Degenerative Arthritis of KneeNCT01084772
Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA)
A study testing VISIONAIRE Total Knee Arthroplasty and Standard Total Knee Arthroplasty in people with Degenerative Arthritis of Knee, run by Smith & Nephew, Inc. at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Degenerative Arthritis of Knee
- What is being tested?
- VISIONAIRE Total Knee Arthroplasty and Standard Total Knee Arthroplasty
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 21 Jun 2012to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must meet all of the inclusion criteria.
- Patient diagnosed with degenerative arthritis of the knee requiring a unilateral primary TKA.
- Patient is of legal age to consent and is skeletally mature.
- Patient is willing to sign and date an ethics-approved consent form.
- Patient is willing to be available for two-year follow-up postoperatively
Who cannot join
- Patients must not meet any of the exclusion criteria.
- Patient is known to have poor bone stock making a TKA unjustifiable.
- Patient is immuno-suppressed.
- Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
- Patient is pregnant or may become pregnant during the course of the study.
- 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.
Show all 11Show fewer
- Patient has active, localized or systemic infection.
- Patient is severely overweight (BMI >40).
- Patient is a prisoner.
- Subject has a significant MRI (magnetic resonance imaging) exclusion or contraindication.
- Patient has had a total joint arthroplasty of the contralateral limb in the last 12 months.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Slocum Research & Education Foundation
Eugene, Oregon, 97401
University of Nebraska Medical Center
Omaha, Nebraska, 68198-1080
Orthopaedic Surgery Specialist, Ltd.
Park Ridge, Illinois, 60068
Southern Illinois University School of Medicine
Springfield, Illinois, 62794-9679
Town & Country Orthopedics
St Louis, Missouri, 63131
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157-1070
About this study
Official title: A Multicenter, Randomized, Clinical Outcome of VISIONAIRE™ Patient Matched Technology vs. Standard Surgical Instrumentation in Total Knee Arthroplasty
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.
Read the detailed description
This is a prospective study comparing VISIONAIRE™ to standard TKA instrumentation. The objective of this study is to evaluate the safety and efficacy of TKA using VISIONAIRE™ when compared with standard instrumentation, including device survival, improvement in function and implant alignment after TKA. This study will also document any device-related, surgical complications and/or adverse radiographic observations.
In contrast with the control group clinical outcomes following TKA completed with VISIONAIRE™ have yet to be assessed. The current investigation will determine if there is any difference in TKA outcomes when VISIONAIRE™ patient matched technology is utilized versus standard instrumentation. All patients meeting the inclusion/exclusion criteria specified in this protocol will be asked to participate in the study. If the patient consents to participate, they will be enrolled in the study and randomized to one of the two study arms. Patients requiring TKA will be implanted with Legion, Genesis II or Journey BCS (Smith \& Nephew) total knee implant systems. Standard instrumentation will be used to assist the surgeon in placing the implant in the control group. In the VISIONAIRE™ group, standard instrumentation will not be used in the surgery. Patients randomized to the VISIONAIRE™ arm will have an MRI preoperatively that will be used to create the customized cutting blocks. All patients will have an x-ray at each postoperative interval.
- Conditions
- Degenerative Arthritis of Knee
- Being tested
- VISIONAIRE Total Knee Arthroplasty, Standard Total Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VISIONAIRE Total Knee ArthroplastyOther
TKA will be performed with VISIONAIRE instrumentation, depending on randomization assignment.
Standard Total Knee ArthroplastyOther
TKA will be performed with standard instrumentation, depending on randomization assignment.
| Study group | Role | What they receive |
|---|---|---|
| VISIONAIRE Instrumentation | Other | TKA with VISIONAIRE instrumentation Receives: Other: VISIONAIRE Total Knee Arthroplasty |
| Standard Instrumentation | Other | TKA with standard instrumentation Receives: Other: Standard Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years postoperatively
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.
Measured: 2 years postoperatively
Secondary outcomes (11)
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.
Measured: 3 months postoperative
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.
Measured: Baseline (preoperative), 3 months, 1 year, and 2 years postoperatively
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.
Measured: 1 year postoperatively
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.
Measured: 1 year postoperatively
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.
Measured: 2 years postoperatively
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.
Measured: 2 years postoperatively
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.
Measured: During and immediately following surgery
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.
Measured: During and immediately following surgery
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.
