Osteo Arthritis KneeNCT03521869
The Need for Compression Bandage Following Total Knee Arthroplasty A Prospective Randomized Controlled Trial Conducted in Simultaneous Bilateral Total Knee Replacements
A study testing Compression bandage and Gauze dressing in people with Osteo Arthritis Knee, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if applying a compression bandage on the leg alters early outcome following TKA. The primary objective of this study is to evaluate leg swelling by measuring leg circumference following simultaneous bilateral total knee arthroplasty (TKA) with and without the application of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Compression bandage and Gauze dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2014to 2 Jun 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
- Adult, Older adult
Who may be able to join
- All patients receiving elective simultaneous bilateral primary total knee arthroplasty, treated by Rothman physicians at the Thomas Jefferson University Hospital or Rothman Specialty Hospital.
Who cannot join
- Previous venous thromboembolic event.
- Lymph edema in one or both legs.
- BMI > 40
- Prior surgery (other than arthroscopy)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate if applying a compression bandage on the leg alters early outcome following TKA.
The primary objective of this study is to evaluate leg swelling by measuring leg circumference following simultaneous bilateral total knee arthroplasty (TKA) with and without the application of compression bandage.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Compression bandage, Gauze dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression bandageDevice
Compression bandage placed after total knee replacement
Gauze dressingDevice
standard of care gauze dressing placed after total knee replacement
| Study group | Role | What they receive |
|---|---|---|
| Compression bandage group | Active comparator | Not described Receives: Device: Compression bandage |
| Standard gauze group | Active comparator | Not described Receives: Device: Gauze dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
swelling of the knee
Swelling of the leg will be determined by measuring circumference of the leg
Measured: one day following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start13 Nov 2014
- Primary completion2 Jun 2017
- Study completion2 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Only bilateral knee replacements will be utilized so each patient can serve as their internal control
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiffany Morrison, MS, CCRP, Study director, Rothman Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521869
- Sponsor's protocol ID
- 14WHoz
- Status last verified
- Apr 2018
- First submitted
- 30 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Need for Compression Bandage Following Total Knee Arthroplasty A Prospective Randomized Controlled Trial Conducted in Simultaneous Bilateral Total Knee Replacements
- ClinicalTrials.gov ID
- NCT03521869
- Acronym / sponsor ID
- 14WHoz
- Conditions
- Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 13 Nov 2014 (actual)
- Primary completion
- 2 Jun 2017 (actual)
- Study completion
- 2 Jun 2017 (actual)
- First posted
- 11 May 2018 (actual)
- 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 purpose of this study is to evaluate if applying a compression bandage on the leg alters early outcome following TKA.
The primary objective of this study is to evaluate leg swelling by measuring leg circumference following simultaneous bilateral total knee arthroplasty (TKA) with and without the application of compression bandage.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Only bilateral knee replacements will be utilized so each patient can serve as their internal control
| Arm | Type | Receives |
|---|---|---|
| Compression bandage group | Active comparator | Device: Compression bandage |
| Standard gauze group | Active comparator | Device: Gauze dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients receiving elective simultaneous bilateral primary total knee arthroplasty, treated by Rothman physicians at the Thomas Jefferson University Hospital or Rothman Specialty Hospital.
Key exclusion criteria (4 listed)
- Previous venous thromboembolic event.
- Lymph edema in one or both legs.
- BMI > 40
- Prior surgery (other than arthroscopy)
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 |
|---|---|---|
| Compression bandageCompression bandage placed after total knee replacement | Device | Compression bandage group |
| Gauze dressingstandard of care gauze dressing placed after total knee replacement | Device | Standard gauze group |
Primary outcome
swelling of the knee
Time frame: one day following surgery
Swelling of the leg will be determined by measuring circumference of the leg
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 May 2018.
- Individual participant dataSharing planned: No
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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.
Tiffany Morrison, MS, CCRP study director
Rothman Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression bandage and Gauze dressing in people with Osteo Arthritis Knee, run by Rothman Institute Orthopaedics 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 4 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 May 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?
swelling of the knee (time frame: one day following surgery). 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 11 May 2018.