Effectiveness of a Mobile Telerehabilitation Tool Versus Conventional Treatment in Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Musculoskeletal Disorders; Knee Osteoarthritis (OA)

• Registration Number: NCT06735547
• Lead Sponsor: Sanitas University

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.

Study Timeline

• Study Start: 2023-12-01
• Primary Completion: 2024-03-30
• Status Verified: 2024-10
• Study Completion: 2024-10-10
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-12-10
• Last Update Submitted: 2024-12-10
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Knee Range of Motion	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).	Measurement of knee joint range of motion in flexion and extension using a goniometer from preoperative follow-up to the third month postoperatively.
Functionality - WOMAC survey	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).	WOMAC survey, validated in Colombia with a numerical result from 0 to 96, carried out during the preoperative visit until the third postoperative month.
Functionality - Get Up and Go	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).	Test that measures the time required to get up from the chair, walk to the mark 3 meters away, turn around and sit back in the chair, measured from preoperative follow-up to the third month postoperatively.
Pain - Visual Analogue Scale	Measured from day 0 every 24 hours until day 14 postoperatively.	Measurement of the patient's subjective perception of pain in a written survey and scale from 0 to 10.

Secondary Outcome Measures

Name	Time	Method
Number of therapy sessions	From the beginning of rehabilitation until the third postoperative month.	Number of face-to-face physical therapy sessions or TRAK therapy sessions.
Percentage of Adherence	From the beginning of rehabilitation until the third postoperative month.	Percentage of adherence to the prescribed rehabilitation program.
Patient Satisfaction	Measured at the end of rehabilitation, 3 months postoperatively	Measuring patient satisfaction with the prescribed rehabilitation program through a question with the option to respond: completely satisfied, satisfied, neither satisfied nor dissatisfied, somewhat satisfied, and not at all satisfied
Surgery Complications	Measured from the start of surgery to the third month postoperatively.	Complications derived from the surgical procedure: Material Failure, Dislocation, Fracture, Wound Dehiscence, Rigidity, Readmission, Death, Need for mobilization under anesthesia
Therapy Adverse Events	Measured from the start of the postoperative period to the third postoperative month.	Adverse events that occurred during the prescribed therapy sessions: Fall, Wound Dehiscence, Fracture, Ecchymosis, Ligament Injury, Need for intervention, Hematoma, Other

Trial Locations

Locations (1)

Clínica Universitaria Colombia; 🇨🇴 Bogotá, Colombia