Evaluation of Proprioception in Patients With Total Hip Replacement (PROPRIO-ATA)

May 23, 2023 updated by: Mariagrazia Benedetti, Istituto Ortopedico Rizzoli

Disturbances of balance and postural stability are frequent in patients with coxarthrosis due to the damage to the mechanoreceptors, characteristic of arthritic degeneration, and muscular hypotrophy of the affected limb.

The aim of the study is to evaluate with adequate instrumentation the alterations of proprioception and postural control in patients with hip osteoarthrosis and the effectiveness of joint reconstruction in improving any deficit.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • IRCCS-Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Primary Osteoarthrosis
  • BMI < 35 kg/m^2
  • Able to stand in monopodalic support without aids / support

Exclusion Criteria:

  • History of previous hip or knee replacement
  • Orthopedic trauma within the previous 6 months
  • Pathologies that can interfere with balance: neurological (of the central nervous system, neuropathies, movement disorders), vestibular, visual, cognitive disability, consumption of alcohol / drugs / psychoactive drugs in the 24 hours prior to the test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anterior Approach
Diagnostic test: Clinical tests and proprioception evaluation
Each patient will be evaluated using clinical scales (BBS, HHS, HOOS, SF12) and ''Delos Proprioceptive System'' to assess postural stability and proprioception.
Active Comparator: Minimally Invasive Lateral Approach
Diagnostic test: Clinical tests and proprioception evaluation
Each patient will be evaluated using clinical scales (BBS, HHS, HOOS, SF12) and ''Delos Proprioceptive System'' to assess postural stability and proprioception.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline postural stability and proprioception
Time Frame: At baseline, 3 months, 6 months, and 12 months from surgery
Improvement of stability, evaluated with Berg Balance Scale, 0=minimum (the worst), 56 = maximum (the best)
At baseline, 3 months, 6 months, and 12 months from surgery
Change from baseline postural stability and proprioception
Time Frame: At baseline, 3 months, 6 months, and 12 months from surgery
Improvement of stability and proprioception, evaluated with Delos Proprioceptive System
At baseline, 3 months, 6 months, and 12 months from surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical improvements
Time Frame: At baseline, 3 months, 6 months, and 12 months from surgery
Evaluation of clinical improvements using the Harris Hip Score, 0=minimum (the worst), 100 = maximum (the best)
At baseline, 3 months, 6 months, and 12 months from surgery
Clinical improvements
Time Frame: At baseline, 3 months, 6 months, and 12 months from surgery
Evaluation of clinical improvements using the Patient Reported Outcome Measures with HOOS (Hip disability and Osteoarthritis Outcome Score) Physical Function shortform (HOOS-PS), 0=minimum (the worst), 100 = maximum (the best)
At baseline, 3 months, 6 months, and 12 months from surgery
Patient satisfaction
Time Frame: At baseline, 3 months, 6 months, and 12 months from surgery
Evaluation of patient satisfaction using the 12-Item Short Form Health Survey (SF-12) 0=minimum (the worst), 100 = maximum (the best)
At baseline, 3 months, 6 months, and 12 months from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Estimated)

April 1, 2023

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

July 14, 2022

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0004373

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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