Observation of Wheeled Device Use After TKA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mobility Tool.
- Who it may be relevant to
- Registry conditions: Total Knee Arthroplasty. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Maneuverability is currently under appreciated by patients who are seeking mobility. This pilot study is examining how patients maneuverability and mobility will change with this novel mobility tool.
Detailed description
Individuals living with challenges that affect their mobility may lead to loss of independence, loss of activity and engagement with life. We are seeking individuals who are having a Total Knee Replacement and are seeking increased mobility using the Alinker, which is a non-motorized walking bike without pedals.
Each participant will receive the Alinker prior to surgery, and will be encouraged to use it as much as possible before surgery and during the 3-month post-operative period.
Interventions
- Device Mobility Tool
An A-Linker device will be given to 12 patients 3 months before their total knee arthroplasty
Primary outcome measures
- Mobility after surgery [Time frame: 6 months]
Secondary outcome measures (5)
- Determining intensity of pain [Time frame: 6 months]
- Change in knee society score [Time frame: 6 months]
- surgery cancellation [Time frame: 6 months]
- Use of gait aide [Time frame: 6 months]
- Time with Device [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Any person receiving Primary Total Knee Arthroplasty, ages 18-99
- Patient is mobile with no more than a single cane/single crutch assist preoperatively
Exclusion criteria
- Any person not receiving knee arthroplasty, ages under 18 or greater than 99
- Patient requires simultaneous or staged bilateral replacements, staged <90 days apart.
- Patients who have active claudication from a lumbar stenosis or peripheral vascular disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- 450 Broadway — Redwood City
Identifiers
NCT: NCT06080152 · 70192