Arthroplasty ComplicationsNCT03079479
Impact on Muscle Strength, Quality of Life and Functionality in Individuals Submitted to Hip Arthroplasty: a Prospective Study.
An observational study of Arthroplasty Complications and Arthropathy of Hip, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial summary
Introduction: Total hip arthroplasty has been increasingly used as a means of treating the various pathologies of this joint. However, this surgical reconstruction initially brings important deficits in subjects submitted, such as: inhibition of muscle strength, limitation of range of motion and functional deficit. Read more about this study
- Who is it for?
- Ages 56 to 70 years
- Conditions the study is for
- Arthroplasty Complications, Arthropathy of Hip
- What is being tested?
- Muscle Strenght assesment and 2D Kinematics Analysis
- How many people
- 65 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2016to 4 Jan 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 56 to 70 years
- All sexes
- Adult, Older adult
Study population: Patients with total hip arthroplasty through the postero lateral approach
Who may be able to join
- The inclusion criteria in the study will be: patients submitted to total hip arthroplasty between 2 years (24 months - 35 months), 5 years (60 months - 71 months) and 10 years (120 months - 131 months), age between 50 and 80 years and sign the terms of free and informed consent
Who cannot join
- The exclusion criteria will be: patients with a history of prosthesis dislocations or revision of the arthroplasty, pain in the hip or lower limb region, asymmetry of the lower limbs greater than 2 centimeters, previous surgeries in the lower limbs, limitation of range of motion in the joint (Impossible to perform muscle strength tests), use of antidepressive drugs or analgesics of continuous use, chronic diseases not controlled (Hypertension, rheumatoid arthritis and diabetes) and the presence of neuromuscular pathologies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact on Muscle Strength, Quality of Life and Functionality in Individuals Submitted to Hip Arthroplasty
Introduction: Total hip arthroplasty has been increasingly used as a means of treating the various pathologies of this joint. However, this surgical reconstruction initially brings important deficits in subjects submitted, such as: inhibition of muscle strength, limitation of range of motion and functional deficit. Therefore, an immediate physiotherapeutic treatment is necessary in the short and long term, taking into account both biomechanical issues and the quality of life of these individuals.
Objective: To evaluate the clinical evolution of individuals submitted to total hip arthroplasty in the ten year period.
Method: Twenty individuals submitted to unilateral total hip arthroplasty will be evaluated by the medical group of hip surgeries of the Brotherhood of Santa Casa de Misericórdia of São Paulo, during a period of ten years. These individuals will undergo a primary clinical evaluation and after signing the consent form, will be evaluated functionally with the HARRIS HIP SCORE and WHOQOL-bref questionnaires and physically with the analysis of muscular strength through manual dynamometry to measure the strength level of the Muscles involved in the bilateral coxo-femoral joint, such as abductors, adductors, flexors, extensors, internal rotators, external rotators, knee joint, such as extensors and flexors, and ankle, plantar flexors. Finally, they will be referred to the kinematic gait analysis, to identify the functional characteristics of these individuals, through reflexive markers at specific anatomical points, where they will walk for 5 minutes on a treadmill at a speed of 1.5km per hour.
- Conditions
- Arthroplasty Complications, Arthropathy of Hip
- Being tested
- Muscle Strenght assesment, 2D Kinematics Analysis
- Keywords
- Arthoplasty, Gait, muscle strenght, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Strenght assesmentDiagnostic test
Muscle Strenght assesment of the hip muscles
2D Kinematics AnalysisDiagnostic test
2D Kinematics Analysis of the gait
| Study group | Role | What they receive |
|---|---|---|
| Two Years Group | Not described Receives: Diagnostic Test: Muscle Strenght assesment; Diagnostic Test: 2D Kinematics Analysis | |
| Five Years Group | Not described Receives: Diagnostic Test: Muscle Strenght assesment; Diagnostic Test: 2D Kinematics Analysis | |
| Ten Years Group | Not described Receives: Diagnostic Test: Muscle Strenght assesment; Diagnostic Test: 2D Kinematics Analysis | |
| Control Group | Not described Receives: Diagnostic Test: Muscle Strenght assesment; Diagnostic Test: 2D Kinematics Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strenght
Hand-Held dynamometer (Lafayette)
Measured: Performed in a single evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start1 Jul 2016
- Primary completion1 Dec 2016
- Study completion4 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty ComplicationsStudies 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
- Cross-sectional
- Enrolment
- 65 participants (actual)
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, Claudio Cazarini Junior, Faculdade de Ciências Médicas da Santa Casa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079479
- Sponsor's protocol ID
- ccazarini
- Status last verified
- May 2016
- First submitted
- 8 Mar 2017
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Giannotti S, Bottai V, Dell'Osso G, De Paola G, Bugelli G, Guido G. The hip prosthesis in lateral femur fracture: current concepts and surgical technique. Clin Cases Miner Bone Metab. 2014 Sep;11(3):196-200.
