Osteoarthritis of the HipNCT02279277
Physical Therapy Prior to Total Knee Replacement
A study testing Supervised physical therapy program prior to total knee replacement surgery in people with Osteoarthritis of the Hip, run by Rothman Institute Orthopaedics.
Trial summary
In this study, the investigators are investigating the effects of physical therapy (PT) for treating high grade knee osteoarthritis (OA) in patients that are candidates for total knee replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of the Hip
- What is being tested?
- Supervised physical therapy program prior to total knee replacement surgery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee osteoarthritis (Kellgren-Lawrence grade 3 or 4) confirmed via standing AP radiograph
- Surgical candidate for TKA, having had a least a 3 months of pain affecting ADL's unresponsive to conservative treatment consisting of AT LEAST one non-narcotic medication AND one injection (corticosteroid or series of viscosupplementation). Injection must not have been administered within 6 weeks of start of PT trial
- Prior knee surgery from arthroscopies, meniscal surgery and ligament reconstruction
Who cannot join
- Anyone who received physical therapy in the last 6 months
- Inability to walk unaided for >1 block
- Currently engaged in regular PT or a regular home exercise program
- Prior knee arthroplasty
- Prior knee surgery for trauma, tumor and osteotomy
- Injection given within 6 weeks of starting therapy
- Patients using daily narcotic medications within prior 6 weeks
About this study
Official title: Effect of Physical Therapy on Grade 3 or 4 Knee Osteoarthritis
In this study, the investigators are investigating the effects of physical therapy (PT) for treating high grade knee osteoarthritis (OA) in patients that are candidates for total knee replacement. Through the examination of patient outcomes, such as pain, stiffness, and physical function, the investigators will determine if PT prior to total knee replacement is an effective treatment in a patient with high grade OA.
- Conditions
- Osteoarthritis of the Hip
- Being tested
- Supervised physical therapy program prior to total knee replacement surgery
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised physical therapy program prior to total knee replacement surgeryBehavioural
| Study group | Role | What they receive |
|---|---|---|
| No physical therapy | No intervention | No prescribed, supervised physical therapy prior to total knee replacement |
| Physical Therapy | Active comparator | Prescribed, supervised physical therapy prior to total knee replacement Receives: Behavioral: Supervised physical therapy program prior to total knee replacement surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion following Total Knee Replacement
Measured: 6 weeks
Secondary outcomes (2)
Patient reported perception of pain following total knee replacement
Measured: 6 weeks
Return to functional activities following total knee replacement
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the HipStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279277
- Sponsor's protocol ID
- Austin2014
- Status last verified
- Oct 2014
- First submitted
- 6 Oct 2014
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Therapy on Grade 3 or 4 Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02279277
- Acronym / sponsor ID
- Austin2014
- Conditions
- Osteoarthritis of the Hip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- First posted
- 31 Oct 2014 (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.
In this study, the investigators are investigating the effects of physical therapy (PT) for treating high grade knee osteoarthritis (OA) in patients that are candidates for total knee replacement. Through the examination of patient outcomes, such as pain, stiffness, and physical function, the investigators will determine if PT prior to total knee replacement is an effective treatment in a patient with high grade OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No physical therapy | No intervention | –No prescribed, supervised physical therapy prior to total knee replacement |
| Physical Therapy | Active comparator | Behavioral: Supervised physical therapy program prior to total knee replacement surgeryPrescribed, supervised physical therapy prior to total knee replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Knee osteoarthritis (Kellgren-Lawrence grade 3 or 4) confirmed via standing AP radiograph
- Surgical candidate for TKA, having had a least a 3 months of pain affecting ADL's unresponsive to conservative treatment consisting of AT LEAST one non-narcotic medication AND one injection (corticosteroid or series of viscosupplementation). Injection must not have been administered within 6 weeks of start of PT trial
- Prior knee surgery from arthroscopies, meniscal surgery and ligament reconstruction
Key exclusion criteria (7 listed)
- Anyone who received physical therapy in the last 6 months
- Inability to walk unaided for >1 block
- Currently engaged in regular PT or a regular home exercise program
- Prior knee arthroplasty
- Prior knee surgery for trauma, tumor and osteotomy
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 |
|---|---|---|
| Supervised physical therapy program prior to total knee replacement surgery | Behavioural | Physical Therapy |
Primary outcome
Range of Motion following Total Knee Replacement
Time frame: 6 weeks
2 secondary outcomes
Patient reported perception of pain following total knee replacement
Time frame: 6 weeks
Return to functional activities following total knee replacement
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
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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 Supervised physical therapy program prior to total knee replacement surgery in people with Osteoarthritis of the Hip, 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 3 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: status not confirmed, as of the sponsor's last update on 31 Oct 2014. 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?
Results are not available in the source record.
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?
Range of Motion following Total Knee Replacement (time frame: 6 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 31 Oct 2014.