Evaluation of Proprioception in Patients With Total Hip Replacement

Not Applicable

Withdrawn

• Conditions: Coxarthrosis; Primary
• Interventions: Diagnostic Test: Clinical tests and proprioception evaluation

• Registration Number: NCT05763368
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-10
• Primary Completion: 2023-04-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-25
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anterior Approach	Clinical tests and proprioception evaluation	-
Minimally Invasive Lateral Approach	Clinical tests and proprioception evaluation	-

Primary Outcome Measures

Name	Time	Method
Change from baseline postural stability and proprioception	At baseline, 3 months, 6 months, and 12 months from surgery	Improvement of stability and proprioception, evaluated with Delos Proprioceptive System

Secondary Outcome Measures

Name	Time	Method
Clinical improvements	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)
Patient satisfaction	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)

Trial Locations

Locations (1)

IRCCS-Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy