OsteoarthritisNCT02883998
Formal vs. Home-Based Physical Therapy After Unicompartmental Knee Arthroplasty
A study testing Outpatient Physical Therapy and Home Base Physical Therapy in people with Osteoarthritis, run by Rush University Medical Center at 1 site in United States.
Trial summary
To determine whether home-based physical therapy (HBPT) is not clinically inferior to formal outpatient physical therapy (OPT) after hospital discharge of patients undergoing a unicompartmental knee arthroplasty (UKA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Outpatient Physical Therapy and Home Base Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Dec 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
- Scheduled for a unicompartmental knee arthroplasty
Who cannot join
- Require inpatient physical therapy beyond post-operative day one
- < 18 years old
- Decline to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Formal vs. Home-Based Physical Therapy After Unicompartmental Knee
To determine whether home-based physical therapy (HBPT) is not clinically inferior to formal outpatient physical therapy (OPT) after hospital discharge of patients undergoing a unicompartmental knee arthroplasty (UKA).
Read the detailed description
Given that current practice trends are requiring treatments to be both clinically and cost effective, research has begun to focus on evaluating the effect of specific interventions. Many surgeon and patients have believed formal OPT is necessary to optimize functional outcomes following orthopaedic procedures. However, the literature has begun to call into question the need for OPT following total hip arthroplasty, total knee arthroplasty, total shoulder arthroplasty, anterior cruciate ligament reconstruction, meniscectomy, and rotator cuff repair.
A randomized controlled trial was done to compare face-to-face rehabilitation with in-home telerehabilitation following total knee arthroplasty. Utilizing the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as the primary outcome, the authors demonstrated noninferiority of telerehabilitation compared to face-to-face rehabilitation. Other secondary outcomes of Knee Injury and Osteoarthritis Outcome Score (KOOS), range of motion, and isometric strength did not exhibit a difference between the treatment groups. (see citation below)
Based on these findings, it appears that the high cost of formal OPT doesn't translate into a meaningful improvement of functional outcome. Because patient's undergoing UKA have a higher pre-operative functional status than patients having a TKA (Total Knee Arthroplasty), it is reasonable to think that patients following a UKA are better equipped to succeed with HBPT. As a result, the hypothesis of the current study is that HBPT will prove to be non-inferior to formal OPT in the setting of UKA.
- Conditions
- Osteoarthritis
- Being tested
- Outpatient Physical Therapy, Home Base Physical Therapy
- Keywords
- home-based physical therapy, outpatient physical therapy, unicompartmental knee arthroplasty, PT (Physical Therapy), osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient Physical TherapyOther
traditional outpatient physical therapy which occurs at a physical therapy office
Home Base Physical TherapyOther
Patients will be provided a packet of exercises via a website which allows access to instructional physical therapy videos specifically designated for UKA patients and equipment to perform the home based physical therapy
| Study group | Role | What they receive |
|---|---|---|
| Outpatient Physical Therapy Group | Active comparator | Once the patient is cleared for discharged from the hospital, the patient will be given a prescription for outpatient physical therapy to attend 3 times per week for 6 weeks. Receives: Other: Outpatient Physical Therapy |
| Home Base Physical Therapy Group | Experimental | Patients will be provided a packet of exercises and equipment to perform the home based physical therapy program. Patients will attend a single session of outpatient physical therapy prior to surgery no more than 4 weeks prior to the procedure to teach the patient how to perform the exercises. Receives: Other: Home Base Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Knee Society Score
Measured: at 3 weeks, 3 months, and 1 year after surgery
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index
Measured: at 3 weeks, 3 months, and 1 year after surgery
Change from baseline in Knee range of motion
Measured: at 3 weeks, 3 months, and 1 year after surgery
Secondary outcomes (2)
Complications
Deep Vein Thrombosis or Pulmonary Embolus Return to the OR within 30 days Re-admission within 30 days Superficial infection Deep infection Periprosthetic fracture Knee stiffness (defined as < 90 degrees flexion at 3 weeks post-operative or < 110 degrees flexion at 6 weeks post-operative)
Measured: Will be assessed at 3 weeks, 3 months, and 1 year after surgery
Cost comparison
Measured: Will be assessed at 3 weeks, 3 months, and 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionMay 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rothman Institute Orthopaedics
- Responsible party
- Principal investigator, Craig J Della Valle, MD, Rush University Medical Center
- Investigators
- Craig Della Valle, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883998
- Sponsor's protocol ID
- 16021505
- Status last verified
- Jun 2018
- First submitted
- 22 Aug 2016
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Moffet H, Tousignant M, Nadeau S, Merette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile EL, Dimentberg R. In-Home Telerehabilitation Compared with Face-to-Face Rehabilitation After Total Knee Arthroplasty: A Noninferiority Randomized Controlled Trial. J Bone Joint Surg Am. 2015 Jul 15;97(14):1129-41. doi: 10.2106/JBJS.N.01066.
