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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01084772




Registration number
NCT01084772
Ethics application status
Date submitted
19/02/2010
Date registered
10/03/2010
Date last updated
3/04/2020

Titles & IDs
Public title
Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA)
Scientific title
A Multicenter, Randomized, Clinical Outcome of VISIONAIRE™ Patient Matched Technology vs. Standard Surgical Instrumentation in Total Knee Arthroplasty
Secondary ID [1] 0 0
VISSTD01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative Arthritis of Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - VISIONAIRE Total Knee Arthroplasty
Other interventions - Standard Total Knee Arthroplasty

Other: VISIONAIRE Instrumentation - TKA with VISIONAIRE instrumentation

Other: Standard Instrumentation - TKA with standard instrumentation


Other interventions: VISIONAIRE Total Knee Arthroplasty
TKA will be performed with VISIONAIRE instrumentation, depending on randomization assignment.

Other interventions: Standard Total Knee Arthroplasty
TKA will be performed with standard instrumentation, depending on randomization assignment.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
2 years postoperatively
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
2 years postoperatively
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
3 months postoperative
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline (preoperative), 3 months, 1 year, and 2 years postoperatively
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
1 year postoperatively
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
1 year postoperatively
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
2 years postoperatively
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
2 years postoperatively
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
During and immediately following surgery
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
During and immediately following surgery
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
During and immediately following surgery
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
During and immediately following surgery
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
During and immediately following surgery

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Malabar Orthopaedic Clinic - Windsor
Recruitment postcode(s) [1] 0 0
3181 - Windsor
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
Nebraska
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Smith & Nephew, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01084772
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Beate Hanson, MD, PhD
Address 0 0
Smith & Nephew, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01084772