Osteoarthritis, KneeVISHE13NCT02158819
Visionaire Health Economics Study Comparing Economic Outcomes Between Visionaire and Standard Instrumentation
A study testing Total knee arthroplasty with Visionaire in people with Osteoarthritis, Knee, run by Smith & Nephew, Inc. at 5 sites in South Africa.
Trial summary
The purpose and primary objective of this study is to compare health economic outcomes between the use of a patient-matched cutting guide (Visionaire) versus the use of standard instrumentation in Total Knee Arthroplasty(TKA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Total knee arthroplasty with Visionaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 5 sitesSouth Africa
- Study dates
- 9 Jul 2014to 15 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Degenerative arthritis of the knee requiring unilateral primary Total Knee Arthroplasty in subjects for whom the use of patient-matched cutting guides or standard instrumentation are, in the surgeon's opinion, clinically appropriate and acceptable forms of treatment;
- Patient is of legal age to consent and is skeletally mature;
- The patient is able to fully understand the purpose of the trial, and his/her role as a participant in the study
- The patient consents to his/her inclusion in the study after the nature, scope and possible consequences of the study have been explained in an understandable form.
Who cannot join
- Patient is known to have poor bone stock making a Total Knee Arthroplasty unjustifiable.
- Patient is immuno-suppressed.
- Patient has physical, emotional or neurological conditions that would compromise the subject's compliance with postoperative rehabilitation and follow-up.
- Patient is pregnant or may become pregnant during the course of the study, or is lactating.
- 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 Anterior Cruciate Ligament repair, meniscectomy, or arthroscopy are not excluded.
- Patient has active, localized or systemic infection.
Show all 12Show fewer
- Patient is severely overweight (BMI >40).
- Patient is a prisoner.
- Patient 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.
- Patient presently identified with future need for bilateral TKA within the next twenty-four months.
- Patient has a known or suspected hypersensitivity/allergy to foreign materials contained in the implant
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Africa5 sites
Life Claremont Hospital
Cape Town, Western Cape
Private Practice
Durban, KwaZulu-Natal, 4001
Sunninghill Hospital
Johannesburg, Gauteng
Life Bay View Hospital
Mossel Bay, Cape Town, 6506
Pretoria East Hospital
Pretoria, Gauteng
About this study
Official title: A Prospective, Randomised Pilot Study to Compare Health Economic Outcomes Using a Patient-matched Cutting Guide Versus Standard Instrumentation in Total Knee Arthroplasty.
The purpose and primary objective of this study is to compare health economic outcomes between the use of a patient-matched cutting guide (Visionaire) versus the use of standard instrumentation in Total Knee Arthroplasty(TKA). Data will be collected pre-operatively, intra-operatively and post operatively up until and including the six week post-operative assessment. The secondary objectives of the study are to compare safety and early readmission rates between the two techniques. The study hypothesis is that there is no difference in the cost of the episode of care from hospital admission to discharge, including pre-operative radiology costs and cost of resources, with the Visonaire patient-matched cutting guide compared to standard instrumentation.
Read the detailed description
This is a prospective, randomised pilot study comparing the health economic outcomes between TKA using standard instrumentation and TKA using a patient-matched cutting guide. The primary indication for this study is degenerative arthritis of the knee requiring unilateral primary total knee arthroplasty. Patients requiring TKA who are eligible and have consented to participate will be randomised to TKA with The Genesis II™ Total Knee Implant System or the Legion™ Primary Total Knee System using either Visionaire™ patient-matched cutting guides or standard instrumentation. The study will recruit for 1 year and patients will have a final follow up at the six week post-operative assessment.
The primary objective of this study will evaluate the cost of the episode of care from hospital admission to discharge. This will include pre-operative costs, anesthetic costs, operative and theatre costs, costs of instruments and resources. The study will also measure length of stay as well as blood transfusion requirements. The secondary objectives of this study are to compare the safety and early readmission rates between the two techniques, by measuring the complication rates intra-operatively and post-operatively as well as the number of patients readmitted to hospital prior to the six week post-operative assessment.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Total knee arthroplasty with Visionaire
- Keywords
- Visionaire, Health Economics, Degenerative arthritis, total knee arthroplasty
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplasty with VisionaireDevice
Patient Specific Instrumentation
| Study group | Role | What they receive |
|---|---|---|
| TKA with standard instrumentation | No intervention | This arm consists of the Genesis II Total knee implant system or the Legion Primary total knee system with standard instrumentation |
| Total knee arthroplasty with Visionaire | Active comparator | This arm will consist of the Genesis II Total Knee Implant System or Legion Primary Total Knee System with the Visionaire patient-matched instrumentation Receives: Device: Total knee arthroplasty with Visionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost of the episode of care from admission to hospital to discharge
The cost of the episode of care from admission to hospital to discharge , including pre-operative radiology costs and costs associated with Visionaire and will incorporate the costs of time, number of instruments utilised, blood transfusion requirements, length of stay and pre-operative xray and MRI costs.
