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Nutritional Supplements for Joint Replacement Recovery

N/A

Recruiting

Led By Ran Schwarzkopf

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient are current candidates for elective primary total hip and total knee arthroplasty

Patients ≥55 years of age but ≤ 95

Must not have

Previous history of septic arthritis

End stage renal and hepatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 2 (2 wks pre) visit 3 (surgery day) visit 5 (4 weeks post)

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether giving extra nutrients to patients who are deficient in them can help improve recovery following joint replacement surgery.

Who is the study for?

This trial is for people aged 55 to 95 who are about to have hip or knee replacement surgery and show signs of poor nutrition (low levels of certain proteins in their blood). It's not for those with revision surgeries, protein absorption issues, eating disorders, past septic arthritis, severe kidney/liver disease, allergies to oral supplements, or can't take them by mouth.

What is being tested?

The study tests if a nutritional drink called Ensure can improve blood markers related to nutrition in patients who don't get enough nutrients and are having joint replacement surgery.

What are the potential side effects?

Ensure is generally safe but may cause digestive upset like diarrhea or constipation. Some might experience lactose intolerance symptoms if sensitive. Allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a first-time hip or knee replacement surgery.

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I am between 55 and 95 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had septic arthritis in the past.

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My kidneys and liver are not in the final stages of failure.

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I have a condition that prevents my body from absorbing proteins properly.

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I am having or have had surgery to replace or fix a joint, but not a full knee replacement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 2 (2 wks pre) visit 3 (surgery day) visit 5 (4 weeks post)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 2 (2 wks pre) visit 3 (surgery day) visit 5 (4 weeks post)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 2 (2 wks pre) visit 3 (surgery day) visit 5 (4 weeks post) for reporting.