Total Hip ArthroplastyNCT03378986
Recovery After Total Hip Arthroplasty
An observational study of Total Hip Arthroplasty, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
This is an observational prospective study aimed to assess the lower limbs motor and functional recovery in patients who underwent to unilateral THA respect to simultaneous bilateral THA, in early postoperative phase. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Unilateral total hip arthroplasty and Simultaneous bilateral total hip arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 1 Jul 2018
- Phase
- Observational
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20 patients who undergone to unilateral THA and 20 patients who undergone to simultaneous bilateral THA
Who may be able to join
- from 40 to 65 years old
- primary THA for osteoarthritis
- ability to walk for 50 m without aids
Who cannot join
- severe dysplasia (Crowe III and IV)
- anchylosis, sub-anchylosis or surgical fusion of the coxophemoral joint
- traumatic event
- previous femoral and / or pelvic osteotomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Recovery After Monolateral or Bilateral Total Hip Arthroplasty
This is an observational prospective study aimed to assess the lower limbs motor and functional recovery in patients who underwent to unilateral THA respect to simultaneous bilateral THA, in early postoperative phase.
Read the detailed description
Introduction: Total hip arthroplasty (THA) represents a successful treatment for several hip joint pathologies. In case of bilateral hip joint involvement, the advancements in surgical techniques have made the development of bilateral THA surgery possible through one-stage procedure. This approach seems to be as safe as unilateral THA and safer than two-stage bilateral THA, but few studies considering functional outcomes in these patients without exploring outcomes linked to their motor and functional performance.
Objective: the aim of the study is to assess the lower limbs motor and functional recovery in patients who underwent to unilateral THA respect to simultaneous bilateral THA, in early postoperative phase.
Methods: 20 patients underwent to unilateral THA and 20 patients underwent to simultaneous bilateral THA will be recruited in the study. The partecipants will be aged from 40 to 65 years old, they will be undergone to primary THA for arthritis and the will be able to walk for 50 m without aids. Patients with severe dysplasia (Crowe III and IV), anchylosis, sub-anchylosis or surgical fusion of the coxophemoral joint, with traumatic event, or previous femoral and / or pelvic osteotomy, will be excluded from the study. Weight distribution and postural stability will be evaluated asking to participants to stay on two stabilometric platform with open eyes and closed eyes for 45 seconds. Gait analysis will be used to evaluate the spatio-temporal gait parametres and the ankle, knee, hip and pelvic kinematic. Pain during walking and patients' walking ability will be also evaluated throught Numeric Rating Scale (NRS) and Timed Up and Go test (TUG). Outcome measures will be collected the day before surgery, after three, seven and about forty days after surgery, except for gait analysis and Time Up and Go tests, which will not be recorded after three days.
Statistical analysis: normality and homogeneity of demographic variables and outcome measures at the baseline will be verified. Intergroup and intra-group post-intervention differences related to outcome measures will be investigated through ANOVA for repeated measurements including post hoc analysis.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Unilateral total hip arthroplasty, Simultaneous bilateral total hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral total hip arthroplastyProcedure or surgery
Replacement of one hip joint through a mininvasive surgical procedure
Simultaneous bilateral total hip arthroplastyProcedure or surgery
Replacement of both hip joints through one-stage mininvasive surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Unilateral THA | Patients who underwent to unilateral total hip arthroplasty Receives: Procedure: Unilateral total hip arthroplasty | |
| Bilateral THA | Patients who underwent to simultaneous bilateral total hip arthroplasty Receives: Procedure: Simultaneous bilateral total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight Distribution
Ability to simmetrically load their lower limbs
Measured: Before surgery, 3rd and 7th postoperative day
Change in Centre of Pressure Length of Trace
Ability to mantain balance
Measured: Before surgery, 3rd and 7th postoperative day
Secondary outcomes (3)
Gait analysis
Spatio-temporal parametres of the gait and joints kinematic
Measured: Before surgery and 7th postoperative day
Change in Numeric Rating Scale
Scale for pain assessment ranging from 0 (absence of pain) to 10 (maximum pain)
Measured: Before surgery, 3rd and 7th postoperative day
Change in Timed Up and Go Test
Test for evaluating walking ability
Measured: Before surgeryand 7th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start1 Jan 2018
- Primary completion31 May 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378986
- Sponsor's protocol ID
- CLF17/02
- Status last verified
- Dec 2017
- First submitted
- 1 Dec 2017
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Recovery After Monolateral or Bilateral Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03378986
- Acronym / sponsor ID
- CLF17/02
- Conditions
- Total Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 20 Dec 2017 (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.
