Evaluation of Proprioception in Patients With Total Hip Replacement

Coxarthrosis; Primary Clinical Trial

— PROPRIO-ATA  

Official title:

Evaluation of Proprioception in Patients With Total Hip Replacement

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05763368
• Other study ID #: 0004373
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: May 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Coxarthrosis; Primary
• Osteoarthritis, Hip

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS-Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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