Study Stopped
lack of participants
Evaluation of Proprioception in Patients With Total Hip Replacement
PROPRIO-ATA
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
July 14, 2022
CompletedFirst Posted
Study publicly available on registry
March 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedMay 25, 2023
May 1, 2023
1 year
July 14, 2022
May 23, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Clinical improvements
At baseline, 3 months, 6 months, and 12 months from surgery
Clinical improvements
At baseline, 3 months, 6 months, and 12 months from surgery
Patient satisfaction
At baseline, 3 months, 6 months, and 12 months from surgery
Study Arms (2)
Minimally Invasive Lateral Approach
ACTIVE COMPARATORAnterior Approach
ACTIVE COMPARATORInterventions
Each patient will be evaluated using clinical scales (BBS, HHS, HOOS, SF12) and ''Delos Proprioceptive System'' to assess postural stability and proprioception.
Eligibility Criteria
You may qualify if:
- Primary Osteoarthrosis
- BMI \< 35 kg/m\^2
- Able to stand in monopodalic support without aids / support
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS-Istituto Ortopedico Rizzoli
Bologna, 40136, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Rehabilitation Unit Head
Study Record Dates
First Submitted
July 14, 2022
First Posted
March 10, 2023
Study Start
April 1, 2022
Primary Completion
April 1, 2023
Study Completion
April 1, 2024
Last Updated
May 25, 2023
Record last verified: 2023-05