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Clinical Trials/NCT03365284
NCT03365284
Unknown
Not Applicable

Smart Kneebrace for Continuous Monitoring of Joint Angles During Rehabilitation After Total Knee Arthroplasty

Peking University People's Hospital0 sites60 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthroplasty, Replacement, Knee
Sponsor
Peking University People's Hospital
Enrollment
60
Primary Endpoint
The change of postoperative joint angles
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
December 31, 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yifan Chen

Clinical professor ofarthritis clinic and research center

Peking University People's Hospital

Eligibility Criteria

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)

Outcomes

Primary Outcomes

The change of postoperative joint angles

Time Frame: 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 Outcomes

  • The change of knee pain.(before operation and 6/12 weeks after operation)
  • The change of knee symptoms.(before operation and 6/12 weeks after operation)

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