OsteoarthritisLRUNCT01814033
Use of the LRU Pillow in the Acute Setting Following Total Knee Arthroplasty
A study testing Experimental: LRU Pillow in people with Osteoarthritis, run by Newton-Wellesley Hospital at 1 site in United States.
Trial summary
The Null Hypothesis is that there is no significant change in range of motion (ROM), pain, or function for a group of patients following total knee arthroplasty (TKA) who use the LRU pillow as compared to a control group of total knee arthroplasty patients who do not use the pillow. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Experimental: LRU Pillow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary total knee arthroplasty patients with primary diagnosis of osteoarthritis.
Who cannot join
- bilateral total knee arthroplasties
- revision total knee arthroplasties
- unexpected decline in medical or mental status
- Subjects will range from 30 years of age to 80 years of age
- primary diagnosis of rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
United States1 site
Newton Wellesley Hospital
Newton, Massachusetts, 02462
Hope M Violette, BS, 617-243-6493, hviolette1@partners.org
Theresa J Gustus, PT, MS, DPT, 617-243-6885, tgustus@partners.org
About this study
The Null Hypothesis is that there is no significant change in range of motion (ROM), pain, or function for a group of patients following total knee arthroplasty (TKA) who use the LRU pillow as compared to a control group of total knee arthroplasty patients who do not use the pillow.
Read the detailed description
- Study design will be a Pretest-Posttest Control Group Design . Enrollment would be random assignment of 20 patients to a control group vs 20 patients to a treatment group for patients with the diagnosis of osteoarthritis (OA) of the knee admitted for primary total knee arthroplasty. For specifics of patient assignment, please see below under Recruitment Procedures.
- Unpaired t-Tests will be used to determine differences between mean scores for the dependent variables (pain, range of motion, functional mobility). Analysis of Covariance will be run to quantify the effect of the co-variates of age, gender, body mass index (BMI), and contralateral previous TKA. Confidence Intervals will be set at 95%.
- Conditions
- Osteoarthritis
- Being tested
- Experimental: LRU Pillow, Control Group
- Keywords
- LRU, Total Knee Arthroplasty, Total Knee Replacement, Acute Rehabilitation Total Knee, Total Knee Range of Motion, Total Knee Acute care Outcomes
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: LRU PillowOther
Foam wedge with a trough for positioning of the lower leg in an elevated position.
Control GroupOther
Standard bed pillows placed under the lower leg to facilitate elevation
| Study group | Role | What they receive |
|---|---|---|
| LRU Pillow | Experimental | Experimental: LRU Pillow Receives: Other: Experimental: LRU Pillow |
| Control Group | Active comparator | Other: Control Group Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
Knee ROM measured both actively and passively with a standard long arm goniometer twice daily for both groups.
Measured: 3 Days
Secondary outcomes (1)
Pain
Pain will be assessed using a visual analogue scale twice daily both at rest and with activity (exercise).
Measured: 3 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startNov 2015
- Primary completionFeb 2016 (estimated)
- Study completionMar 2016 (estimated)
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.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newton-Wellesley Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theresa J. Gustus, Newton-Wellesley Hospital
- Investigators
- Theresa J Gustus, PT, DPT, MS, Principal investigator, Newton-Wellesley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814033
- Sponsor's protocol ID
- LRU1
- Acronym
- LRU
- Status last verified
- Oct 2015
- First submitted
- 15 Mar 2013
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Khanasuk Y, Ngarmukos S. Contemporary pain management in total knee arthroplasty. J Med Assoc Thai. 2012 Oct;95 Suppl 10:S238-44.
PubMed 23451469
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the LRU Pillow in the Acute Setting Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01814033
- Acronym / sponsor ID
- LRU / LRU1
- Conditions
- Osteoarthritis
- Keywords
- LRU, Total Knee Arthroplasty, Total Knee Replacement, Acute Rehabilitation Total Knee, Total Knee Range of Motion, Total Knee Acute care Outcomes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Newton-Wellesley HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 19 Mar 2013 (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 Null Hypothesis is that there is no significant change in range of motion (ROM), pain, or function for a group of patients following total knee arthroplasty (TKA) who use the LRU pillow as compared to a control group of total knee arthroplasty patients who do not use the pillow.
Detailed description
- Study design will be a Pretest-Posttest Control Group Design . Enrollment would be random assignment of 20 patients to a control group vs 20 patients to a treatment group for patients with the diagnosis of osteoarthritis (OA) of the knee admitted for primary total knee arthroplasty. For specifics of patient assignment, please see below under Recruitment Procedures.
- Unpaired t-Tests will be used to determine differences between mean scores for the dependent variables (pain, range of motion, functional mobility). Analysis of Covariance will be run to quantify the effect of the co-variates of age, gender, body mass index (BMI), and contralateral previous TKA. Confidence Intervals will be set at 95%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LRU Pillow | Experimental | Other: Experimental: LRU PillowExperimental: LRU Pillow |
| Control Group | Active comparator | Other: Control GroupOther: Control Group |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary total knee arthroplasty patients with primary diagnosis of osteoarthritis.
Key exclusion criteria (5 listed)
- bilateral total knee arthroplasties
- revision total knee arthroplasties
- unexpected decline in medical or mental status
- Subjects will range from 30 years of age to 80 years of age
- primary diagnosis of rheumatoid arthritis
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 |
|---|---|---|
| Experimental: LRU PillowFoam wedge with a trough for positioning of the lower leg in an elevated position. | Other | LRU Pillow |
| Control GroupStandard bed pillows placed under the lower leg to facilitate elevation | Other | Control Group |
Primary outcome
Range of Motion
Time frame: 3 Days
Knee ROM measured both actively and passively with a standard long arm goniometer twice daily for both groups.
1 secondary outcome
Pain
Time frame: 3 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
- Background: PubMed 23451469Khanasuk Y, Ngarmukos S. Contemporary pain management in total knee arthroplasty. J Med Assoc Thai. 2012 Oct;95 Suppl 10:S238-44.
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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.
Theresa J Gustus, PT, DPT, MS principal investigator
Newton-Wellesley Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: LRU Pillow in people with Osteoarthritis, run by Newton-Wellesley Hospital 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: status not confirmed, as of the sponsor's last update on 9 Oct 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (time frame: 3 Days). 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 NCT01814033, 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 9 Oct 2015.