NCT03365284

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2017

Enrollment Period

2 years

First QC Date

November 25, 2017

Last Update Submit

December 2, 2017

Conditions

Arthroplasty, Replacement, KneeKnee Osteoarthritis

Keywords

total knee arthroplastyrehabilitationSmart Kneebrace

Outcome Measures

Primary Outcomes (1)

  • The change of postoperative joint angles

    Patients in both groups will wear the smart kneebrace by which the range of motion of the knee joint can be calculated.

    before operation and 6/12 weeks after operation

Secondary Outcomes (2)

  • 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

Study Arms (2)

Smart Kneebrace

EXPERIMENTAL

Smart Kneebrace with a smart phone app will be used during the rehabilitation after surgery for three months

Device: Smart Kneebrace with a smart phone app

without Smart Kneebrace

PLACEBO COMPARATOR

regular rehabilitation procedure will be applied after surgery

Other: regular rehabilitation procedure

Interventions

Smart Kneebrace with a smart phone appDEVICE

Smart Kneebrace will be used during the rehabilitation. Patients wearing the Smart KneeBrace are able to know their daily activity summary and exercise performance during rehabilitation training through a smart phone app.

Smart Kneebrace
regular rehabilitation procedureOTHER

regular rehabilitation procedure, especially muscle strengthening exercises

without Smart Kneebrace

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ready to receive single-side TKA

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Patel S, Park H, Bonato P, Chan L, Rodgers M. A review of wearable sensors and systems with application in rehabilitation. J Neuroeng Rehabil. 2012 Apr 20;9:21. doi: 10.1186/1743-0003-9-21.

    PMID: 22520559BACKGROUND

  • Sosdian L, Dobson F, Wrigley TV, Paterson K, Bennell K, Dowsey M, Choong P, Allison K, Hinman RS. Longitudinal changes in knee kinematics and moments following knee arthroplasty: a systematic review. Knee. 2014 Dec;21(6):994-1008. doi: 10.1016/j.knee.2014.09.009. Epub 2014 Oct 12.

    PMID: 25311517BACKGROUND

  • Mills K, Hunt MA, Ferber R. Biomechanical deviations during level walking associated with knee osteoarthritis: a systematic review and meta-analysis. Arthritis Care Res (Hoboken). 2013 Oct;65(10):1643-65. doi: 10.1002/acr.22015.

    PMID: 23554153BACKGROUND

  • Brostrom EW, Esbjornsson AC, von Heideken J, Iversen MD. Gait deviations in individuals with inflammatory joint diseases and osteoarthritis and the usage of three-dimensional gait analysis. Best Pract Res Clin Rheumatol. 2012 Jun;26(3):409-22. doi: 10.1016/j.berh.2012.05.007.

    PMID: 22867935BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jianhao Lin, MD

    Arthritis clinic and research center, Peking University Peoples' Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiwei Zhou

CONTACT

+8613521817377zzwwwdz@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor ofarthritis clinic and research center

Study Record Dates

First Submitted

November 25, 2017

First Posted

December 7, 2017

Study Start

January 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

December 7, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share