Hip OsteoarthritisArthroplastyNCT04214171
Kinematics and Muscle Strength in Two, Five or 10 Years Afther Total Hip Arthroplasty
An observational study of Hip Osteoarthritis, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial summary
Introduction: Femoral and acetabular replacement is characterized as total hip arthroplasty (THA). It has been used as treatment of various pathologies of this joint. In the postoperative period, some studies have shown that strength, function, range of motion and lower limb mechanics remains altered for more than One… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Gait and muscle strength will be assessed
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2017to 1 Feb 2019
- How long will I take part?
- 1 Day
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 40 individuals who underwent total hip arthroplasty (THA) by the hospital hip surgery group
Who may be able to join
- The investigators will recruit 40 individuals who underwent total hip arthroplasty (THA) by the hospital hip surgery group in the periods of two, five and 10 years postoperatively
- Control group without orthopaedic afections. Inclusion criteria: patients submitted to total hip arthroplasty between two years (24 months - 35 months), five years (60 months - 71 months) and 10 years (120 months - 131 months), aged between 50 and 80 years and sign the terms of free and informed consent
Who cannot join
- patients with a history of prosthesis dislocations or revision of arthroplasty
- hip or lower limb pain
- asymmetry of the lower limbs greater than two centimeters
- previous surgeries in the lower limbs
- limited range of motion in the hip joint
- use of antidepressive drugs or analgesics for continuous use
- Presence of neuromuscular pathologies and functional incapacity to perform the activities proposed in the Kinematics analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kinematics and Muscle Strength in Two, Five or 10 Years Afther Total Hip Arthroplasty: Comparison With Healthy Individuales Controlled Cross Sectional Study
Introduction: Femoral and acetabular replacement is characterized as total hip arthroplasty (THA). It has been used as treatment of various pathologies of this joint. In the postoperative period, some studies have shown that strength, function, range of motion and lower limb mechanics remains altered for more than One year after THA in relation to the non-operated side. However, studies that have correlated kinematics and hip muscle strength in individuals who underwent THA for long time, do not exist in literature. Objective: to evaluate lower limb muscle strength and 2D kinematics during stair ascending and descending in patients undergoing total hip arthroplasty. Methods: Third individuals who underwent total hip arthroplasty (THA) will be recruited at two, five and 10 year postoperative periods. They were allocated in three groups: Group 1 (10n), subjects submitted to THA for two years, Group 2 (10n) subjects submitted to THA for five years, Group 3 (10n) subjects submitted to THA for 10 years and Group 4 (10n) subjects without orthopaedic afections, all will be evaluated for dynamometric isometric muscle strength and kinematic analysis of stair ascending and descending by a "blinded" physical Therapist.
- Conditions
- Hip Osteoarthritis
- Being tested
- Gait and muscle strength will be assessed
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait and muscle strength will be assessedDiagnostic test
The extensor moment of the hip during gait and evaluation of the muscular strength of the hip will be evaluated
| Study group | Role | What they receive |
|---|---|---|
| group 2 years | The group underwent total hip arthroplasty at 2 years Receives: Diagnostic Test: Gait and muscle strength will be assessed | |
| group 5 years | The group underwent total hip arthroplasty at 5 years Receives: Diagnostic Test: Gait and muscle strength will be assessed | |
| group 10 years | The group underwent total hip arthroplasty at 10 years Receives: Diagnostic Test: Gait and muscle strength will be assessed | |
| group control | healthy patients Receives: Diagnostic Test: Gait and muscle strength will be assessed |
What is being measured
The primary outcome is the main question the study is designed to answer.
kinematic analysis of hip movements for flexion
Analysis of the movements of the hip - range of motion for flexion
Measured: evaluated at 10 years after hip arthroplasty
kinematic analysis of hip movements for extension
Analysis of the movements of the hip - range of motion for extension
Measured: evaluated at 10 years after hip arthroplasty
kinematic analysis of hip movements for internal rotation
Analysis of the movements of the hip - range of motion for internal rotation
Measured: evaluated at 10 years after hip arthroplasty
kinematic analysis of hip movements external rotation
Analysis of the movements of the hip - range of motion for external rotation
Measured: evaluated at 10 years after hip arthroplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Jan 2017
- Primary completion1 Sep 2017
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vera Lucia dos Santos Alves, Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Investigators
- Vera Lucia Santos Alves, Dr, Study director, Faculdade de Ciências Médicas da Santa Casa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214171
- Sponsor's protocol ID
- Joao B
- Acronym
- Arthroplasty
- Status last verified
- Sep 2020
- First submitted
- 3 Jan 2018
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Foucher KC, Cinnamon CC, Ryan CA, Chmell SJ, Dapiton K. Hip abductor strength and fatigue are associated with activity levels more than 1 year after total hip replacement. J Orthop Res. 2018 May;36(5):1519-1525. doi: 10.1002/jor.23783. Epub 2017 Nov 28.
PubMed 29077218
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinematics and Muscle Strength in Two, Five or 10 Years Afther Total Hip Arthroplasty: Comparison With Healthy Individuales Controlled Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04214171
- Acronym / sponsor ID
- Arthroplasty / Joao B
- Conditions
- Hip Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 2 Jan 2020 (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.
Introduction: Femoral and acetabular replacement is characterized as total hip arthroplasty (THA). It has been used as treatment of various pathologies of this joint. In the postoperative period, some studies have shown that strength, function, range of motion and lower limb mechanics remains altered for more than One year after THA in relation to the non-operated side. However, studies that have correlated kinematics and hip muscle strength in individuals who underwent THA for long time, do not exist in literature. Objective: to evaluate lower limb muscle strength and 2D kinematics during stair ascending and descending in patients undergoing total hip arthroplasty. Methods: Third individuals who underwent total hip arthroplasty (THA) will be recruited at two, five and 10 year postoperative periods. They were allocated in three groups: Group 1 (10n), subjects submitted to THA for two years, Group 2 (10n) subjects submitted to THA for five years, Group 3 (10n) subjects submitted to THA for 10 years and Group 4 (10n) subjects without orthopaedic afections, all will be evaluated for dynamometric isometric muscle strength and kinematic analysis of stair ascending and descending by a "blinded" physical Therapist.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 2 years | – | Diagnostic Test: Gait and muscle strength will be assessedThe group underwent total hip arthroplasty at 2 years |
| group 5 years | – | Diagnostic Test: Gait and muscle strength will be assessedThe group underwent total hip arthroplasty at 5 years |
| group 10 years | – | Diagnostic Test: Gait and muscle strength will be assessedThe group underwent total hip arthroplasty at 10 years |
| group control | – | Diagnostic Test: Gait and muscle strength will be assessedhealthy patients |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 individuals who underwent total hip arthroplasty (THA) by the hospital hip surgery group
Key inclusion criteria (2 listed)
- The investigators will recruit 40 individuals who underwent total hip arthroplasty (THA) by the hospital hip surgery group in the periods of two, five and 10 years postoperatively
- Control group without orthopaedic afections. Inclusion criteria: patients submitted to total hip arthroplasty between two years (24 months - 35 months), five years (60 months - 71 months) and 10 years (120 months - 131 months), aged between 50 and 80 years and sign the terms of free and informed consent
Key exclusion criteria (7 listed)
- patients with a history of prosthesis dislocations or revision of arthroplasty
- hip or lower limb pain
- asymmetry of the lower limbs greater than two centimeters
- previous surgeries in the lower limbs
- limited range of motion in the hip joint
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 |
|---|---|---|
| Gait and muscle strength will be assessedThe extensor moment of the hip during gait and evaluation of the muscular strength of the hip will be evaluated | Diagnostic test | group 10 years, group 2 years, group 5 years, group control |
Primary outcome
kinematic analysis of hip movements for flexion
Time frame: evaluated at 10 years after hip arthroplasty
Analysis of the movements of the hip - range of motion for flexion
kinematic analysis of hip movements for extension
Time frame: evaluated at 10 years after hip arthroplasty
Analysis of the movements of the hip - range of motion for extension
kinematic analysis of hip movements for internal rotation
Time frame: evaluated at 10 years after hip arthroplasty
Analysis of the movements of the hip - range of motion for internal rotation
kinematic analysis of hip movements external rotation
Time frame: evaluated at 10 years after hip arthroplasty
Analysis of the movements of the hip - range of motion for external rotation
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 9 Sep 2020.
- Results publication: PubMed 29077218Foucher KC, Cinnamon CC, Ryan CA, Chmell SJ, Dapiton K. Hip abductor strength and fatigue are associated with activity levels more than 1 year after total hip replacement. J Orthop Res. 2018 May;36(5):1519-1525. doi: 10.1002/jor.23783. Epub 2017 Nov 28.
- Individual participant dataSharing planned: No
Related trials for Hip Osteoarthritis
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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.
Vera Lucia Santos Alves, Dr study director
Faculdade de Ciências Médicas da Santa Casa de São Paulo
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 Hip Osteoarthritis, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
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 2 inclusion and 7 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 9 Sep 2020. 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 Brazil. 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?
kinematic analysis of hip movements for flexion (time frame: evaluated at 10 years after hip arthroplasty). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04214171, which also lists 1 linked publication.
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 9 Sep 2020.