NCT02926235

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2022

Completed
Last Updated

August 8, 2022

Status Verified

August 1, 2022

Enrollment Period

6.1 years

First QC Date

June 24, 2016

Last Update Submit

August 5, 2022

Conditions

Quad Atrophy

Keywords

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Change Quad Strength

    As Measured by Quad circumference in inches

    Change between preop and 6 weeks.

Study Arms (2)

Amino Acid

EXPERIMENTAL

Patients will be asked to ingest 20g of EAA o two times a day between meals 1 week prior and 2 weeks postoperatively.

Drug: Amino Acid

Placebo

PLACEBO COMPARATOR

Patients will be asked to ingest 20g of placebo two times a day between meals 1 week prior and 2 weeks postoperatively.

Other: Placebo

Interventions

Amino AcidDRUG

Treatment arm

Amino Acid
PlaceboOTHER
Placebo

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Amino Acids

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

  • David Mayman, MD

    Hospital for Special Surgery, New York

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2016

First Posted

October 6, 2016

Study Start

April 1, 2016

Primary Completion

May 14, 2022

Study Completion

May 14, 2022

Last Updated

August 8, 2022

Record last verified: 2022-08

Locations

US(1)