ArthritisNCT00175448
Comparison of Physiotherapy Versus Home Exercise Following Hip Replacement Surgery
A study testing physiotherapy in people with Arthritis and Arthroscopic Hip Surgery, run by University of British Columbia.
Trial summary
A Randomized Controlled Trial of Outpatient Physiotherapy versus a Self-Administered Home Exercise Program Following Discharge Home from Total Hip Arthroplasty Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthritis, Arthroscopic Hip Surgery
- What is being tested?
- physiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Dec 2007
- 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 Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- primary THA (cemented or cementless)
- preoperative diagnosis of osteoarthritis (primary or secondary)
- meets objective discharge-to-home test following hip replacement
- ability to speak English and reply to questionnaires written in English
- ability to provide informed consent
- may include patients presenting for their second primary hip arthroplasty
Show all 12Show fewer
- Discharge to Home Criteria
- independent supine-to-sit transfer
- independent sit-to-stand transfer
- walk with walking aid 30 meters
- ascend and descend 3 stairs
- deemed medically fit and safe for home environment by surgeon/nursing/PT
Who cannot join
- surgery as part of a workers' compensation claim
- arthroplasty performed for trauma or following open reduction and internal fixation, malignancy or inflammatory arthropathy
- intra-operative complication of fracture or sciatic nerve injury
- procedure requiring complex surgical approach other than posterior or anterolateral (ie trochanteric osteotomy/micro 2 incision approach)
- indications for additional primary or revision arthroplasty within the time frame of the study (24 months) in other hip or knee joints which would adversely affect quality of life and functional scores pertaining to the joint of interest
About this study
Official title: A Randomized Controlled Trial of Outpatient Physiotherapy Versus a Self-Administered Home Exercise Program Following Discharge Home From Total Hip Arthroplasty
A Randomized Controlled Trial of Outpatient Physiotherapy versus a Self-Administered Home Exercise Program Following Discharge Home from Total Hip Arthroplasty
- Conditions
- Arthritis, Arthroscopic Hip Surgery
- Being tested
- physiotherapy
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapyProcedure or surgery
See Detailed Description.
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function at 16 weeks post THA in patients who received outpatient physiotherapy following discharge home compared to unsupervised self- directed exercises alone (as measured by the WOMAC).
Measured: 16 weeks
Secondary outcomes (10)
Does outpatient physiotherapy result in superior outcomes (final outcome) at 1 and 2 years post THA?
Measured: 2 years
Does outpatient physiotherapy, compared to a self-directed exercise program, result in greater improvement in:
generic health-related QOL (SF-36) and (HUI3)
pain and stiffness (WOMAC pain and stiffness)
activities of daily living (FSI)
patient satisfaction (Brigham and Women's patient satisfaction)
objective physical function (TUG, Harris Hip, Gait Lab)
What is the marginal cost effectiveness of outpatient physiotherapy versus self-directed exercises?
How does the recovery over time compare between programs (trajectory of recovery) ?
What is the difference in musculoskeletal adverse event rate (ie dislocation)?
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Nelson Greidanus, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175448
- Sponsor's protocol ID
- C02-0249
- Status last verified
- Sep 2005
- First submitted
- 11 Sep 2005
- Last updated
- 25 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Outpatient Physiotherapy Versus a Self-Administered Home Exercise Program Following Discharge Home From Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00175448
- Acronym / sponsor ID
- C02-0249
- Conditions
- Arthritis, Arthroscopic Hip Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Sep 2005 (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.
A Randomized Controlled Trial of Outpatient Physiotherapy versus a Self-Administered Home Exercise Program Following Discharge Home from Total Hip Arthroplasty
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- primary THA (cemented or cementless)
- preoperative diagnosis of osteoarthritis (primary or secondary)
- meets objective discharge-to-home test following hip replacement
- ability to speak English and reply to questionnaires written in English
- ability to provide informed consent
Key exclusion criteria (5 listed)
- surgery as part of a workers' compensation claim
- arthroplasty performed for trauma or following open reduction and internal fixation, malignancy or inflammatory arthropathy
- intra-operative complication of fracture or sciatic nerve injury
- procedure requiring complex surgical approach other than posterior or anterolateral (ie trochanteric osteotomy/micro 2 incision approach)
- indications for additional primary or revision arthroplasty within the time frame of the study (24 months) in other hip or knee joints which would adversely affect quality of life and functional scores pertaining to the joint of interest
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 |
|---|---|---|
| physiotherapySee Detailed Description. | Procedure or surgery | – |
Primary outcome
Physical function at 16 weeks post THA in patients who received outpatient physiotherapy following discharge home compared to unsupervised self- directed exercises alone (as measured by the WOMAC).
Time frame: 16 weeks
10 secondary outcomes
Does outpatient physiotherapy result in superior outcomes (final outcome) at 1 and 2 years post THA?
Time frame: 2 years
Does outpatient physiotherapy, compared to a self-directed exercise program, result in greater improvement in:
generic health-related QOL (SF-36) and (HUI3)
pain and stiffness (WOMAC pain and stiffness)
activities of daily living (FSI)
patient satisfaction (Brigham and Women's patient satisfaction)
objective physical function (TUG, Harris Hip, Gait Lab)
What is the marginal cost effectiveness of outpatient physiotherapy versus self-directed exercises?
How does the recovery over time compare between programs (trajectory of recovery) ?
What is the difference in musculoskeletal adverse event rate (ie dislocation)?
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 25 Sep 2008.
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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.
Nelson Greidanus, MD principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study testing physiotherapy in people with Arthritis and Arthroscopic Hip Surgery, run by University of British Columbia.
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 12 inclusion and 5 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 25 Sep 2008. 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?
Physical function at 16 weeks post THA in patients who received outpatient physiotherapy following discharge home compared to unsupervised self- directed exercises alone (as measured by the WOMAC). (time frame: 16 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 25 Sep 2008.