Clinical trial NCT06735547: Effectiveness of a Mobile Telerehabilitation Tool Versus Conventional Treatment in Total Knee Arthroplasty
Official title: Effectiveness of a Mobile Telerehabilitation Tool Versus Conventional Treatment in Total Knee Arthroplasty: a Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Disorders
Knee Osteoarthritis (OA)
Keywords: Knee replacement arthroplasty
Telerehabilitation
Mobile applications
Artificial intelligence
Outpatient management
Lead sponsor: Sanitas University
Sponsor class: OTHER
Collaborators: name: Biokeralty Research Institute
First posted: 2024-12-16
Enrollment: 216
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Knee arthroplasty is one of the most common surgical procedures, and early rehabilitation is essential for patient recovery, pain modulation and a faster reintegration into daily life activities. However, it has been reported that the percentage of patients who continue rehabilitation for the time required to achieve these outcomes is much lower than those who abandon therapy. This is often due to various factors such as office hours, difficult access to appointments, and sometimes insufficient infrastructure and personnel to meet the demand. Currently, due to the global situation, it is crucial to conduct these rehabilitation processes remotely and virtually, making use of various technological tools that enable patients to interact with the healthcare professionals in charge of their rehabilitation. Among these tools are mobile applications on smartphones, which not only facilitate proper physical preparation, but also offer valuable real-time feedback. Furthermore, 8% of the total cost of knee joint replacements corresponds to the rehabilitation program. These costs are significantly reduced with telerehabilitation assisted by mobile tools, which not only improves patient access but also increases adherence and satisfaction levels by allowing the customization of rehabilitation programs based on each patient's specific needs and characteristics. The aim of this study is to evaluate the effectiveness outcomes of an artificial intelligence-guided mobile tool versus conventional rehabilitation during the first three months postoperatively following total knee replacement.

Detailed description: A parallel, controlled randomized clinical trial will be conducted. Study Population: Patients with knee osteoarthritis undergoing primary total knee replacement (TKR) at Clínica Universitaria Colombia and Puente Aranda Emergency Center, whose postoperative follow-up is ambulatory, and who meets the inclusion criteria.

Outcomes: Functionality will be the primary outcome, measured in terms of the WOMAC score, knee range of movement, and pain, by means of the visual analogue scale. Adherence to treatment, number of therapy sessions, patient satisfaction, and the presence of adverse events will also be measured.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with degenerative osteoarthritis with an indication for primary Total Knee Replacement (TKR) surgery at Clínica Universitaria Colombia or Central de Urgencias de Puente Aranda.
* Patients in the postoperative period following primary outpatient TKR.
* Patients with functional independence.
* Patients who agree to participate in the study and sign the informed consent form.
* Patients with access to a mobile device, tablet, computer, with internet access and the ability to operate it.
* Patients who have an appropriate space to perform therapy at home.
* Patients who will be accompanied during therapy sessions at home.

Exclusion Criteria:

* ASA Class IV (American Society of Anesthesiologists)
* BMI \> 35
* Dementia and cognitive impairment

Primary outcomes:
measure: Knee Range of Motion
timeFrame: Measurement will be performed before surgery (at the preoperative visit) and monthly during the first three months of the postoperative period (ending at 3 months postoperatively).
measure: Functionality - WOMAC survey
timeFrame: Measurement will be performed before surgery (at the preoperative visit) and monthly during the first three months of the postoperative period (ending at 3 months postoperatively).
measure: Functionality - Get Up and Go
timeFrame: Measurement will be performed before surgery (at the preoperative visit) and monthly during the first three months of the postoperative period (ending at 3 months postoperatively).
measure: Pain - Visual Analogue Scale
timeFrame: Measured from day 0 every 24 hours until day 14 postoperatively.
Secondary outcomes:
measure: Number of therapy sessions
timeFrame: From the beginning of rehabilitation until the third postoperative month.
measure: Percentage of Adherence
timeFrame: From the beginning of rehabilitation until the third postoperative month.
measure: Patient Satisfaction
timeFrame: Measured at the end of rehabilitation, 3 months postoperatively
measure: Surgery Complications
timeFrame: Measured from the start of surgery to the third month postoperatively.
measure: Therapy Adverse Events
timeFrame: Measured from the start of the postoperative period to the third postoperative month.
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Clínica Universitaria Colombia
Study officials:
References:
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