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Trial of Essential Amino Acid Supplementation in Protein Deficient Patients Following Total Knee Arthroplasty

Randomized Control Trial of Essential Amino Acid Supplementation in Protein Deficient Patients Following Total Knee Arthroplasty

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02926235
Acronym
Amino Acid
Enrollment
50
Registered
2016-10-06
Start date
2016-04-30
Completion date
2022-05-14
Last updated
2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quad Atrophy

Keywords

Total Knee Arthroplasty

Brief summary

The goal of this trial is to assess the efficacy of essential amino acids (EAA) on muscle atrophy and malnutrition compared to a placebo in patients following a total knee arthroplasty. The investigators specific objectives included analysis of (1) muscle strength, (2) change in malnutrition, (3) perioperative complications (4) physical activity.

Detailed description

Three orthopedic surgeons will participate in the study (MBC, DJM, SAJ). The surgical procedure will be performed as per each surgeon's routine practice. Patients will be asked to ingest 20g of EAA or placebo two times a day between meals 1 week prior and 2 weeks postoperatively. Patients will be given a pill organizer that has two doses per day with either EAA or placebo. Thigh circumference will be measured at baseline, 2 weeks and 6 weeks post-operatively. The mid-thigh measurement will be taken while the patient stands erect with their feet slightly apart and their weight equally distributed. The girth measurement is taken perpendicular to the long axis of the thigh. The tape measure will be placed at the level midway between the trochanterion and tibiale laterale sites each time to ensure that the same location is measured each time. The investigators will measure strength using a handheld dynamometer and performing a straight leg raise and knee extension at 90 degrees on the operative and the non-operative leg preoperatively, 2 weeks and 6 weeks post-operatively. The medial and lateral epicondyles of the femur will be used to position the subject's knee joint through the axis of rotation on the dynamometer. Strength will be tested at 30, 45 and 60 degrees of flexion. Physical activity will be collected using the Knee Society Score at baseline and at 6 weeks postoperatively. After the trial is commenced, there will be no additional enrollment once study numbers have been met.

Interventions

Treatment arm

OTHERPlacebo

Sponsors

Hospital for Special Surgery, New York
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* All patients will be undergoing a primary unilateral total knee arthroplasty for a diagnosis of osteoarthritis

Exclusion criteria

* All patients who were wheelchair bound preoperatively * All patients who cannot participate in an outpatient physical therapy program for 3 days per week after surgery

Design outcomes

Primary

MeasureTime frameDescription
Change Quad StrengthChange between preop and 6 weeks.As Measured by Quad circumference in inches

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026