Degenerative Arthritis of Knee Clinical Trial
Official title:
A Multicenter, Randomized, Clinical Outcome of VISIONAIRE™ Patient Matched Technology vs. Standard Surgical Instrumentation in Total Knee Arthroplasty
| NCT number | NCT01084772 |
| Other study ID # | VISSTD01 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 21, 2012 |
| Est. completion date | September 2015 |
| Verified date | March 2020 |
| Source | Smith & Nephew, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The objective of this study is to assess outcomes following TKA, utilizing two surgical techniques. Patients will be randomized to one of two arms: TKA with standard instrumentation and TKA with VISIONAIRE™ patient-matched cutting blocks. Data will be collected at preoperative, operative/discharge, 3 months, 1 year and 2 years after TKA. The secondary objective of this study is to compare the safety, quality of life, and economic outcomes of TKA when these two techniques are utilized. This study does not involve treatment or investigational products, as all components are FDA cleared and are commercially available.
| Status | Terminated |
| Enrollment | 134 |
| Est. completion date | September 2015 |
| Est. primary completion date | April 15, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: Patients must meet all of the inclusion criteria. 1. Patient diagnosed with degenerative arthritis of the knee requiring a unilateral primary TKA. 2. Patient is of legal age to consent and is skeletally mature. 3. Patient is willing to sign and date an ethics-approved consent form. 4. Patient is willing to be available for two-year follow-up postoperatively Exclusion Criteria: Patients must not meet any of the exclusion criteria. 1. Patient is known to have poor bone stock making a TKA unjustifiable. 2. Patient is immuno-suppressed. 3. Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up. 4. Patient is pregnant or may become pregnant during the course of the study. 5. Patient has a history of prior ipsilateral major knee surgery (e.g. arthroplasty, high tibial osteotomy, or tibial plateau fracture). Minor prior procedures such as ACL repair, meniscectomy, or arthroscopy are not excluded. 6. Patient has active, localized or systemic infection. 7. Patient is severely overweight (BMI >40). 8. Patient is a prisoner. 9. Subject has a significant MRI (magnetic resonance imaging) exclusion or contraindication. 10. Patient has had a total joint arthroplasty of the contralateral limb in the last 12 months. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Malabar Orthopaedic Clinic | Windsor | Victoria |
| United States | Slocum Research & Education Foundation | Eugene | Oregon |
| United States | University of Nebraska Medical Center | Omaha | Nebraska |
| United States | Orthopaedic Surgery Specialist, Ltd. | Park Ridge | Illinois |
| United States | Town & Country Orthopedics | Saint Louis | Missouri |
| United States | Southern Illinois University School of Medicine | Springfield | Illinois |
| United States | Wake Forest University School of Medicine | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Smith & Nephew, Inc. |
United States, Australia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Total Score | The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS Total Score (0-100 points) included a combined evaluation of joint motion (0-25 points), instability (0-25 points), alignment (0-25 points), and symptoms (0-25 points). A higher score indicated a better outcome for subjects. | 2 years postoperatively | |
| Primary | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS clinical evaluation included a questionnaire completed by the investigators to assess for pain, stability, flexion contracture, extension lag, and alignment and evaluated based on number of subjects experiencing any of these issues at the 2-year postoperative visit. | 2 years postoperatively | |
| Secondary | Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray | Long radiographic anterior-posterior (AP) (full-leg standing x-rays) of the entire limb are superior for measuring alignment of the knee as the limb mechanical axes may be more precisely computed. For full-leg x-rays, 2 lines were drawn on the radiograph. First, a line was drawn from the center of the femoral head to the center of the femoral intercondylar notch and the line was extended through to the ankle. Second, a line was drawn from the center of the tibial spine to the center of the ankle talus. The angle between the first and second line was measured to determine mechanical alignment and assessed as either neutral (0 degrees) or a number of degrees of varus or valgus. | 3 months postoperative | |
| Secondary | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Evaluation of KOOS questionnaire total scores including categories for symptoms, pain, function of daily living, function of sports and recreational activities, and quality of life. KOOS total scores ranged from 0 to 100, with 0 indicating worst (no function) and 100 indicating no symptoms at all. | Baseline (preoperative), 3 months, 1 year, and 2 years postoperatively | |
| Secondary | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | X-ray evaluations performed to assess for evidence of implant loosening by radiolucencies (> 2 mm). Anterior-posterior (AP) and lateral serial x-ray evaluations were performed. The span of the bone-prosthesis interface, for each component, was broken down into zone systems. The scoring system for each of the 3 components was determined by measuring the radiolucent lines (mm) for each of these zones. | 1 year postoperatively | |
| Secondary | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | X-ray evaluations performed to assess for evidence of implant loosening by lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed. | 1 year postoperatively | |
| Secondary | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | X-ray evaluations performed to assess for evidence of implant loosening by radiolucencies (> 2 mm), lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed. The span of the bone-prosthesis interface, for each component, was broken down into zone systems. The scoring system for each of the 3 components was determined by measuring the radiolucent lines (mm) for each of these zones. | 2 years postoperatively | |
| Secondary | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | X-ray evaluations performed to assess for evidence of implant loosening by lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed. | 2 years postoperatively | |
| Secondary | Evaluation of Health Economic Criteria - Surgical Time Details | Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used. | During and immediately following surgery | |
| Secondary | Evaluation of Health Economic Criteria - Blood Loss | Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used. | During and immediately following surgery | |
| Secondary | Evaluation of Health Economic Criteria - Incision Length | Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used. | During and immediately following surgery | |
| Secondary | Evaluation of Health Economic Criteria - Instrument Tray Use | Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used. | During and immediately following surgery | |
| Secondary | Evaluation of Health Economic Surgical Criteria | Analysis of health data captured during and immediately following surgery: surgical approach, cut order, final status of posterior cruciate ligament (PCL), and need for perioperative prophylaxis antibiotics. | During and immediately following surgery |