Osteoarthritis, KneeNCT03416946

Custom Cutting Block Instrument vs Regular Instrumentation Total Knee Replacement (TKR)

A study testing Visionaire and Traditional in people with Osteoarthritis, Knee, run by Orthopaedic Innovation Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To determine if the use of patient-specific custom cutting blocks for implantation of total knee components results in improved limb alignment and component positioning compared to regular instrumentation. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: Visionaire and Traditional
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteCanada
Study dates: 1 Dec 2011to 1 May 2017
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patient is male or female ages 18 and over.
Patient is having primary total knee replacement
Patient is willing to sign the informed consent and to come for all study visits.

Who cannot join

Deformity of the femur preventing use of the intra-medullary guide utilized in the regular instrumentation set.
Necessity for the use of constrained implants. These types of implants have intra-medullary stems, therefore all bone cuts need to be referenced off intramedullary guides, making image guided bone cuts inappropriate.
Patients undergoing knee replacement revision surgery. Theses types of implants also have stems, making the use of image guided bone cuts inappropriate for the same reasons.
Patients scheduled for bilateral knee surgery (simultaneous or staged)

Trial locations and contacts

1 site in 1 country.

Canada1 site

Concordia Hospital
Winnipeg, Manitoba, R2K 3S8

Other trials in Canada

About this study

Official title: A Double-blinded, Randomized, Controlled Trial of Total Knee Replacement Using Custom Cutting Block Instrument vs Regular Instrumentation

Read the detailed description

This is a randomized controlled trial. Patients will be randomized to have their knee implanted using either the patient-specific custom cutting blocks or the regular instrumentation system. Functional and radiographic outcomes will be assessed in a blinded fashion. The Smith and Nephew Legion Primary® total knee system will be used in both groups; this is an implant with a good long term track record based on the Genesis II design. All surgeons have used and are familiar with the regular instrumentation. They will be instructed in the use of the patient-specific custom cutting blocks prior to study initiation.

Conditions: Osteoarthritis, Knee
Being tested: Visionaire, Traditional
Keywords: Total knee replacement
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VisionaireDevice
Custom cutting block using MRI to create patient specific instrumentations
TraditionalOther
Traditional cutting method

Study groups in NCT03416946
Study group	Role	What they receive
Custom Block Instrumentation	Active comparator	Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system Receives: Device: Visionaire
Traditional Instrumentation	Active comparator	Traditional cutting methods for Total Knee Replacement Receives: Other: Traditional

What is being measured

The primary outcome is the main question the study is designed to answer.

Radiographic Alignment
Using 3 foot standing film
Measured: 8 Weeks
Number of HKA Angle Outliers
The angle formed between the mechanical axes of the femur and tibia create the hip-knee-ankle (HKA) angle.
Measured: 8 Weeks

Secondary outcomes (6)

EuroQol (EQ) Five Dimension (5D) Survey
Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the EQ-5D (patient reported). The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state, this health state is range from 0 to 1.0. Higher scores indicate improved quality of life within each dimension.
Measured: Preoperative, 1 and 2 years
Oxford Knee Score
Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the Oxford 12 scores (patient reported). The score ranges from 0 to 48 with higher scores indicating improved function and less pain.
Measured: Preoperative, 1 and 2 years
Pain Catastrophizing Scale (PCS) Score
Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the PCS (patient reported). The total score ranges from 0 to 52 with higher scores indicating greater pain catastrophizing. Sub-scales will not be used in this study.
Measured: Preoperative, 1 and 2 years
Hip Pain
Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the Pain Visual Analog Scale (VAS). The scale is from 0 to 100, 0=no pain and at 100= worst pain. (patient reported).
Measured: Preoperative, 1 and 2 years
University of California Los Angeles (UCLA) Activity Score
Evaluate change from preoperative baseline to 1 and 2 year post operative in activity level assessments using the UCLA Activity score (patient reported). The scale ranges from 1-10 with higher values associated with more intense activities.
Measured: Preoperative, 1 and 2 years
Patient Satisfaction
Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the Satisfaction Visual Analog Scale (VAS). The scale is from 0 to 100, 0=Not Satisfied and at 100=Satisfied. (patient reported).
Measured: Preoperative, 1 and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20111 May 2017

First posted31 Jan 2018
Study start1 Dec 2011
Primary completion1 May 2017
Study completion1 May 2017

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
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: Randomised
Intervention model: Parallel groups
Model description: The block randomization process will be stratified by surgeon to ensure equal distribution between the two surgical techniques.
Masking: Single blind
Who is masked: Participant
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03416946
Sponsor's protocol ID: HS13322
Status last verified: Sep 2021
First submitted: 13 Dec 2017
Last updated: 4 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Turgeon TR, Cameron B, Burnell CD, Hedden DR, Bohm ER. A double-blind randomized controlled trial of total knee replacement using patient-specific cutting block instrumentation versus standard instrumentation. Can J Surg. 2019 Dec 1;62(6):460-467. doi: 10.1503/cjs.018318.
PubMed 31782643

