Primary Osteoarthritis Patients Scheduled for Total Knee Replacement SurgeryNCT07023185
Cold and Compression Post TKA
A study testing Cold and Compression in people with Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery, run by Ochsner Health System at 1 site in United States.
Trial summary
The purpose of this study is to compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups pre-surgically, daily after surgery for 14 days, then weekly after surgery for 3 months, and at 6 months post-surgery. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery
- What is being tested?
- Cold and Compression
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 50 yr or older
- Patient of Dr. Howard Hirsch or Dr. Vinod Dasa scheduled for total knee arthroplasty (knee replacement) at Ochsner Kenner
- Will receive outpatient physical therapy at OTW Driftwood for the entire post-op rehabilitation period
- English speaking
- Diagnosis of primary osteoarthritis
Who cannot join
- Chronic opioid use
- Opioid use within the last 3 months
- PCS score ≥ 30
- Diagnosis of inflammatory disease process (i.e., gout, rheumatoid arthritis, systematic lupus erythematosus...)
- Discharge to skilled nursing
- Cold intolerance related to diseases, like Raynaud's
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- Significant vascular impairment in the affected region
- Current clinical signs of inflammatory phlebitis, venous ulcers, or cellulitis
- Significant risk factors or current clinical signs of embolism (e.g., pulmonary embolus, pulmonary edema, cerebral infarction, atrial fibrillation, endocarditis, myocardial infarction, or atheromatous embolic plaque)
- A condition in which increased venous or lymphatic return is not desired in the affected extremity (e.g., lymphedema after breast cancer or other local carcinoma and/or carcinoma metastasis in the affected extremity).
- Uncontrolled hypertension (physician discretion), cardiac failure, extreme low blood pressure, or decompensated cardiac insufficiency.
- Localized unstable skin condition (e.g., dermatitis, vein ligation, gangrene, or recent skin graft) in the affected region.
- Had recent toe surgery in the affected region
- Current clinical signs in the affected region of significant peripheral edema (e.g., deep vein thrombosis, chronic venous insufficiency, acute compartment syndrome, systemic venous hypertension, congestive heart failure, cirrhosis/liver failure, renal failure).
- An acute, unstable (untreated) fracture in the affected region.
- Any active local or systemic infection.
- Obtunded or with diabetes mellitus, multiple sclerosis, poor circulation, spinal cord injuries, and rheumatoid arthritis
- Areas of skin breakdown or damage (damaged or at-risk skin) producing uneven heat conduction across the skin (e.g., open wound, scar tissue, burn or skin graft). Any open wound must be dressed prior to use of the Polar Care Wave System.
- Presumptive evidence of congestive heart failure
- Pre-existing DVT condition
- Deep acute venal thrombosis (Phlebothrombosis)
- Episodes of pulmonary embolism
- Pulmonary edema
- Acute inflammation of the veins (Thrombophlebitis)
- Decompensated cardiac insufficiency
- Arterial dysregulation
- Erysipelas
- Carcinoma and carcinoma metastasis in the affected extremity
- Decompensated hypertonia
- Acute inflammatory skin diseases or infection
- Venous or arterial occlusive disease
- Medical situations where increased venous or lymphatic return is undesirable
- Poor peripheral circulation
- Severe arteriosclerosis, or active infection
- Known hematological dyscrasias that predispose to thrombosis (e.g., paroxysmal cold hemoglobinuria, cryoglobulinemia, sicklecell disease, serum cold agglutinins).
- Tissues inflamed as a result of recent injury or exacerbation of chronic inflammatory condition.
- Compromised local circulation or neurologic impairment (including paralysis or localized compromise due to multiple surgical procedures or diabetes) in the affected region.
- Cognition or communication impairments that prevent them from giving accurate and timely feedback.
