Coxarthrosis; PrimaryPROPRIO-ATANCT05763368
Evaluation of Proprioception in Patients With Total Hip Replacement
A study testing Clinical tests and proprioception evaluation in people with Coxarthrosis; Primary, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Coxarthrosis; Primary
- What is being tested?
- Clinical tests and proprioception evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2022to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Osteoarthrosis
- BMI < 35 kg/m^2
- Able to stand in monopodalic support without aids / support
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Coxarthrosis; Primary
- Being tested
- Clinical tests and proprioception evaluation
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical tests and proprioception evaluationDiagnostic test
Each patient will be evaluated using clinical scales (BBS, HHS, HOOS, SF12) and ''Delos Proprioceptive System'' to assess postural stability and proprioception.
| Study group | Role | What they receive |
|---|---|---|
| Minimally Invasive Lateral Approach | Active comparator | Not described Receives: Diagnostic Test: Clinical tests and proprioception evaluation |
| Anterior Approach | Active comparator | Not described Receives: Diagnostic Test: Clinical tests and proprioception evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline postural stability and proprioception
Improvement of stability, evaluated with Berg Balance Scale, 0=minimum (the worst), 56 = maximum (the best)
Measured: 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
Measured: At baseline, 3 months, 6 months, and 12 months from surgery
Secondary outcomes (3)
Clinical improvements
Evaluation of clinical improvements using the Harris Hip Score, 0=minimum (the worst), 100 = maximum (the best)
Measured: 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)
Measured: 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)
Measured: At baseline, 3 months, 6 months, and 12 months from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Apr 2022
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Why it stopped: lack of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coxarthrosis; PrimaryStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariagrazia Benedetti, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763368
- Sponsor's protocol ID
- 0004373
- Acronym
- PROPRIO-ATA
- Status last verified
- May 2023
- First submitted
- 14 Jul 2022
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Proprioception in Patients With Total Hip Replacement
- ClinicalTrials.gov ID
- NCT05763368
- Acronym / sponsor ID
- PROPRIO-ATA / 0004373
- Conditions
- Coxarthrosis; Primary
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive Lateral Approach | Active comparator | Diagnostic Test: Clinical tests and proprioception evaluation |
| Anterior Approach | Active comparator | Diagnostic Test: Clinical tests and proprioception evaluation |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary Osteoarthrosis
- BMI < 35 kg/m^2
- Able to stand in monopodalic support without aids / support
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical tests and proprioception evaluationEach patient will be evaluated using clinical scales (BBS, HHS, HOOS, SF12) and ''Delos Proprioceptive System'' to assess postural stability and proprioception. | Diagnostic test | Anterior Approach, Minimally Invasive Lateral Approach |
Primary outcome
Change from baseline postural stability and proprioception
Time frame: At baseline, 3 months, 6 months, and 12 months from surgery
Improvement of stability, evaluated with Berg Balance Scale, 0=minimum (the worst), 56 = maximum (the best)
Change from baseline postural stability and proprioception
Time frame: At baseline, 3 months, 6 months, and 12 months from surgery
Improvement of stability and proprioception, evaluated with Delos Proprioceptive System
3 secondary outcomes
Clinical improvements
Time frame: At baseline, 3 months, 6 months, and 12 months from surgery
Clinical improvements
Time frame: At baseline, 3 months, 6 months, and 12 months from surgery
Patient satisfaction
Time frame: At baseline, 3 months, 6 months, and 12 months from surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical tests and proprioception evaluation in people with Coxarthrosis; Primary, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline postural stability and proprioception (time frame: At baseline, 3 months, 6 months, and 12 months from surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.