NCT03837041

Brief Summary

The osteoarthritis (OA) is a chronic and degenerative disease which brings articular cartilage degeneration. As a consequence, balance and proprioception could be dangerously reduced after total knee arthroplasty. Several studies demonstrated the correlation between OA, proprioception reduction and increased risk of falling. The aim of this study is to evaluate the proprioception improvement in patients with total knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 19, 2024

Status Verified

May 1, 2023

Enrollment Period

4.4 years

First QC Date

February 7, 2019

Last Update Submit

September 9, 2024

Conditions

Proprioceptive Disorders

Keywords

total knee arthroplastyProprioceptionosteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Improvement of a proprioception

    Stability Index (SI) in percentage the maximum is 100%

    24 months

Secondary Outcomes (3)

  • Evaluation of performance in lower limb questionnaire

    24 months

  • KSS Score

    24 months

  • Clinical score

    24 months

Study Arms (2)

Reconditioning Proprioception group

ACTIVE COMPARATOR

Training Proprioception 1 hour for 2 day a week

Other: Reconditioning Proprioception

Control group

NO INTERVENTION

Interventions

Reconditioning ProprioceptionOTHER

Proprioceptive training using Delos Postural Proprioceptive System

Reconditioning Proprioception group

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Somatosensory DisordersOsteoarthritis

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor and Head of department

Study Record Dates

First Submitted

February 7, 2019

First Posted

February 11, 2019

Study Start

March 1, 2017

Primary Completion

July 31, 2021

Study Completion

December 31, 2021

Last Updated

September 19, 2024

Record last verified: 2023-05

Locations

IT(1)