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| Name | Class |
|---|---|
| Universidad Miguel Hernandez de Elche | OTHER |
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The functional outcome and longevity of total knee arthroplasty (TKA) is still a concern. Despite various developments in TKA designs, including fixed or mobile bearing, cruciate retaining or posterior stabilized, multi or single radius, it remains unclear which design is superior for achieving a physiological kinematic.
In normal healthy knees the medial and lateral tibial condyles are different: the medial is almost flat while the lateral is somewhat convex. Thus, the movement during flexion is asymmetric: during the flexion, the medial condyle is stable throughout the range of motion while the lateral condyle slides anteroposteriorly with respect to femur). Therefore, the native knee requires a specific degree of rollback of the lateral compartment coupled with a medial pivot, which leads to an external axial rotation of the femur. This rollback is thought to be even more pronounced with increasing knee flexion angles to enable deep flexion without excessive shear forces acting at the patella or overloading the extensor mechanism.
In addition, stability throughout flexion is a crucial element to normal knee function. Most TKA designs removal of the ACL, and the PCL in posterior-stabilized design, but the TKA do not fully restore the function of those ligaments.
Based on this philosophy, the medial pivot TKA was designed to provide better function, patient satisfaction and increased survival.
The objective of this study is to analyze whether the medial pivot design provides better outcome and prosthesis survival than conventional total knee arthroplasty.
Candidates for the study will be consecutive patients eligible for total knee arthroplasty (TKA) at our center. All patients meeting inclusion criteria will be recruited for enrollment into the study. Informed consent will be obtained from the patient prior to randomization.
At that time, each patient will be randomized into one of two groups by an independent staff using computer generated randomization and allocation concealment. The two patient groups will include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medial pivot group | Active Comparator | Device used: medial pivot total knee arthroplasty design |
|
| Conventional group | Active Comparator | Device used: conventional total knee arthroplasty design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| total knee arthroplasty with medial pivot tibial insert or symmetrical insert | Device | standard surgical implantation of total knee arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Knee Society Score | Functional KSS score (range 0-100) with higher scores as better outcome. A good result is defined as 70 points or greater | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alejandro Lizaur-Utrilla, MD, PhD | Contact | +34 966989019 | lizaur1@telefonica.net |
| Name | Affiliation | Role |
|---|---|---|
| Alejandro Lizaur-Utrilla, MD, PhD | Elda University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elda University Hospital | Recruiting | Elda | Alicante | 03600 | Spain |
IPD that underlie results in a publication
6 months after publication
Request to the principal investigator
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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Patients will be treated surgically with a TKA. The two patient groups will include: 1) Study group treated a medial pivot TKA; 2) Control group treated with a conventional TKA.
Patients will be followed at regular postoperative intervals by orthopaedic surgeons not involved in the surgeries or cares.
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Double Blind. Patients will be allocated into two groups based on randomized 20-block method by an independent assistant using computer generated randomization. Both patients and evaluators will be blinded with regard to the TKA design.
| D012216 |
| Rheumatic Diseases |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |