned to get either usual care plus XR, or just usual care. The main focus is on changes in leg swelling and other recovery measures.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants randomized to this arm will receive the Xcelerated Recovery (XR) nutritional supplement in addition to standard perioperative care. Participants will dissolve the full XR supplement dissolved in water which includes 19.2 g of essential amino acids twice daily (38.4 g/day), beginning 7 days before total knee arthroplasty and continuing through 14 days after surgery. Participants will also undergo the study's scheduled assessments and exploratory InkWell monitoring.
Participants randomized to this arm will receive standard perioperative care without the Xcelerated Recovery nutritional supplement. Participants will undergo the same scheduled study assessments and exploratory InkWell monitoring as the intervention group.
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Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
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