PubMed 26178888
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formal vs. Home-Based Physical Therapy After Unicompartmental Knee
- ClinicalTrials.gov ID
- NCT02883998
- Acronym / sponsor ID
- 16021505
- Conditions
- Osteoarthritis
- Keywords
- home-based physical therapy, outpatient physical therapy, unicompartmental knee arthroplasty, PT (Physical Therapy), osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Rothman Institute Orthopaedics
- Study start
- Aug 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 30 Aug 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.
To determine whether home-based physical therapy (HBPT) is not clinically inferior to formal outpatient physical therapy (OPT) after hospital discharge of patients undergoing a unicompartmental knee arthroplasty (UKA).
Detailed description
Given that current practice trends are requiring treatments to be both clinically and cost effective, research has begun to focus on evaluating the effect of specific interventions. Many surgeon and patients have believed formal OPT is necessary to optimize functional outcomes following orthopaedic procedures. However, the literature has begun to call into question the need for OPT following total hip arthroplasty, total knee arthroplasty, total shoulder arthroplasty, anterior cruciate ligament reconstruction, meniscectomy, and rotator cuff repair.
A randomized controlled trial was done to compare face-to-face rehabilitation with in-home telerehabilitation following total knee arthroplasty. Utilizing the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as the primary outcome, the authors demonstrated noninferiority of telerehabilitation compared to face-to-face rehabilitation. Other secondary outcomes of Knee Injury and Osteoarthritis Outcome Score (KOOS), range of motion, and isometric strength did not exhibit a difference between the treatment groups. (see citation below)
Based on these findings, it appears that the high cost of formal OPT doesn't translate into a meaningful improvement of functional outcome. Because patient's undergoing UKA have a higher pre-operative functional status than patients having a TKA (Total Knee Arthroplasty), it is reasonable to think that patients following a UKA are better equipped to succeed with HBPT. As a result, the hypothesis of the current study is that HBPT will prove to be non-inferior to formal OPT in the setting of UKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient Physical Therapy Group | Active comparator | Other: Outpatient Physical TherapyOnce the patient is cleared for discharged from the hospital, the patient will be given a prescription for outpatient physical therapy to attend 3 times per week for 6 weeks. |
| Home Base Physical Therapy Group | Experimental | Other: Home Base Physical TherapyPatients will be provided a packet of exercises and equipment to perform the home based physical therapy program. Patients will attend a single session of outpatient physical therapy prior to surgery no more than 4 weeks prior to the procedure to teach the patient how to perform the exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for a unicompartmental knee arthroplasty
Key exclusion criteria (3 listed)
- Require inpatient physical therapy beyond post-operative day one
- < 18 years old
- Decline to participate
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 Physical Therapytraditional outpatient physical therapy which occurs at a physical therapy office | Other | Outpatient Physical Therapy Group |
| Home Base Physical TherapyPatients will be provided a packet of exercises via a website which allows access to instructional physical therapy videos specifically designated for UKA patients and equipment to perform the home based physical therapy | Other | Home Base Physical Therapy Group |
Primary outcome
Change from baseline in Knee Society Score
Time frame: at 3 weeks, 3 months, and 1 year after surgery
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: at 3 weeks, 3 months, and 1 year after surgery
Change from baseline in Knee range of motion
Time frame: at 3 weeks, 3 months, and 1 year after surgery
2 secondary outcomes
Complications
Time frame: Will be assessed at 3 weeks, 3 months, and 1 year after surgery
Cost comparison
Time frame: Will be assessed at 3 weeks, 3 months, and 1 year after surgery
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 11 Jun 2018.
- Background: PubMed 26178888Moffet H, Tousignant M, Nadeau S, Merette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile EL, Dimentberg R. In-Home Telerehabilitation Compared with Face-to-Face Rehabilitation After Total Knee Arthroplasty: A Noninferiority Randomized Controlled Trial. J Bone Joint Surg Am. 2015 Jul 15;97(14):1129-41. doi: 10.2106/JBJS.N.01066.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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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.
Craig Della Valle, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient Physical Therapy and Home Base Physical Therapy in people with Osteoarthritis, run by Rush University Medical Center 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 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 11 Jun 2018. 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?
Change from baseline in Knee Society Score (time frame: at 3 weeks, 3 months, and 1 year after surgery). The study lists 3 primary outcomes in all. 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 NCT02883998, which also lists 1 linked publication.
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 11 Jun 2018.