PubMed 25568653Liu XW, Zi Y, Xiang LB, Wang Y. Total hip arthroplasty: areview of advances, advantages and limitations. Int J Clin Exp Med. 2015 Jan 15;8(1):27-36. eCollection 2015.
PubMed 25784971
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Muscle Strength, Quality of Life and Functionality in Individuals Submitted to Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03079479
- Acronym / sponsor ID
- ccazarini
- Conditions
- Arthroplasty Complications, Arthropathy of Hip
- Keywords
- Arthoplasty, Gait, muscle strenght, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 4 Jan 2018 (actual)
- First posted
- 14 Mar 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.
Introduction: Total hip arthroplasty has been increasingly used as a means of treating the various pathologies of this joint. However, this surgical reconstruction initially brings important deficits in subjects submitted, such as: inhibition of muscle strength, limitation of range of motion and functional deficit. Therefore, an immediate physiotherapeutic treatment is necessary in the short and long term, taking into account both biomechanical issues and the quality of life of these individuals.
Objective: To evaluate the clinical evolution of individuals submitted to total hip arthroplasty in the ten year period.
Method: Twenty individuals submitted to unilateral total hip arthroplasty will be evaluated by the medical group of hip surgeries of the Brotherhood of Santa Casa de Misericórdia of São Paulo, during a period of ten years. These individuals will undergo a primary clinical evaluation and after signing the consent form, will be evaluated functionally with the HARRIS HIP SCORE and WHOQOL-bref questionnaires and physically with the analysis of muscular strength through manual dynamometry to measure the strength level of the Muscles involved in the bilateral coxo-femoral joint, such as abductors, adductors, flexors, extensors, internal rotators, external rotators, knee joint, such as extensors and flexors, and ankle, plantar flexors. Finally, they will be referred to the kinematic gait analysis, to identify the functional characteristics of these individuals, through reflexive markers at specific anatomical points, where they will walk for 5 minutes on a treadmill at a speed of 1.5km per hour.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Two Years Group | – | Diagnostic Test: Muscle Strenght assesment, Diagnostic Test: 2D Kinematics Analysis |
| Five Years Group | – | Diagnostic Test: Muscle Strenght assesment, Diagnostic Test: 2D Kinematics Analysis |
| Ten Years Group | – | Diagnostic Test: Muscle Strenght assesment, Diagnostic Test: 2D Kinematics Analysis |
| Control Group | – | Diagnostic Test: Muscle Strenght assesment, Diagnostic Test: 2D Kinematics Analysis |
Who may qualify
- Ages
- 56 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with total hip arthroplasty through the postero lateral approach
Key inclusion criteria (1 listed)
- The inclusion criteria in the study will be: patients submitted to total hip arthroplasty between 2 years (24 months - 35 months), 5 years (60 months - 71 months) and 10 years (120 months - 131 months), age between 50 and 80 years and sign the terms of free and informed consent
Key exclusion criteria (1 listed)
- The exclusion criteria will be: patients with a history of prosthesis dislocations or revision of the arthroplasty, pain in the hip or lower limb region, asymmetry of the lower limbs greater than 2 centimeters, previous surgeries in the lower limbs, limitation of range of motion in the joint (Impossible to perform muscle strength tests), use of antidepressive drugs or analgesics of continuous use, chronic diseases not controlled (Hypertension, rheumatoid arthritis and diabetes) and the presence of neuromuscular pathologies
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 |
|---|---|---|
| Muscle Strenght assesmentMuscle Strenght assesment of the hip muscles | Diagnostic test | Control Group, Five Years Group, Ten Years Group, Two Years Group |
| 2D Kinematics Analysis2D Kinematics Analysis of the gait | Diagnostic test | Control Group, Five Years Group, Ten Years Group, Two Years Group |
Primary outcome
Muscle strenght
Time frame: Performed in a single evaluation
Hand-Held dynamometer (Lafayette)
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 27 Feb 2019.
- Background: PubMed 25568653Giannotti S, Bottai V, Dell'Osso G, De Paola G, Bugelli G, Guido G. The hip prosthesis in lateral femur fracture: current concepts and surgical technique. Clin Cases Miner Bone Metab. 2014 Sep;11(3):196-200.
- Results publication: PubMed 25784971Liu XW, Zi Y, Xiang LB, Wang Y. Total hip arthroplasty: areview of advances, advantages and limitations. Int J Clin Exp Med. 2015 Jan 15;8(1):27-36. eCollection 2015.
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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 Arthroplasty Complications and Arthropathy of Hip, 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 1 inclusion and 1 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 27 Feb 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 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?
Muscle strenght (time frame: Performed in a single evaluation). 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 NCT03079479, which also lists 2 linked publications.
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 27 Feb 2019.