Cold and Compression Post TKA

ConditionPrimary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age50+

SponsorOchsner Health System

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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...)

Trial design

Design model

Parallel

Treatments tested in this trial

Cold and Compression
Device
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 intervention
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)

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: Standard of Care ArmActive comparator 1 intervention

Group B: Cold and CompressionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

PROMIS Pain NRS subscale

Compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups

Time frame

Enrollment to 6 months post-surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ochsner Health System

Lead sponsor

BREG, Inc

Collaborator

Source ClinicalTrials.gov

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