NCT04258917

Brief Summary

Study withdrawn

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2021

Status
withdrawn

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

February 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

January 8, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2022

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

February 3, 2020

Last Update Submit

April 11, 2022

Conditions

Keywords

crutchesgaitmobilityadultknee replacementACL tear

Outcome Measures

Primary Outcomes (1)

  • Range of scapular downward rotation

    Measured during gait assessment on post-operative day 4-12

Secondary Outcomes (3)

  • Bilateral upper extremity kinematics

    Measured during gait assessment on post-operative day 4-12

  • Bilateral upper extremity electromyographic (EMG) activity

    Measured during gait assessment on post-operative day 4-12

  • Upper extremity pain

    Measured at 3 time points: pre-operative, during gait assessment, and 4 weeks post-operative

Other Outcomes (5)

  • Weight-bearing lower extremity kinematics

    Measured during gait assessment on post-operative day 4-12

  • Torso kinematics

    Measured during gait assessment on post-operative day 4-12

  • Spatiotemporal parameters

    Measured during gait assessment on post-operative day 4-12

  • +2 more other outcomes

Study Arms (2)

Total Knee Arthroplasty

EXPERIMENTAL
Device: Study withdrawn

Anterior Cruciate Ligament Reconstruction

EXPERIMENTAL
Device: Study withdrawn

Interventions

Study withdrawn

Anterior Cruciate Ligament ReconstructionTotal Knee Arthroplasty

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects 45-75 years old planning to get their first total knee replacement
  • Subjects 18-45 years old planning to get their first anterior cruciate ligament reconstruction

You may not qualify if:

  • Previous injury to shoulder, elbow, or wrist
  • Current pain in shoulder, elbow, or wrist
  • Inflammatory arthritis (i.e. rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis),
  • History of cerebral palsy, stroke, significant cognitive impairment, or significant visual impairment
  • Problems with the heart or lungs
  • Currently using a crutch or crutches, walker, or other gait aid
  • History of using a crutch or crutches for 4 or more weeks
  • Inability to communicate in English
  • Current smoker
  • Currently pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Ranita Manocha, MD, MSc

    Department of Clinical Neurosciences, University of Calgary

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

February 3, 2020

First Posted

February 6, 2020

Study Start

January 8, 2021

Primary Completion

January 8, 2022

Study Completion

April 11, 2022

Last Updated

April 18, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share