Smart Kneebrace for Continuous Monitoring of Joint Angles During Rehabilitation

Not Applicable

• Conditions: Arthroplasty, Replacement, Knee; Knee Osteoarthritis
• Interventions: Other: regular rehabilitation procedure; Device: Smart Kneebrace with a smart phone app

• Registration Number: NCT03365284
• Lead Sponsor: Peking University People's Hospital

Brief Summary

This study aims to investigate the effect of Smart Kneebrace use for osteoarthritis patients after total knee arhtroplasty (TKA) on post-operative performance.

Detailed Description

This is a single-center, open-label randomized controlled clinical trail. A total of 60 participants will receive total knee arthroplasty, who will be randomly assigned into experiment or control group. Smart Kneebrace will be used for the patients during the rehabilitation for the patients in experiment group, while the patients in the control group will not receive such a smart kneebrace. Postoperative joint angles as well as visual analog scale pain score, the Western Ontario and McMaster Universities Osteoarthritis Index knee society score will be estimated before operation and at 6/12 weeks after operation.

Study Timeline

• Study First Submitted: 2017-11-25
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-02
• Last Update Submitted: 2017-12-02
• Study First Posted: 2017-12-07
• Last Update Posted: 2017-12-07
• Study Start: 2018-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Ready to receive single-side TKA

Exclusion Criteria

• contraindication of surgery
• self-reported diseases that cause lower limb disability (for example, cerebrovascular disease especially stroke)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
without Smart Kneebrace	regular rehabilitation procedure	regular rehabilitation procedure will be applied after surgery
Smart Kneebrace	Smart Kneebrace with a smart phone app	Smart Kneebrace with a smart phone app will be used during the rehabilitation after surgery for three months

Primary Outcome Measures

Name	Time	Method
The change of postoperative joint angles	before operation and 6/12 weeks after operation	Patients in both groups will wear the smart kneebrace by which the range of motion of the knee joint can be calculated.

Secondary Outcome Measures

Name	Time	Method
The change of knee pain.	before operation and 6/12 weeks after operation	Visual Analogue Scale of pain is a scale to extimate pain, and its score ranges from 0 to 10. The higher the score is, the more severe pain the patient is feeling.
The change of knee symptoms.	before operation and 6/12 weeks after operation	The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC),and its score ranges from 0 to 96. The higher the score is, the more severe symptoms the patient is feeling.