Total Knee ArthroplastyNCT04258917
Impact of Crutch Type on Gait and Functional Outcomes Post-knee Surgery
A study testing Study withdrawn in people with Total Knee Arthroplasty and Anterior Cruciate Ligament Reconstruction, run by University of Calgary.
Trial summary
Study withdrawn Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Knee Arthroplasty, Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Study withdrawn
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 8 Jan 2021to 11 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- History of using a crutch or crutches for 4 or more weeks
- Inability to communicate in English
- Current smoker
- Currently pregnant
About this study
Official title: Impact of Crutch Type on Kinematics, Electromyography, Pain, and Comfort Following Knee Arthroplasty and Anterior Cruciate Ligament Reconstruction
Study withdrawn
Read the detailed description
Study withdrawn
- Being tested
- Study withdrawn
- Keywords
- crutches, gait, mobility, adult, knee replacement, ACL tear
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study withdrawnDevice
Study withdrawn
| Study group | Role | What they receive |
|---|---|---|
| Total Knee Arthroplasty | Experimental | Not described Receives: Device: Study withdrawn |
| Anterior Cruciate Ligament Reconstruction | Experimental | Not described Receives: Device: Study withdrawn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of scapular downward rotation
Measured: Measured during gait assessment on post-operative day 4-12
Secondary outcomes (3)
Bilateral upper extremity kinematics
Hip flexion/extension, knee flexion/extension, and ankle dorsiflexion/plantar flexion; measured through optical motion tracking software
Measured: Measured during gait assessment on post-operative day 4-12
Bilateral upper extremity electromyographic (EMG) activity
Measured: Measured during gait assessment on post-operative day 4-12
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)
Measured: Measured at 3 time points: pre-operative, during gait assessment, and 4 weeks post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start8 Jan 2021
- Primary completion8 Jan 2022
- Study completion11 Apr 2022
Why it stopped: Covid-19 pandemic prevented study from occuring
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lethbridge
- Responsible party
- Principal investigator, Ranita Manocha, University of Calgary
- Investigators
- Ranita Manocha, MD, MSc, Principal investigator, Department of Clinical Neurosciences, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258917
- Sponsor's protocol ID
- REB20-0047
- Status last verified
- Apr 2022
- First submitted
- 3 Feb 2020
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Crutch Type on Kinematics, Electromyography, Pain, and Comfort Following Knee Arthroplasty and Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT04258917
- Acronym / sponsor ID
- REB20-0047
- Keywords
- crutches, gait, mobility, adult, knee replacement, ACL tear
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Covid-19 pandemic prevented study from occuring
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of Lethbridge
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 8 Jan 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study withdrawn
Detailed description
Study withdrawn
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Knee Arthroplasty | Experimental | Device: Study withdrawn |
| Anterior Cruciate Ligament Reconstruction | Experimental | Device: Study withdrawn |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study withdrawnStudy withdrawn | Device | Anterior Cruciate Ligament Reconstruction, Total Knee Arthroplasty |
Primary outcome
Range of scapular downward rotation
Time frame: Measured during gait assessment on post-operative day 4-12
3 secondary outcomes
Bilateral upper extremity kinematics
Time frame: Measured during gait assessment on post-operative day 4-12
Bilateral upper extremity electromyographic (EMG) activity
Time frame: Measured during gait assessment on post-operative day 4-12
Upper extremity pain
Time frame: Measured at 3 time points: pre-operative, during gait assessment, and 4 weeks post-operative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ranita Manocha, MD, MSc principal investigator
Department of Clinical Neurosciences, University of Calgary
Questions about this trial
What is this clinical trial studying?
A study testing Study withdrawn in people with Total Knee Arthroplasty and Anterior Cruciate Ligament Reconstruction, run by University of Calgary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of scapular downward rotation (time frame: Measured during gait assessment on post-operative day 4-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.