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The purpose of this study is to evaluate the efficacy of cryoablation use on patient-reported outcomes (PROMs) and opioid consumption following total knee arthroplasty. This is a randomized study that will involve a 1:1 randomization to total knee arthroplasty +/- cryoablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total knee arthroplasty (TKA) + Cryoablation | Experimental | Patients will receive cryoablation during the two to three weeks prior to the TKA procedure. |
|
| TKA Only | Active Comparator | Patients will NOT receive cryoablation prior to the TKA procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee arthroplasty (TKA) | Procedure | Administered as part of patient standard of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption during Post-Procedural Follow-Up Period | Measured as morphine milligram equivalents. | Month 3 Post-Operation (Approximately Week 8-9) |
| Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score | KOOS, JR. is a 7-item assessment of how participants feel about their knee and how well they are able to do usual activities. Each item is rated on a Likert scale; the raw score is the sum of item responses. The raw score is transformed into a total score ranging from 0-100, where 0 indicates total knee disability and 100 represents perfect knee health. | Month 3 Post-Operation (Approximately Week 8-9) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Waren | Contact | 212-598-6245 | Daniel.waren@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Joshua Rozell, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Daniel.waren@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Daniel.waren@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| D003452 | Cryosurgery |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Cryoablation | Device | Cryoablation will be administered on the leg of the knee indicated for surgery. |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
| D055011 | Ablation Techniques |