Knee OsteoarthritisNCT02377102
Does Physical Therapy Prevent Total Knee Arthroplasty in Patients With End Stage Osteoarthritis
A study testing Physical Therapy in people with Knee Osteoarthritis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: For the target population of adult patients with end stage osteoarthritis, this randomized clinical trial will be used to evaluate the benefit of three months of physical therapy compared to no treatment in patients indicated for total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Physical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Oct 2017
- 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
- Adult patients with grade 3 and 4 (severe) osteoarthritis and indicated for primary total knee arthroplasty.
Who cannot join
- Age less than 18 y/o
- Any form of arthritis other than osteoarthritis (traumatic, rheumatic, etc)
- Previous knee surgery
- Inability to personally consent to or participate with therapy due to cognitive impairment, physical disability, intoxication or sedation
- known contraindications would include patients that will be unable to participate with therapy or who will put themselves at significant risk due to therapy (this could be either severe cardiac or respiratory impairment that prevents the patient from ambulating or mental impairment preventing the patients from following instructions
Trial locations and contacts
1 site in 1 country.
About this study
Purpose: For the target population of adult patients with end stage osteoarthritis, this randomized clinical trial will be used to evaluate the benefit of three months of physical therapy compared to no treatment in patients indicated for total knee arthroplasty.
Participants:Patients that are diagnosed with end stage osteoarthritis who are indicated for total knee arthroplasty.
Procedures: Patients will be randomized to either receive physical therapy or no treatment. They will be scheduled to return in 3 months for discussion of operative versus continued nonoperative treatment of their osteoarthritis.This will be determined by change in PROMIS (Patient Reported Outcome Measurement Information System) score and prevention of surgery.
- Conditions
- Knee Osteoarthritis
- Being tested
- Physical Therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyProcedure or surgery
12 weeks of supervised physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Observational | No intervention | Patients will be asked to continue for 12 weeks of nonoperative medical management without physical therapy. At 12 weeks they will be reevaluated regarding the need for total knee arthroplasty. |
| Physical Therapy | Active comparator | Patients will be provided a prescription for 12 weeks of physical therapy at a location of their choice. No set protocol will be issued to allow for adjustments based on patient activity level and the therapist's professional choice. The physical therapy techniques, consisting of active and passive physiological and accessory movements and soft tissue mobilization, active range of motion exercises, muscle strengthening, muscle stretching, and exercises such as riding a stationary bicycle will be applied at the discretion of the treating physical therapist primarily to the knee and surrounding structures. Receives: Procedure: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of surgical intervention questionnaire
Following Physical Therapy or observation, the patients (who are indicated for total knee replacement) will be asked if they desire a surgical intervention or if they would like to continue nonoperative management.
Measured: 12 weeks
Secondary outcomes (1)
PROMIS-(Patient Reported Outcomes Measurement Information System) Lower Extremity Function Score
The PROMIS score incorporates questions from multiple validated instruments of functional outcome. The system was then calibrated to the normal population distribution and has been applied previously to assess lower extremity dysfunction. This will increase our sensitivity in detecting differences between the two groups. The CAT is an adaptive test that responds to previous patient responses to decrease the amount of questions required to obtain a score. This will allow our CAT to last 1-5 minutes as opposed to a longer patient reported score or system. PROMIS has also been utilized in the setting of arthritis and should allow for a greater detection of functional improvement.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel J Del Gaizo, MD, Study director, UNC Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377102
- Sponsor's protocol ID
- 14-2152
- Status last verified
- Oct 2017
- First submitted
- 25 Feb 2015
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Physical Therapy Prevent Total Knee Arthroplasty in Patients With End Stage Osteoarthritis
- ClinicalTrials.gov ID
- NCT02377102
- Acronym / sponsor ID
- 14-2152
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 3 Mar 2015 (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.
Purpose: For the target population of adult patients with end stage osteoarthritis, this randomized clinical trial will be used to evaluate the benefit of three months of physical therapy compared to no treatment in patients indicated for total knee arthroplasty.
Participants:Patients that are diagnosed with end stage osteoarthritis who are indicated for total knee arthroplasty.
Procedures: Patients will be randomized to either receive physical therapy or no treatment. They will be scheduled to return in 3 months for discussion of operative versus continued nonoperative treatment of their osteoarthritis.This will be determined by change in PROMIS (Patient Reported Outcome Measurement Information System) score and prevention of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational | No intervention | –Patients will be asked to continue for 12 weeks of nonoperative medical management without physical therapy. At 12 weeks they will be reevaluated regarding the need for total knee arthroplasty. |
| Physical Therapy | Active comparator | Procedure: Physical TherapyPatients will be provided a prescription for 12 weeks of physical therapy at a location of their choice. No set protocol will be issued to allow for adjustments based on patient activity level and the therapist's professional choice. The physical therapy techniques, consisting of active and passive physiological and accessory movements and soft tissue mobilization, active range of motion exercises, muscle strengthening, muscle stretching, and exercises such as riding a stationary bicycle will be applied at the discretion of the treating physical therapist primarily to the knee and surrounding structures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with grade 3 and 4 (severe) osteoarthritis and indicated for primary total knee arthroplasty.
Key exclusion criteria (5 listed)
- Age less than 18 y/o
- Any form of arthritis other than osteoarthritis (traumatic, rheumatic, etc)
- Previous knee surgery
- Inability to personally consent to or participate with therapy due to cognitive impairment, physical disability, intoxication or sedation
- known contraindications would include patients that will be unable to participate with therapy or who will put themselves at significant risk due to therapy (this could be either severe cardiac or respiratory impairment that prevents the patient from ambulating or mental impairment preventing the patients from following instructions
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 |
|---|---|---|
| Physical Therapy12 weeks of supervised physical therapy. | Procedure or surgery | Physical Therapy |
Primary outcome
Prevention of surgical intervention questionnaire
Time frame: 12 weeks
Following Physical Therapy or observation, the patients (who are indicated for total knee replacement) will be asked if they desire a surgical intervention or if they would like to continue nonoperative management.
1 secondary outcome
PROMIS-(Patient Reported Outcomes Measurement Information System) Lower Extremity Function Score
Time frame: 12 weeks
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 14 Nov 2017.
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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.
Daniel J Del Gaizo, MD study director
UNC Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy in people with Knee Osteoarthritis, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 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 14 Nov 2017. 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 United States. 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?
Prevention of surgical intervention questionnaire (time frame: 12 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 14 Nov 2017.