- Cold allergy
- Cold agglutinin disorders like paroxysmal cold hemoglobinuria
- Buerger's disease
- Chilblains
- Cryoglobulinemia
- Sickle cell anemia
- Uncontrolled diabetes (physician discretion)
- Hypersensitivity to cold
- History of cold injury
- Severe cardiovascular disease, anesthetic skin, hypercoagulation disorders, poor circulation, extremities sensitive to pain, extremely low blood pressure that are incapacitated, decreased skin sensitivity, vein ligation or recent skin grafts, or pheochromocytoma.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ochsner Medical Center - Kenner
New Orleans, Louisiana, 70065
Vinod Dasa, MD, 504-412-1705, vdasa@lsuhsc.edu
Nicole Villemarette-Pittman, PhD, nicole.villemarettepittman@ochsner.org
About this study
Official title: Cold and Compression After Total Knee Arthroplasty for Pain Attenuation: A Randomized, Controlled Trial
The purpose of this study is to compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups pre-surgically, daily after surgery for 14 days, then weekly after surgery for 3 months, and at 6 months post-surgery.
- Being tested
- Cold and Compression, SOC (Standard of care)
- Keywords
- total knee replacement, primary osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold and CompressionDevice
External mechanical compression therapy (e.g., compression stockings) has been shown to reduce swelling and risk of deep vein thrombosis in the lower limbs following TKA.12,13 Combining advanced cryotherapy (continuous circulating cold flow) and dynamic compression may offer added benefits than either traditional cryotherapy (e.g., cold packs) or compression (e.g., stockings) alone.
SOC (Standard of care)Other
Patients enrolled in this arm will be discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold therapy (bag of ice or gel pack)
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Arm | Active comparator | Patients in this arm will receive standard therapy post-surgery and discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold therapy (bag of ice or gel pack) Receives: Other: SOC (Standard of care) |
| Cold and Compression | Experimental | Patients in this arm will be discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold \& compression therapy device provided by Sponsor) Receives: Device: Cold and Compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Pain NRS subscale
Compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups
Measured: Enrollment to 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start15 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Osteoarthritis Patients Scheduled for Total Knee Replacement SurgeryStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Collaborators
- BREG, Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023185
- Sponsor's protocol ID
- 2025.069
- Status last verified
- Apr 2026
- First submitted
- 6 Jun 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Currently there are no plans to share the data as there are no data sharing agreements in place with other institutions.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold and Compression After Total Knee Arthroplasty for Pain Attenuation: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07023185
- Acronym / sponsor ID
- 2025.069
- Keywords
- total knee replacement, primary osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Collaborators
- BREG, Inc
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 15 Jun 2025 (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 compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups pre-surgically, daily after surgery for 14 days, then weekly after surgery for 3 months, and at 6 months post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Arm | Active comparator | Other: SOC (Standard of care)Patients in this arm will receive standard therapy post-surgery and discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold therapy (bag of ice or gel pack) |
| Cold and Compression | Experimental | Device: Cold and CompressionPatients in this arm will be discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold \& compression therapy device provided by Sponsor) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 50 yr or older
- Patient of Dr. Howard Hirsch or Dr. Vinod Dasa scheduled for total knee arthroplasty (knee replacement) at Ochsner Kenner
- Will receive outpatient physical therapy at OTW Driftwood for the entire post-op rehabilitation period
- English speaking
- Diagnosis of primary osteoarthritis
Key exclusion criteria (48 listed)
- Chronic opioid use
- Opioid use within the last 3 months
- PCS score ≥ 30
- Diagnosis of inflammatory disease process (i.e., gout, rheumatoid arthritis, systematic lupus erythematosus...)
- Discharge to skilled nursing
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 |
|---|---|---|
| Cold and CompressionExternal mechanical compression therapy (e.g., compression stockings) has been shown to reduce swelling and risk of deep vein thrombosis in the lower limbs following TKA.12,13 Combining advanced cryotherapy (continuous circulating cold flow) and dynamic compression may offer added benefits than either traditional cryotherapy (e.g., cold packs) or compression (e.g., stockings) alone. | Device | Cold and Compression |
| SOC (Standard of care)Patients enrolled in this arm will be discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold therapy (bag of ice or gel pack) | Other | Standard of Care Arm |
Primary outcome
PROMIS Pain NRS subscale
Time frame: Enrollment to 6 months post-surgery
Compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Undecided. Currently there are no plans to share the data as there are no data sharing agreements in place with other institutions.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold and Compression in people with Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery, run by Ochsner Health System 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 5 inclusion and 48 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: looking for participants now, as of the sponsor's last update on 2 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vinod Dasa, MD ((504) 412-1705, vdasa@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Pain NRS subscale (time frame: Enrollment to 6 months post-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 2 Apr 2026.