Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this prospective randomized study is to evaluate iAssist with respect to radiographic, clinical and economic outcomes in comparison to conventional instrumentation in primary total knee arthroplasty using the Persona knee system among patients with BMI>=30.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Technique using Persona prosthesis | Active Comparator | The surgeon will realize the implantation of the Persona prosthesis according to the surgical technique. Potential variables such as methodology for determining tibial rotation, measuring of bone cuts, and any intra-operative adjustments will be captured on the operative case report form. |
|
| iAssist Technique using Persona prosthesis | Experimental | iAssist is an electronic displacement sensor based instrumentation system that provides intra-operative verification at each surgical step (bone cuts alignment and resection level); in order to help reduce bone cuts errors. iAssist features simple and intuitive instrumentation that is based on conventional total knee arthroplasty instrumentation. iAssist should take less than 2-3 minutes (on average) to setup |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iAssist Technique using Persona system vs. the conventional technique using Persona system | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| differences in limb alignment | The primary endpoint is defined as Limb alignment as determined using radiographs (A/P long-standing and lateral films) | 12 MONTHS |
| Measure | Description | Time Frame |
|---|---|---|
| difference in Knee Society Score | Assess the differences in Knee Society Score between iAssist and conventional instrumentation in primary TKA procedures. | 12 MONTHS |
| Measure | Description | Time Frame |
|---|---|---|
| difference in Oxford knee score | Assess the differences inOxford knee score between iAssist and conventional instrumentation in primary TKA procedures. | 12 months |
| Operating room time | to compare the operating room time between patients undergoing iAssist vs. conventional instrumentation in primary TKA procedures. |
Inclusion Criteria:
Male or female
Needs a primary TKR on the left or right knee
Diagnose of non-inflammatory degenerative joint disease (e.g., osteoarthritis, post-traumatic arthritis, avascular necrosis, etc.)
Over 18 years old
BMI>=30
Able to:
Presence of varus or valgus deformity of 15 degrees or less.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meir Libergall, Prof. | Contact | 972-2-6777111 | liebergall@hadassah.org.il |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| three hours |
| Blood loss and complications | to compare the blood loss and complications between patients undergoing iAssist vs. conventional instrumentation in primary TKA procedures | 12 months |