Measured: up to 1 week
Secondary outcomes (1)
Percentage of patients that experience short term complications and/or early readmissions
Percentage of patients experiencing intra-operative complications, post operative complications, post discharge complications or readmissions prior to the 6 week post-operative assessment.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study start9 Jul 2014
- Primary completion15 May 2017
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Baker, Principal investigator, Private PracticeLieth Stewart, Principal investigator, Life Claremont HospitalWillem Tollig, Principal investigator, Pretoria East HospitalMichael Barrow, Principal investigator, Sunninghill HospitalDan Potgieter, Principal investigator, Life Bay View Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158819
- Sponsor's protocol ID
- VISHE.13
- Acronym
- VISHE13
- Status last verified
- Jan 2019
- First submitted
- 5 Jun 2014
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised Pilot Study to Compare Health Economic Outcomes Using a Patient-matched Cutting Guide Versus Standard Instrumentation in Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT02158819
- Acronym / sponsor ID
- VISHE13 / VISHE.13
- Conditions
- Osteoarthritis, Knee
- Keywords
- Visionaire, Health Economics, Degenerative arthritis, total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2014 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 9 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose and primary objective of this study is to compare health economic outcomes between the use of a patient-matched cutting guide (Visionaire) versus the use of standard instrumentation in Total Knee Arthroplasty(TKA). Data will be collected pre-operatively, intra-operatively and post operatively up until and including the six week post-operative assessment. The secondary objectives of the study are to compare safety and early readmission rates between the two techniques. The study hypothesis is that there is no difference in the cost of the episode of care from hospital admission to discharge, including pre-operative radiology costs and cost of resources, with the Visonaire patient-matched cutting guide compared to standard instrumentation.
Detailed description
This is a prospective, randomised pilot study comparing the health economic outcomes between TKA using standard instrumentation and TKA using a patient-matched cutting guide. The primary indication for this study is degenerative arthritis of the knee requiring unilateral primary total knee arthroplasty. Patients requiring TKA who are eligible and have consented to participate will be randomised to TKA with The Genesis II™ Total Knee Implant System or the Legion™ Primary Total Knee System using either Visionaire™ patient-matched cutting guides or standard instrumentation. The study will recruit for 1 year and patients will have a final follow up at the six week post-operative assessment.
The primary objective of this study will evaluate the cost of the episode of care from hospital admission to discharge. This will include pre-operative costs, anesthetic costs, operative and theatre costs, costs of instruments and resources. The study will also measure length of stay as well as blood transfusion requirements. The secondary objectives of this study are to compare the safety and early readmission rates between the two techniques, by measuring the complication rates intra-operatively and post-operatively as well as the number of patients readmitted to hospital prior to the six week post-operative assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TKA with standard instrumentation | No intervention | –This arm consists of the Genesis II Total knee implant system or the Legion Primary total knee system with standard instrumentation |
| Total knee arthroplasty with Visionaire | Active comparator | Device: Total knee arthroplasty with VisionaireThis arm will consist of the Genesis II Total Knee Implant System or Legion Primary Total Knee System with the Visionaire patient-matched instrumentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Degenerative arthritis of the knee requiring unilateral primary Total Knee Arthroplasty in subjects for whom the use of patient-matched cutting guides or standard instrumentation are, in the surgeon's opinion, clinically appropriate and acceptable forms of treatment;
- Patient is of legal age to consent and is skeletally mature;
- The patient is able to fully understand the purpose of the trial, and his/her role as a participant in the study
- The patient consents to his/her inclusion in the study after the nature, scope and possible consequences of the study have been explained in an understandable form.
Key exclusion criteria (12 listed)
- Patient is known to have poor bone stock making a Total Knee Arthroplasty unjustifiable.
- Patient is immuno-suppressed.
- Patient has physical, emotional or neurological conditions that would compromise the subject's compliance with postoperative rehabilitation and follow-up.
- Patient is pregnant or may become pregnant during the course of the study, or is lactating.
- 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 Anterior Cruciate Ligament repair, meniscectomy, or arthroscopy are not excluded.
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 |
|---|---|---|
| Total knee arthroplasty with VisionairePatient Specific Instrumentation | Device | Total knee arthroplasty with Visionaire |
Primary outcome
Cost of the episode of care from admission to hospital to discharge
Time frame: up to 1 week
The cost of the episode of care from admission to hospital to discharge , including pre-operative radiology costs and costs associated with Visionaire and will incorporate the costs of time, number of instruments utilised, blood transfusion requirements, length of stay and pre-operative xray and MRI costs.
1 secondary outcome
Percentage of patients that experience short term complications and/or early readmissions
Time frame: up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Andrew Baker principal investigator
Private Practice
Lieth Stewart principal investigator
Life Claremont Hospital
Willem Tollig principal investigator
Pretoria East Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty with Visionaire in people with Osteoarthritis, Knee, run by Smith & Nephew, Inc. at 5 sites in South Africa.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Africa. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cost of the episode of care from admission to hospital to discharge (time frame: up to 1 week). 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 8 Jan 2019.