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WithdrawnNCT04258917Updated Apr 18, 2022

Impact of Crutch Type on Gait and Functional Outcomes Post-knee Surgery

An interventional study of Study withdrawn in Total Knee Arthroplasty and Anterior Cruciate Ligament Reconstruction, sponsored by University of Calgary. Withdrawn. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-18.

Sponsored by University of Calgary · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Covid-19 pandemic prevented study from occuring
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Study withdrawn

Read the detailed description

Study withdrawn

02

Conditions studied

  • Total Knee Arthroplasty
  • Anterior Cruciate Ligament Reconstruction

Keywords

  • crutches
  • gait
  • mobility
  • adult
  • knee replacement
  • ACL tear
03

In context

Lead sponsor

University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Total Knee Arthroplasty

    Device: Study withdrawn

  • Experimental
    Anterior Cruciate Ligament Reconstruction

    Device: Study withdrawn

Interventions

  • DeviceStudy withdrawn

    Study withdrawn

06

What researchers measure

Primary outcomes

  1. Range of scapular downward rotation

    Time frame: Measured during gait assessment on post-operative day 4-12

Secondary outcomes

  1. Bilateral upper extremity kinematics

    Hip flexion/extension, knee flexion/extension, and ankle dorsiflexion/plantar flexion; measured through optical motion tracking software

    Time frame: Measured during gait assessment on post-operative day 4-12

  2. Bilateral upper extremity electromyographic (EMG) activity

    Time frame: Measured during gait assessment on post-operative day 4-12

  3. Upper extremity pain

    Measurements of pain at the shoulder, elbow, and wrist using an 11-point Numerical Rating Scale (0 = no pain, 10 = extreme pain)

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

Other outcomes

  1. Weight-bearing lower extremity kinematics

    Hip flexion/extension, knee flexion/extension, and ankle dorsiflexion/plantar flexion; measured through optical motion tracking software

    Time frame: Measured during gait assessment on post-operative day 4-12

  2. Torso kinematics

    Thoracic flexion/extension; measured through optical motion tracking software

    Time frame: Measured during gait assessment on post-operative day 4-12

  3. Spatiotemporal parameters

    Gait velocity, crutch stride length, weight-bearing lower extremity stride length; measured through timing lights and computer software

    Time frame: Measured during gait assessment on post-operative day 4-12

  4. Crutch comfort

    Measured through an 11-point Numerical Rating Scale for both crutch types (0 = extremely uncomfortable, 10 = extremely comfortable)

    Time frame: Measured during gait assessment on post-operative day 4-12

  5. Number of falls

    Time frame: Measured at 4 weeks post-operation

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04258917
Lead sponsor
University of Calgary
Collaborators
University of Lethbridge
Responsible party
Ranita Manocha (Clinical Assistant Professor, University of Calgary) — Principal investigator
First posted
Feb 6, 2020
Start date
Jan 8, 2021
Primary completion
Jan 8, 2022
Completion
Apr 11, 2022
Last update
Apr 18, 2022

Study contacts

Ranita Manocha, MD, MSc
principal investigator · Department of Clinical Neurosciences, University of Calgary

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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