Osteoarthritis, HipArtrhosisNCT01491048
Evaluation of Functional Rehabilitation in Patients Undergoing Physiotherapy After Total Hip Arthroplasty
A study testing THA Physiotherapy and No physiotherapy after THA in people with Osteoarthritis, Hip, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
This study aims to objectively evaluate the implications of physiotherapeutic rehabilitation in the Assistance Protocol of Total Hip Arthroplasty (THA), by assessing the motor performance and testing the quality of life of patients undergoing THA surgery, to improve rehabilitation strategies for this population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- THA Physiotherapy and No physiotherapy after THA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2009to Oct 2011
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with indication for THA.
Who cannot join
- Patients who refuse to participate in this study.
- Patients who live outside the city of Porto Alegre, due to difficulties for visits and the protocol monitoring.
- Patients with femoral neck fracture, due to the impossibility of evaluation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Evaluation of Functional Rehabilitation Therapy in Patients Undergoing Physiotherapy After Total Hip Arthroplasty
This study aims to objectively evaluate the implications of physiotherapeutic rehabilitation in the Assistance Protocol of Total Hip Arthroplasty (THA), by assessing the motor performance and testing the quality of life of patients undergoing THA surgery, to improve rehabilitation strategies for this population.
Read the detailed description
The Total Hip Arthroplasty (THA) is a surgical procedure which has been used for more than half a century in the treatment of hip joint diseases.
The Physiotherapy is an important component in the care of patients undergoing THA.
In order to reduce the length of hospitalization after THA, to promote functional independence and to monitor clinical events during hospitalization and up to the 30th postoperative day, the Hip Surgery Group (HSG) of the Department of Orthopedics and Traumatology Department of Orthopedics and Traumatology of Hospital de Clinicas de Porto Alegre (HCPA) has developed a global, multidisciplinary Assistance Protocol of the HSG with outpatient consultations and scheduled home visits for patients that have undergone THA at HCPA.
The team which developed the Assistance Protocol of the HSG consists of orthopedic doctors and anesthesiologists, nurses and social workers.
The insertion of the Physiotherapist in the THA Assistance Protocol is of great importance owing to the professional skills of that professional in the areas of prevention and rehabilitation, working with the multidisciplinary team in functional evaluation and in physical therapy of patients that underwent THA.
The monitoring of the physiotherapist is essential to establish a functional diagnosis, aiming pain relief, promoting the early functional rehabilitation, the reintegration of the patients in their daily activities and offering a better quality of life through reintegration into social life.
- Conditions
- Osteoarthritis, Hip
- Being tested
- THA Physiotherapy, No physiotherapy after THA
- Keywords
- Hip osteoarthritis, Physiotherapy, THA
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THA PhysiotherapyProcedure or surgery
Also called osteoarthrosis, hip, physiotherapy.
Patients will be randomized into two groups. The control group will receive care from the team of the THA Assistance Protocol already used by the HSG of HCPA without the intervention of physiotherapy. During hospitalization, the group of cases will be submitted to physical therapy associated with the intervention of the team of the THA Assistance Protocol.
No physiotherapy after THAProcedure or surgery
Also called Physiotherapy, THA
No physiotherapy after THA
| Study group | Role | What they receive |
|---|---|---|
| THA Physiotherapy | Active comparator | Physiotherapy care during the period of hospitalization after THA. Receives: Procedure: THA Physiotherapy; Procedure: No physiotherapy after THA |
| No physiotherapy after THA | Active comparator | No Physiotherapy care during the period of hospitalization after THA. Receives: Procedure: No physiotherapy after THA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiotherapeutic Rehabilitation after THA.
Patients hospitalized in the HCPA for THA surgery, are submitted to an assessment and are randomized. Soon after, the treatment group receives the physiotherapy protocol while the control group receives guidance together with the THA Assistance Protocol. Fifteen days later the patients return to hospital where they are reassessed.
Measured: 15 days after discharge
Secondary outcomes (1)
Physiotherapeutic Rehabilitation after THA.
Patients will be evaluated through tests of strength, range of motion, limb discrepancy, hip functionality and quality of life before and after discharge.
Measured: 15 days after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startJul 2009
- Primary completionOct 2011
- Study completionOct 2011
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 Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Sant'Anna Umpierres, Hospital de Clinicas de Porto Alegre
- Investigators
- Carolina S Umpierres, Bachelor, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491048
- Sponsor's protocol ID
- 09242
- Acronym
- Artrhosis
- Status last verified
- Dec 2011
- First submitted
- 30 Oct 2011
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Walker RL, Fromm PO. Metabolism of iron by normal and iron deficient rainbow trout. Comp Biochem Physiol A Comp Physiol. 1976;55(4A):311-8. doi: 10.1016/0300-9629(76)90052-9. No abstract available.
