Trial of Essential Amino Acid Supplementation in Protein Deficient Patients Following Total Knee Arthroplasty (Amino Acid)
Primary Purpose
Quad Atrophy
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Amino Acid
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Quad Atrophy focused on measuring Total Knee Arthroplasty
Eligibility Criteria
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
Sites / Locations
- Hospital for Special Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Amino Acid
Placebo
Arm Description
Patients will be asked to ingest 20g of EAA o two times a day between meals 1 week prior and 2 weeks postoperatively.
Patients will be asked to ingest 20g of placebo two times a day between meals 1 week prior and 2 weeks postoperatively.
Outcomes
Primary Outcome Measures
Change Quad Strength
As Measured by Quad circumference in inches
Secondary Outcome Measures
Full Information
NCT ID
NCT02926235
First Posted
June 24, 2016
Last Updated
August 5, 2022
Sponsor
Hospital for Special Surgery, New York
1. Study Identification
Unique Protocol Identification Number
NCT02926235
Brief Title
Trial of Essential Amino Acid Supplementation in Protein Deficient Patients Following Total Knee Arthroplasty
Acronym
Amino Acid
Official Title
Randomized Control Trial of Essential Amino Acid Supplementation in Protein Deficient Patients Following Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Study Start Date
April 2016 (undefined)
Primary Completion Date
May 14, 2022 (Actual)
Study Completion Date
May 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quad Atrophy
Keywords
Total Knee Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amino Acid
Arm Type
Experimental
Arm Description
Patients will be asked to ingest 20g of EAA o two times a day between meals 1 week prior and 2 weeks postoperatively.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will be asked to ingest 20g of placebo two times a day between meals 1 week prior and 2 weeks postoperatively.
Intervention Type
Drug
Intervention Name(s)
Amino Acid
Intervention Description
Treatment arm
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change Quad Strength
Description
As Measured by Quad circumference in inches
Time Frame
Change between preop and 6 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Mayman, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial of Essential Amino Acid Supplementation in Protein Deficient Patients Following Total Knee Arthroplasty
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