NCT03579329

Brief Summary

Sarcopenia is a wasting disease with the locomotion system in the aged population. It is defined as the decline in muscle mass (lean body mass) and strength with the advance of age. The prevalence of sarcopenia increases with age, reaching an astounding 50% among the population aged over 75 in the United States. Sarcopenia is often associated with frailty, falls, and disability. Studies have found sarcopenia can be a predicting risk factor for fractures in the elderly. In addition, sarcopenia predicted a higher chance of mortality in nursing homes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
1.8 years until next milestone

Study Start

First participant enrolled

April 30, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2022

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

1.8 years

First QC Date

June 26, 2018

Last Update Submit

March 21, 2022

Conditions

Keywords

sarcopeniaOsteoarthritisTotal Knee Arthroplasty

Outcome Measures

Primary Outcomes (2)

  • International Physical Activity Questionnaire (IPAQ)

    Questionnaire

    one year

  • DXA scan

    Lean Muscle Mass Index

    one year

Secondary Outcomes (2)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    one year

  • Self-Rated 12

    one year

Interventions

Effect of Total Knee Arthroplasty on Sarcopenia in Patients with Osteoarthritis in the Knee

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

End stage knee osteoarthritis

You may qualify if:

  • Male and Female aged over 18 wirh end stage knee OA
  • Scheduled for TKA
  • Agree to provide written consent

You may not qualify if:

  • History of alcoholism or drug abuse
  • Pregnancy and breast-feeding
  • Presence of serious pathologies
  • Steroid-based systemic therapy in progress or interrupted since less than 1 month
  • With significant hematologic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Ho KK, Lau LC, Chau WW, Poon Q, Chung KY, Wong RM. End-stage knee osteoarthritis with and without sarcopenia and the effect of knee arthroplasty - a prospective cohort study. BMC Geriatr. 2021 Jan 4;21(1):2. doi: 10.1186/s12877-020-01929-6.

MeSH Terms

Conditions

SarcopeniaOsteoarthritis, KneeOsteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professional Consultant

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 6, 2018

Study Start

April 30, 2020

Primary Completion

February 2, 2022

Study Completion

February 2, 2022

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations