What this study is
Simplified from ClinicalTrials.govTesting an over-the-counter essential amino acid supplement (Xcelerated Recovery, XR) to see whether it affects knee swelling and recovery after surgery, in adults 65 and older scheduled for knee replacement who show signs of nutritional risk or reduced muscle strength. Participants are assigned by chance to usual care with or without the supplement.
Read the original summary from ClinicalTrials.gov
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.
What's being tested
- Xcelerated Recovery Nutritional Supplement
Intervention · DRUG
Xcelerated Recovery (XR) is a commercially available, EAA-based multi-ingredient nutritional supplement. Participants assigned to the intervention arm will dissolve the full XR supplement in water and consume it twice daily. Each serving contains 19.2 g of essential amino acids, providing 38.4 g of essential amino acids per day. Supplementation will begin 7 days before total knee arthroplasty and continue through 14 days after surgery. XR is being evaluated for its association with measures of normal physiological recovery following surgery, including tissue fluid balance assessed through changes in limb circumference and measures of physical function.
Study details
- Official title
- Impact of Perioperative Nutritional Supplementation on Limb Circumference and Functional Recovery Following Elective Total Knee Arthroplasty: A Prospective Study
- Sponsor
- University of California, San Francisco
- Conditions
- Postoperative Recovery · Total Knee Arthroplasty
- Enrolling
- 80 people
- Starts
- 2027-01-01
- Est. completion
- 2027-05-01
- Design
- Open-label, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 65 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- Adults over 65 years old
- Nutritional deficiency, defined as MNA-SF ≤11, and/or sarcopenia, defined as SARC-F ≥4
- Undergoing elective primary unilateral total knee arthroplasty (TKA) for osteoarthritis at UCSF
- Able to provide written informed consent
- Willing to comply with supplementation and follow-up requirements
You can't join if
- Revision arthroplasty
- BMI >35 kg/m²
- Arthroplasty for inflammatory arthropathy, rheumatoid arthritis, or trauma
- Active cancer or severe metabolic disorder
- Chronic lower-extremity edema
- Preoperative ankle swelling
- Lymphedema
- Peripheral vascular disease
- History of deep vein thrombosis (DVT)
- Severe renal insufficiency
- Illicit drug use
- Known allergy to supplement ingredients
- Inability to consent
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUCSF Medical Center at Mount Zion
San Francisco, California, United States
- Malik Alhadi, BA · Contact559-999-1036malik.alhadi@ucsf.edu
Study team
Sponsor
University of California, San Francisco
Study ID STUDY00000269
Principal investigator
Stefano Bini, MD
University of California, San Francisco
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.