Evaluation of Safety and Efficacy of ReHub in Patients Who Underwent Primary Total Knee Arthroplasty (REHAPT)

DyCare

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Other: Rapid Recovery Rehabilitation Programme; Device: ReHub

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04155957

DCEB28042019

Details and patient eligibility

About

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).

Enrollment: 52 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Conventional Rehabilitation Group

Active Comparator group

Description:

Participants follow the usual fast-track protocol used at Hospital Clínic de Barcelona for Total Knee Arthroplasty and perform a daily 5-exercise plan autonomously.

Treatment:

Other: Rapid Recovery Rehabilitation Programme

ReHub Group

Experimental group

Description:

Participants follow the usual fast-track protocol used at Hospital Clínic de Barcelona for Total Knee Arthroplasty but use the telerehabilitation platform ReHub to do the exercises in their rehabilitation plan at home and to have their progress monitored.

Treatment:

Device: ReHub

Other: Rapid Recovery Rehabilitation Programme