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

Primary Purpose

Coxarthrosis; Primary

Status

Withdrawn

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Clinical tests and proprioception evaluation

About this trial

This is an interventional screening trial for Coxarthrosis; Primary

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

IRCCS-Istituto Ortopedico Rizzoli

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Minimally Invasive Lateral Approach

Anterior Approach

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline postural stability and proprioception

Improvement of stability, evaluated with Berg Balance Scale, 0=minimum (the worst), 56 = maximum (the best)

Change from baseline postural stability and proprioception

Improvement of stability and proprioception, evaluated with Delos Proprioceptive System

Secondary Outcome Measures

Clinical improvements

Evaluation of clinical improvements using the Harris Hip Score, 0=minimum (the worst), 100 = maximum (the best)

Clinical improvements

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)

Patient satisfaction

Evaluation of patient satisfaction using the 12-Item Short Form Health Survey (SF-12) 0=minimum (the worst), 100 = maximum (the best)

Full Information

NCT ID

NCT05763368

First Posted

July 14, 2022

Last Updated

May 23, 2023

Sponsor

Istituto Ortopedico Rizzoli

1. Study Identification

Unique Protocol Identification Number

NCT05763368

Brief Title

Evaluation of Proprioception in Patients With Total Hip Replacement

Acronym

PROPRIO-ATA

Official Title

Evaluation of Proprioception in Patients With Total Hip Replacement

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Withdrawn

Why Stopped

lack of participants

Study Start Date

April 1, 2022 (Actual)

Primary Completion Date

April 1, 2023 (Anticipated)

Study Completion Date

April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coxarthrosis; Primary

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Minimally Invasive Lateral Approach

Arm Type

Active Comparator

Arm Title

Anterior Approach

Arm Type

Active Comparator

Intervention Type

Diagnostic Test

Intervention Name(s)

Clinical tests and proprioception evaluation

Intervention Description

Each patient will be evaluated using clinical scales (BBS, HHS, HOOS, SF12) and ''Delos Proprioceptive System'' to assess postural stability and proprioception.

Primary Outcome Measure Information:

Title

Change from baseline postural stability and proprioception

Description

Improvement of stability, evaluated with Berg Balance Scale, 0=minimum (the worst), 56 = maximum (the best)

Time Frame

At baseline, 3 months, 6 months, and 12 months from surgery

Title

Change from baseline postural stability and proprioception

Description

Improvement of stability and proprioception, evaluated with Delos Proprioceptive System

Time Frame

At baseline, 3 months, 6 months, and 12 months from surgery

Secondary Outcome Measure Information:

Title

Clinical improvements

Description

Evaluation of clinical improvements using the Harris Hip Score, 0=minimum (the worst), 100 = maximum (the best)

Time Frame

At baseline, 3 months, 6 months, and 12 months from surgery

Title

Clinical improvements

Description

Time Frame

At baseline, 3 months, 6 months, and 12 months from surgery

Title

Patient satisfaction

Description

Evaluation of patient satisfaction using the 12-Item Short Form Health Survey (SF-12) 0=minimum (the worst), 100 = maximum (the best)

Time Frame

At baseline, 3 months, 6 months, and 12 months from surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

IRCCS-Istituto Ortopedico Rizzoli

City

Bologna

ZIP/Postal Code

40136

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Proprioception in Patients With Total Hip Replacement

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