This is an observational prospective study aimed to assess the lower limbs motor and functional recovery in patients who underwent to unilateral THA respect to simultaneous bilateral THA, in early postoperative phase.
Detailed description
Introduction: Total hip arthroplasty (THA) represents a successful treatment for several hip joint pathologies. In case of bilateral hip joint involvement, the advancements in surgical techniques have made the development of bilateral THA surgery possible through one-stage procedure. This approach seems to be as safe as unilateral THA and safer than two-stage bilateral THA, but few studies considering functional outcomes in these patients without exploring outcomes linked to their motor and functional performance.
Objective: the aim of the study is to assess the lower limbs motor and functional recovery in patients who underwent to unilateral THA respect to simultaneous bilateral THA, in early postoperative phase.
Methods: 20 patients underwent to unilateral THA and 20 patients underwent to simultaneous bilateral THA will be recruited in the study. The partecipants will be aged from 40 to 65 years old, they will be undergone to primary THA for arthritis and the will be able to walk for 50 m without aids. Patients with severe dysplasia (Crowe III and IV), anchylosis, sub-anchylosis or surgical fusion of the coxophemoral joint, with traumatic event, or previous femoral and / or pelvic osteotomy, will be excluded from the study. Weight distribution and postural stability will be evaluated asking to participants to stay on two stabilometric platform with open eyes and closed eyes for 45 seconds. Gait analysis will be used to evaluate the spatio-temporal gait parametres and the ankle, knee, hip and pelvic kinematic. Pain during walking and patients' walking ability will be also evaluated throught Numeric Rating Scale (NRS) and Timed Up and Go test (TUG). Outcome measures will be collected the day before surgery, after three, seven and about forty days after surgery, except for gait analysis and Time Up and Go tests, which will not be recorded after three days.
Statistical analysis: normality and homogeneity of demographic variables and outcome measures at the baseline will be verified. Intergroup and intra-group post-intervention differences related to outcome measures will be investigated through ANOVA for repeated measurements including post hoc analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral THA | – | Procedure: Unilateral total hip arthroplastyPatients who underwent to unilateral total hip arthroplasty |
| Bilateral THA | – | Procedure: Simultaneous bilateral total hip arthroplastyPatients who underwent to simultaneous bilateral total hip arthroplasty |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 patients who undergone to unilateral THA and 20 patients who undergone to simultaneous bilateral THA
Key inclusion criteria (3 listed)
- from 40 to 65 years old
- primary THA for osteoarthritis
- ability to walk for 50 m without aids
Key exclusion criteria (4 listed)
- severe dysplasia (Crowe III and IV)
- anchylosis, sub-anchylosis or surgical fusion of the coxophemoral joint
- traumatic event
- previous femoral and / or pelvic osteotomy
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 |
|---|---|---|
| Unilateral total hip arthroplastyReplacement of one hip joint through a mininvasive surgical procedure | Procedure or surgery | Unilateral THA |
| Simultaneous bilateral total hip arthroplastyReplacement of both hip joints through one-stage mininvasive surgical procedure | Procedure or surgery | Bilateral THA |
Primary outcome
Change in Weight Distribution
Time frame: Before surgery, 3rd and 7th postoperative day
Ability to simmetrically load their lower limbs
Change in Centre of Pressure Length of Trace
Time frame: Before surgery, 3rd and 7th postoperative day
Ability to mantain balance
3 secondary outcomes
Gait analysis
Time frame: Before surgery and 7th postoperative day
Change in Numeric Rating Scale
Time frame: Before surgery, 3rd and 7th postoperative day
Change in Timed Up and Go Test
Time frame: Before surgeryand 7th postoperative day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
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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?
An observational study of Total Hip Arthroplasty, run by Istituto Clinico Humanitas 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 4 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: finished, as of the sponsor's last update on 1 Jul 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in Weight Distribution (time frame: Before surgery, 3rd and 7th postoperative day). 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 1 Jul 2019.