Measured: During and immediately following surgery
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.
Measured: During and immediately following surgery
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.
Measured: During and immediately following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study start21 Jun 2012
- Primary completion15 Apr 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Degenerative Arthritis of KneeStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beate Hanson, MD, PhD, Study director, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084772
- Sponsor's protocol ID
- VISSTD01
- Status last verified
- Mar 2020
- First submitted
- 19 Feb 2010
- Last updated
- 3 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Clinical Outcome of VISIONAIRE™ Patient Matched Technology vs. Standard Surgical Instrumentation in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01084772
- Acronym / sponsor ID
- VISSTD01
- Conditions
- Degenerative Arthritis of Knee
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2012 (actual)
- Primary completion
- 15 Apr 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Posted 3 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective study comparing VISIONAIRE™ to standard TKA instrumentation. The objective of this study is to evaluate the safety and efficacy of TKA using VISIONAIRE™ when compared with standard instrumentation, including device survival, improvement in function and implant alignment after TKA. This study will also document any device-related, surgical complications and/or adverse radiographic observations.
In contrast with the control group clinical outcomes following TKA completed with VISIONAIRE™ have yet to be assessed. The current investigation will determine if there is any difference in TKA outcomes when VISIONAIRE™ patient matched technology is utilized versus standard instrumentation. All patients meeting the inclusion/exclusion criteria specified in this protocol will be asked to participate in the study. If the patient consents to participate, they will be enrolled in the study and randomized to one of the two study arms. Patients requiring TKA will be implanted with Legion, Genesis II or Journey BCS (Smith \& Nephew) total knee implant systems. Standard instrumentation will be used to assist the surgeon in placing the implant in the control group. In the VISIONAIRE™ group, standard instrumentation will not be used in the surgery. Patients randomized to the VISIONAIRE™ arm will have an MRI preoperatively that will be used to create the customized cutting blocks. All patients will have an x-ray at each postoperative interval.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VISIONAIRE Instrumentation | Other | Other: VISIONAIRE Total Knee ArthroplastyTKA with VISIONAIRE instrumentation |
| Standard Instrumentation | Other | Other: Standard Total Knee ArthroplastyTKA with standard instrumentation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must meet all of the inclusion criteria.
- Patient diagnosed with degenerative arthritis of the knee requiring a unilateral primary TKA.
- Patient is of legal age to consent and is skeletally mature.
- Patient is willing to sign and date an ethics-approved consent form.
- Patient is willing to be available for two-year follow-up postoperatively
Key exclusion criteria (11 listed)
- Patients must not meet any of the exclusion criteria.
- Patient is known to have poor bone stock making a TKA unjustifiable.
- Patient is immuno-suppressed.
- Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
- Patient is pregnant or may become pregnant during the course of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VISIONAIRE Total Knee ArthroplastyTKA will be performed with VISIONAIRE instrumentation, depending on randomization assignment. | Other | VISIONAIRE Instrumentation |
| Standard Total Knee ArthroplastyTKA will be performed with standard instrumentation, depending on randomization assignment. | Other | Standard Instrumentation |
Primary outcome
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Total Score
Time frame: 2 years postoperatively
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.
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Time frame: 2 years postoperatively
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.
11 secondary outcomes
Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray
Time frame: 3 months postoperative
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
Time frame: Baseline (preoperative), 3 months, 1 year, and 2 years postoperatively
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Time frame: 1 year postoperatively
Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
Time frame: 1 year postoperatively
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Time frame: 2 years postoperatively
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Time frame: 2 years postoperatively
Evaluation of Health Economic Criteria - Surgical Time Details
Time frame: During and immediately following surgery
Evaluation of Health Economic Criteria - Blood Loss
Time frame: During and immediately following surgery
Evaluation of Health Economic Criteria - Incision Length
Time frame: During and immediately following surgery
Evaluation of Health Economic Criteria - Instrument Tray Use
Time frame: During and immediately following surgery
Evaluation of Health Economic Surgical Criteria
Time frame: During and immediately following surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beate Hanson, MD, PhD study director
Smith & Nephew, Inc.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VISIONAIRE Total Knee Arthroplasty and Standard Total Knee Arthroplasty in people with Degenerative Arthritis of Knee, run by Smith & Nephew, Inc. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Total Score (time frame: 2 years postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.