Clinical trial NCT04155957: Evaluation of Safety and Efficacy of ReHub in Patients Who Underwent Primary Total Knee Arthroplasty
Official title: Evaluation of Safety and Efficacy of ReHub in Patients Who Underwent Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Bio-Sensing Solutions S.L. (DyCare)
Sponsor class: INDUSTRY
Collaborators: name: Hospital Clinic of Barcelona
name: EASME
First posted: 2019-11-07
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, non-blinded, parallel assignment, clinical trial for the evaluation of safety and efficacy of ReHub, a telerehabilitation system made up of a cloud platform and an exercise kit with smart sensors, for performing rehabilitation exercises after a primary Total Knee Arthroplasty.

Primary TKA patients are allocated randomly to the control arm or the experimental arm with a 1:1 ratio. Both arms follow the usual rapid recovery protocol for TKA surgeries at Hospital Clínic de Barcelona, which includes discharge after 2-3 days from the surgery, the prescription of a daily plan of 5 exercises for autonomous rehabilitation and domiciliary visits by a physiotherapist starting approximately 2 weeks after the surgery. The experimental arm participants use ReHub to do their exercises instead of working independently and physiotherapists monitor their performance and adherence remotely.

Outcomes assessment is performed at hospital discharge (baseline), at stitch removal (2 weeks after baseline) and 2 weeks after stitch removal (4 weeks after baseline).


Eligibility criteria: Inclusion Criteria:

* Candidates to primary TKA
* Age from 18 to 75 years old
* Ability to understand and accept the clinical study procedure and to sign an informed consent form
* Good predisposition to the use of technology or cohabitation with someone that can give them technological support
* Availability to attend the Hospital for control visits
* Patient resides in the area of influence of Hospital Clínic de Barcelona

Exclusion Criteria:

* Reluctance or inability to use technology
* Any type of disability that could alter the homogeneity of the study
* Sensory and/or cognitive impairment
* Concomitant medical conditions that may influence the rehabilitation process
* Any local or systemic complications after TKA surgery (e.g. surgical wound infection, suspicious of deep vein thrombosis)

Primary outcomes:
measure: Change in Active Knee Range of Motion (º)
timeFrame: Baseline, 2 weeks and 4 weeks after discharge
Secondary outcomes:
measure: Change in the Timed Up-and-Go test score (s)
timeFrame: Baseline, 2 weeks and 4 weeks after discharge
measure: Change in Self-Reported Pain Level: Visual Analogue Scale
timeFrame: Baseline, 2 weeks and 4 weeks after discharge
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
timeFrame: Baseline, 2 weeks and 4 weeks after discharge
measure: Change in EuroQol-5D-5L (EQ-5D-5L) score
timeFrame: Baseline, 2 weeks and 4 weeks after discharge
measure: Change in Quadriceps Strength (kg)
timeFrame: Baseline, 2 weeks and 4 weeks after discharge
measure: Change in Hamstring Strength (kg)
timeFrame: Baseline, 2 weeks and 4 weeks after discharge
measure: Satisfaction with ReHub: System Usability Scale
timeFrame: 4 weeks after discharge
measure: Change in Passive Knee Range of Motion (º)
timeFrame: Baseline, 2 weeks and 4 weeks after discharge
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Salvi Prat Fabregat
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nuevo M, Mahdavi H, Rodriguez D, Faura T, Fabrellas N, Balocco S, Conti M, Castagna A, Prat S. Evaluation of Safety and Efficacy of ReHub in Patients Who Underwent Primary Total Knee Arthroplasty: Study Protocol for a Randomized Controlled Trial. Int J Surg Protoc. 2021 Apr 19;25(1):34-41. doi: 10.29337/ijsp.138.