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This study aims to compare the clinical impact of Constrained Condylar versus Posterior Stabilized Knee (PS) bearings on patient satisfaction and surgical outcomes including mid-term survivorship among patients undergoing revision total knee arthroplasty.
The primary purpose of this study is to determine whether a difference exists in clinical patient reported outcomes between CCK or PS bearings following rTKA. A secondary goal of the study is to compare both bearings in survivorship free of revision surgery as well as other surgical complications including instability, in early to mid-term follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Constrained condylar (CCK) | Active Comparator | Once patient meets inclusion criteria, they'll be randomized prior to surgery to a specific CCK implant design. All surgeries will be done at the approved hospital or ASC and if the allocated component isn't used, the patient will still be followed post operatively and remain in the study. |
|
| Posterior Stabilized (PS) bearing | Active Comparator | Once patient meets inclusion criteria, they'll be randomized prior to surgery to a specific PS implant design. All surgeries will be done at the approved hospital or ASC and if the allocated component isn't used, the patient will still be followed post operatively and remain in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Constrained Condylar bearing | Device | Patients in this intervention will receive a CCK bearing component |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical patient reported outcomes | patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS) | 6 weeks post op |
| Clinical patient reported outcomes | Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS) | 1 year post op |
| Clinical patient reported outcomes | Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS) | 2 year post op |
| Clinical patient reported outcomes | Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS) | 5 year post op |
| Clinical patient reported outcomes | Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS) | 10 year post op |
| Clinical patient reported outcomes |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical reported outcomes (Koos Jr) | patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time | 6 weeks to 20 years post op |
| Range of motion over time |
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Inclusion criteria:
Exclusion Criteria:
Patients undergoing rTKA with a hinged implant, or pre-operatively determined to require CCK bearing rTKA, > 80 years of age, or those requiring rTKA less than 6-weeks from the primary TKA,
Patients undergoing rTKA for bearing exchange only rTKA, isolated tibial component rTKA
Patients with pre-operative diagnosis of extensor mechanism disruption or collateral ligament incompetence or with a compromised soft tissue envelope requiring pre-pre-operative plastic surgery evaluation and planned soft tissue coverage.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omary Behery, MD | Contact | 630-339-2230 | omar.behery@rushortho.com | |
| Anne DeBenedetti, MSc | Contact | 312-432-2468 | anne.debenedetti@rushortho.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
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Randomized controlled trial with two groups: constrained condylar (CCK) vs posterior stabilized (PS) articulating bearings. These are standard bearings used in revision knees, comparing two types.
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only the patient is blinded ahead of time
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| posterior stabilized bearing | Device | Patients in this intervention will receive a PS bearing component |
|
Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS) |
| 20 year post op |
Patients will have their knee range of motion (ROM) checked prior to revision surgery and at multiple timepoints after surgery
| pre op to 20 years pots op |
| Clinical reported outcomes ( VR-12) | patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time | 6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op |
| Clinical reported outcomes ( Forgotten Joint Score) | patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time | 6 weeks to 20 years post op |
| Clinical reported outcomes (EQ-5D-3L) | patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time | 6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op |