PubMed 9242Umpierres CS, Ribeiro TA, Marchisio AE, Galvao L, Borges IN, Macedo CA, Galia CR. Rehabilitation following total hip arthroplasty evaluation over short follow-up time: randomized clinical trial. J Rehabil Res Dev. 2014;51(10):1567-78. doi: 10.1682/JRRD.2014.05.0132.
PubMed 25856757
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functional Rehabilitation Therapy in Patients Undergoing Physiotherapy After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01491048
- Acronym / sponsor ID
- Artrhosis / 09242
- Conditions
- Osteoarthritis, Hip
- Keywords
- Hip osteoarthritis, Physiotherapy, THA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 13 Dec 2011 (estimated)
- 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 study aims to objectively evaluate the implications of physiotherapeutic rehabilitation in the Assistance Protocol of Total Hip Arthroplasty (THA), by assessing the motor performance and testing the quality of life of patients undergoing THA surgery, to improve rehabilitation strategies for this population.
Detailed description
The Total Hip Arthroplasty (THA) is a surgical procedure which has been used for more than half a century in the treatment of hip joint diseases.
The Physiotherapy is an important component in the care of patients undergoing THA.
In order to reduce the length of hospitalization after THA, to promote functional independence and to monitor clinical events during hospitalization and up to the 30th postoperative day, the Hip Surgery Group (HSG) of the Department of Orthopedics and Traumatology Department of Orthopedics and Traumatology of Hospital de Clinicas de Porto Alegre (HCPA) has developed a global, multidisciplinary Assistance Protocol of the HSG with outpatient consultations and scheduled home visits for patients that have undergone THA at HCPA.
The team which developed the Assistance Protocol of the HSG consists of orthopedic doctors and anesthesiologists, nurses and social workers.
The insertion of the Physiotherapist in the THA Assistance Protocol is of great importance owing to the professional skills of that professional in the areas of prevention and rehabilitation, working with the multidisciplinary team in functional evaluation and in physical therapy of patients that underwent THA.
The monitoring of the physiotherapist is essential to establish a functional diagnosis, aiming pain relief, promoting the early functional rehabilitation, the reintegration of the patients in their daily activities and offering a better quality of life through reintegration into social life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THA Physiotherapy | Active comparator | Procedure: THA Physiotherapy, Procedure: No physiotherapy after THAPhysiotherapy care during the period of hospitalization after THA. |
| No physiotherapy after THA | Active comparator | Procedure: No physiotherapy after THANo Physiotherapy care during the period of hospitalization after THA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with indication for THA.
Key exclusion criteria (3 listed)
- Patients who refuse to participate in this study.
- Patients who live outside the city of Porto Alegre, due to difficulties for visits and the protocol monitoring.
- Patients with femoral neck fracture, due to the impossibility of evaluation.
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 |
|---|---|---|
| THA PhysiotherapyAlso: osteoarthrosis, hip, physiotherapy.Patients will be randomized into two groups. The control group will receive care from the team of the THA Assistance Protocol already used by the HSG of HCPA without the intervention of physiotherapy. During hospitalization, the group of cases will be submitted to physical therapy associated with the intervention of the team of the THA Assistance Protocol. | Procedure or surgery | THA Physiotherapy |
| No physiotherapy after THAAlso: Physiotherapy, THANo physiotherapy after THA | Procedure or surgery | No physiotherapy after THA, THA Physiotherapy |
Primary outcome
Physiotherapeutic Rehabilitation after THA.
Time frame: 15 days after discharge
Patients hospitalized in the HCPA for THA surgery, are submitted to an assessment and are randomized. Soon after, the treatment group receives the physiotherapy protocol while the control group receives guidance together with the THA Assistance Protocol. Fifteen days later the patients return to hospital where they are reassessed.
1 secondary outcome
Physiotherapeutic Rehabilitation after THA.
Time frame: 15 days after discharge.
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 13 Dec 2011.
- Background: PubMed 9242Walker RL, Fromm PO. Metabolism of iron by normal and iron deficient rainbow trout. Comp Biochem Physiol A Comp Physiol. 1976;55(4A):311-8. doi: 10.1016/0300-9629(76)90052-9. No abstract available.
- Derived from this study: PubMed 25856757Umpierres CS, Ribeiro TA, Marchisio AE, Galvao L, Borges IN, Macedo CA, Galia CR. Rehabilitation following total hip arthroplasty evaluation over short follow-up time: randomized clinical trial. J Rehabil Res Dev. 2014;51(10):1567-78. doi: 10.1682/JRRD.2014.05.0132.
Related trials for Osteoarthritis, Hip
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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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
Recruiting
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.
Carolina S Umpierres, Bachelor principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THA Physiotherapy and No physiotherapy after THA in people with Osteoarthritis, Hip, run by Hospital de Clinicas de Porto Alegre 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 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: finished, as of the sponsor's last update on 13 Dec 2011. 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?
Physiotherapeutic Rehabilitation after THA. (time frame: 15 days after discharge). 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 NCT01491048, 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 13 Dec 2011.