Axial Alignment in Patients Operated Using the Visionaire... | NCT01224522

Studies
Axial Alignment in Patients Operated Using the Visionaire Patient Matched Cutting Blocks

NCT01224522

Sponsor

Smith & Nephew Orthopaedics AG

Status

Terminated

Last Update Posted

Apr 14, 2015Estimated

Enrollment

70Actual

Phase

Phase 3

Conditions

Osteoarthritis of the Knee

Interventions

Visionaire
Standard surgical technique

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

protocol deviations

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Aug 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Oct 14, 2010

First Submission Date that Met QC Criteria

Oct 19, 2010

First Posted Date

Oct 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2015

Last Update Posted Date

Apr 14, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

- Title: PATIENT-MATCHED INSTRUMENTATION VS. STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION

Short Title: Visionaire Alignment
Methodology: Monocentric, Single Blinded, Randomized Controlled Trial
Study Duration: November 2010 to July 2014
Study Centres: Leicester General Hospital, United Kingdom (UK)

Detailed Description

Malalignment is one of the main reasons for knee arthroplasty revision. With the use of patient matched cutting block we expect better axial alignment of the components.

Research Objectives:

The primary research objective is to evaluate the axial alignment and component position in TKA with use of Smith & Nephew's VISIONAIRE Patient Matched Technology and to compare with the alignment when standard instrumentation.
Secondary research objectives include assessing the safety and effectiveness of the VISIONAIRE patient matched technology as compared to commonly accepted standard instrumentation in patients suffering from symptomatic osteoarthritis of the knee joint.

- Outcome Measures:
Implant alignment and Component position by means of CT-scans
Knee Society Score
EuroQol-5 Dimensions (EQ-5D)
Knee injury and Osteoarthritis Outcome Score (KOOS)
Oxford Knee Score
Knee-related adverse events
Standard and full leg x-ray
- Number of Subjects: 70 (2*35)
- Enrollment time: 18 months
- Diagnosis and Main Inclusion Criteria: Patients with osteoarthritis of the knee requiring total knee arthroplasty
- Study Product, Dose, Route, Regimen:

VISIONAIRE patient matched technology versus the commonly accepted standard instrumentation for the Genesis II total knee arthroplasty implant

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Visionaire	Experimental	the group who will be operated by the use of Visionaire patient matched cutting blocks	Procedure: Visionaire
Standard Surgical technique	Active Comparator	The group who will be operated by means fo standard surgical technique	Procedure: Standard surgical technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Visionaire	Procedure	Implantation of a Genesis II Total Knee by means of Visionaire patient matched cutting blocks.	Visionaire

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Axial Alignment	Axial alignment will be measured by means of CT scan and long leg x-ray	6 weeks,

Secondary Outcomes

Measure	Description	Time Frame
Clinical effectiveness and safety.	Safety and effectiveness will be measured by means of Knee Society Score, Oxford Score, EQ-5D and radiographic findings	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Indication for TKA, Axial alignment between 10 degrees valgus and 20 degrees varus, BMI <36, patient must be amendable for both Genesis II total knee and Visioniare cutting blocks

Exclusion Criteria:

Insufficient femoral or tibia bone stock, inflammatory arthritis (e.g. rheumatoid arthritis), patient is immunosuppressed, has an active infection (local or systemic), patient has physical, emotional or neurological conditions that would compromise the patients compliance with rehabilitation and follow up.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Urjit Chatterji, MD	Leicester General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leicester General Hospital		Leicester		LE5 4PW	United Kingdom

Type	Date	Date Unknown
Release	Oct 25, 2016
Reset	Dec 16, 2016

Submission Tracking

Estimated Results First Submitted Date

Oct 25, 2016

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 25, 2016			Dec 16, 2016

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

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Browse Branches

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