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blinded, Randomized, Controlled Trial of Total Knee Replacement Using Custom Cutting Block Instrument vs Regular Instrumentation
ClinicalTrials.gov ID: NCT03416946
Acronym / sponsor ID: HS13322
Conditions: Osteoarthritis, Knee
Keywords: Total knee replacement
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Orthopaedic Innovation CentreUniversity, hospital or other
Study start: 1 Dec 2011 (actual)
Primary completion: 1 May 2017 (actual)
Study completion: 1 May 2017 (actual)
First posted: 31 Jan 2018 (actual)
Results: Posted 4 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: The block randomization process will be stratified by surgeon to ensure equal distribution between the two surgical techniques.

Arm	Type	Receives
Custom Block Instrumentation	Active comparator	Device: VisionairePatients-specific custom cutting blocks using the Smith and Nephew Visionaire system
Traditional Instrumentation	Active comparator	Other: TraditionalTraditional cutting methods for Total Knee Replacement

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patient is male or female ages 18 and over.
Patient is having primary total knee replacement
Patient is willing to sign the informed consent and to come for all study visits.

Key exclusion criteria (4 listed)

Deformity of the femur preventing use of the intra-medullary guide utilized in the regular instrumentation set.
Necessity for the use of constrained implants. These types of implants have intra-medullary stems, therefore all bone cuts need to be referenced off intramedullary guides, making image guided bone cuts inappropriate.
Patients undergoing knee replacement revision surgery. Theses types of implants also have stems, making the use of image guided bone cuts inappropriate for the same reasons.
Patients scheduled for bilateral knee surgery (simultaneous or staged)

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
VisionaireCustom cutting block using MRI to create patient specific instrumentations	Device	Custom Block Instrumentation
TraditionalTraditional cutting method	Other	Traditional Instrumentation

Primary outcome

Radiographic Alignment
Time frame: 8 Weeks
Using 3 foot standing film
Number of HKA Angle Outliers
Time frame: 8 Weeks
The angle formed between the mechanical axes of the femur and tibia create the hip-knee-ankle (HKA) angle.

6 secondary outcomes

EuroQol (EQ) Five Dimension (5D) Survey
Time frame: Preoperative, 1 and 2 years
Oxford Knee Score
Time frame: Preoperative, 1 and 2 years
Pain Catastrophizing Scale (PCS) Score
Time frame: Preoperative, 1 and 2 years
Hip Pain
Time frame: Preoperative, 1 and 2 years
University of California Los Angeles (UCLA) Activity Score
Time frame: Preoperative, 1 and 2 years
Patient Satisfaction
Time frame: Preoperative, 1 and 2 years

Results and safety

Results posted to the registry on 4 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Custom Block Instrumentation	25	25
Traditional Instrumentation	29	29

Primary outcome: Radiographic Alignment

Time frame: 8 Weeks. Mean (Standard Deviation). Unit: degree

Measure	Custom Block Instrumentation n = 25	Traditional Instrumentation n = 29
Post-op HKA angle	-1.6 (3.2)	-1.8 (2.7)
Femoral coronal angle	89.4 (1.9)	89.3 (2.5)
Tibial coronal angle	89.2 (1.5)	89.1 (1.6)
Femoral sagittal angle	87.4 (2.2)	87.3 (2.7)
Tibial sagittal angle	3.8 (3.0)	7.7 (3.6)

Custom Block Instrumentation vs Traditional Instrumentation: p = 0.790, t-test, 2 sided

Primary outcome: Number of HKA Angle Outliers

Time frame: 8 Weeks. Number. Unit: outliers

Measure	Custom Block Instrumentation n = 25	Traditional Instrumentation n = 29
Value	6	10

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 Years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Custom Block Instrumentation	4 of 25 (16%)	0 of 25 (0%)	0 of 25
Traditional Instrumentation	1 of 29 (3.4%)	0 of 29 (0%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31782643Turgeon TR, Cameron B, Burnell CD, Hedden DR, Bohm ER. A double-blind randomized controlled trial of total knee replacement using patient-specific cutting block instrumentation versus standard instrumentation. Can J Surg. 2019 Dec 1;62(6):460-467. doi: 10.1503/cjs.018318.
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.

Thomas Turgeon, MD MPH FRCSC principal investigator

Orthopaedic Innovation Centre

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Visionaire and Traditional in people with Osteoarthritis, Knee, run by Orthopaedic Innovation Centre at 1 site in Canada.

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 3 inclusion and 4 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 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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 4 Oct 2021). 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?

Radiographic Alignment (time frame: 8 Weeks). 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?

On the ClinicalTrials.gov record for NCT03416946, which also lists 1 linked publication.

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 4 Oct 2021; AzTrials last refreshed its copy on 27 Oct 2026.