OsteoarthritisNCT02687945
PT vs no PT Following THA
A study testing Outpatient physiotherapy and Self-guided physiotherapy in people with Osteoarthritis, run by Rothman Institute Orthopaedics.
Trial summary
The purpose of this study is to determine if outpatient physiotherapy results in improved and/or more rapid achievement of functional outcomes and quality of life in comparison to those patients who do not undergo outpatient physiotherapy after total hip arthroplasty Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Outpatient physiotherapy and Self-guided physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- May 2015to Mar 2016
- 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 60 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Any patient undergoing unilateral primary total hip arthroplasty with age > 60
Who cannot join
- Post-traumatic osteoarthritis
- Rheumatoid arthritis or other peripheral inflammatory disease
- Avascular necrosis
- Revision or conversion THA
- Post-septic osteoarthritis
- Patients discharged to a rehabilitation unit or other form of respite care such as a skilled nursing facility, acute rehabilitation center, convalescent home, long-term care facility or nursing home
About this study
Official title: Study to Evaluate Outpatient Physiotherapy in Total Hip Arthroplasty: A Prospective Randomized Controlled Trial
The purpose of this study is to determine if outpatient physiotherapy results in improved and/or more rapid achievement of functional outcomes and quality of life in comparison to those patients who do not undergo outpatient physiotherapy after total hip arthroplasty
- Conditions
- Osteoarthritis
- Being tested
- Outpatient physiotherapy, Self-guided physiotherapy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient physiotherapyProcedure or surgery
Self-guided physiotherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Outpatient physiotherapy | Active comparator | two weeks of in-home physiotherapy following total hip replacement followed by two months of outpatient physiotherapy with 2-3 weekly sessions Receives: Procedure: Outpatient physiotherapy |
| No outpatient physiotherapy | Active comparator | two weeks of in-home physiotherapy following total hip replacement followed by two months of self-guided physiotherapy exercises Receives: Procedure: Self-guided physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
This is a validated instrument
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startMay 2015
- Primary completionSep 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687945
- Sponsor's protocol ID
- 2016MAus
- Status last verified
- Mar 2016
- First submitted
- 17 Feb 2016
- Last updated
- 15 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate Outpatient Physiotherapy in Total Hip Arthroplasty: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02687945
- Acronym / sponsor ID
- 2016MAus
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 Feb 2016 (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.
The purpose of this study is to determine if outpatient physiotherapy results in improved and/or more rapid achievement of functional outcomes and quality of life in comparison to those patients who do not undergo outpatient physiotherapy after total hip arthroplasty
Study design
- Primary purpose
- Supportive care
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient physiotherapy | Active comparator | Procedure: Outpatient physiotherapytwo weeks of in-home physiotherapy following total hip replacement followed by two months of outpatient physiotherapy with 2-3 weekly sessions |
| No outpatient physiotherapy | Active comparator | Procedure: Self-guided physiotherapytwo weeks of in-home physiotherapy following total hip replacement followed by two months of self-guided physiotherapy exercises |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient undergoing unilateral primary total hip arthroplasty with age > 60
Key exclusion criteria (6 listed)
- Post-traumatic osteoarthritis
- Rheumatoid arthritis or other peripheral inflammatory disease
- Avascular necrosis
- Revision or conversion THA
- Post-septic osteoarthritis
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 |
|---|---|---|
| Outpatient physiotherapy | Procedure or surgery | Outpatient physiotherapy |
| Self-guided physiotherapy | Procedure or surgery | No outpatient physiotherapy |
Primary outcome
Harris Hip Score
Time frame: 4 weeks
This is a validated instrument
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 15 Mar 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient physiotherapy and Self-guided physiotherapy in people with Osteoarthritis, run by Rothman Institute Orthopaedics.
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 6 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 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Harris Hip Score (time frame: 4 weeks). 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 15 Mar 2016.