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

Sponsor

Istituto Ortopedico Rizzoli (Other)

Overall Status

Withdrawn

CT.gov ID

NCT05763368

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coxarthrosis; Primary	Diagnostic Test: Clinical tests and proprioception evaluation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Evaluation of Proprioception in Patients With Total Hip Replacement

Actual Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

Change from baseline postural stability and proprioception [Before the surgery, 3 months, 6 months, and 12 months from surgery]
Improvement of stability, evaluated with Berg Balance Scale
Change from baseline postural stability and proprioception [Before the surgery, 3 months, 6 months, and 12 months from surgery]
Improvement of stability and proprioception, evaluated with Delos Proprioceptive System

Secondary Outcome Measures

Clinical improvements [Before the surgery, 3 months, 6 months, and 12 months from surgery]
Evaluation of clinical improvements using the Harris Hip Score
Clinical improvements [Before the surgery, 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)
Patient satisfaction [Before the surgery, 3 months, 6 months, and 12 months from surgery]
Evaluation of patient satisfaction using the 12-Item Short Form Health Survey (SF-12)

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS-Istituto Ortopedico Rizzoli	Bologna		Italy	40136

Sponsors and Collaborators

Istituto Ortopedico Rizzoli

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mariagrazia Benedetti, Rehabilitation Unit Head, Istituto Ortopedico Rizzoli

ClinicalTrials.gov Identifier:

NCT05763368

Other Study ID Numbers:

0004373

First Posted:

Mar 10, 2023

Last Update Posted:

Mar 10, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoarthritis, Hip

Study Results

No Results Posted as of Mar 10, 2023