Evaluation of Proprioception in Patients With Total Hip Replacement

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Proprioception in Patients With Total Hip Replacement

Conditions
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Coxarthrosis; Primary

Intervention / Treatment
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* Diagnostic Test: Clinical tests and proprioception evaluation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline postural stability and proprioception | 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 | 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 | 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 | 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 | 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 |