A Comparison of Two Surgical Techniques Using the Unity K... | NCT03511144

Studies
A Comparison of Two Surgical Techniques Using the Unity Knee™ Total Knee System

NCT03511144

Sponsor

Corin

Status

Withdrawn

Last Update Posted

Nov 21, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Osteoarthritis, Knee
Rheumatoid Arthritis
Post-Traumatic Osteoarthritis of Knee
Varus Deformity, Not Elsewhere Classified, Knee
Valgus Deformity, Not Elsewhere Classified, Knee
Flexion Deformity, Knee
Fracture of Distal End of Femur
Fracture of Upper End of Tibia

Interventions

Unity Knee™ TKR using measured resection
Unity Knee™ TKR using ligament balancing

Countries

Not provided

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

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study not initiated

Expanded Access Info

Start Date

Jul 2018Estimated

Primary Completion Date

Sep 2019Estimated

Completion Date

Jul 2020Estimated

First Submitted Date

Apr 11, 2018

First Submission Date that Met QC Criteria

Apr 24, 2018

First Posted Date

Apr 27, 2018Actual

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

Nov 20, 2018

Last Update Posted Date

Nov 21, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Measured resection	Active Comparator	Total knee replacement using the Unity Knee™ implanted with the measured resection surgical technique	Device: Unity Knee™ TKR using measured resection
Ligament balancing	Active Comparator	Total knee replacement using the Unity Knee™ implanted with the ligament balancing surgical technique	Device: Unity Knee™ TKR using ligament balancing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Unity Knee™ TKR using measured resection	Device	Total knee replacement using the Unity Knee™ implanted with the measured resection surgical technique	Measured resection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Posterior condylar offset (PCO)	Any difference in PCO from preoperative to 6 weeks post-surgery	6 weeks post-op

Secondary Outcomes

Measure	Description	Time Frame
Joint line in extension	Any difference in vertical distance from medial epicondyle to distal medial femoral condyle articular surface from preoperative to 6 weeks post-surgery	6 weeks post-op
Joint line in flexion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects suitable for the Unity Knee™ Total Knee System according to the product "Instructions for use"
Over 18 years old
Male and female subjects who are skeletally mature
Subjects who have a smartphone (iOS or Android) with internet connection via mobile Internet data or Wi-Fi connection
Subjects able to understand what is expected of them and be able to comply with the study protocol requirements

Exclusion Criteria:

Any subject listed for a revision total knee replacement or conversion of a unicondylar replacement to a total knee replacement on the operative knee
Any subject with fixed flexion contracture greater than 20 degrees
Any subject with varus/valgus deformity greater than 15 degrees
Any subject with confirmed osteoarthritis or other pathologies affecting the contralateral knee that is anticipated to require surgery within 12 months
Any subjects with contralateral knee replacement that is anticipated to require revision surgery within 12 months
Any subject whose prospects for a recovery to independent mobility would be compromised by known co-existent, medical problems
Any subject with a known sensitivity to device material
Any subject who is pregnant
Any subject currently a prisoner
Any subject known to be a drug or alcohol abuser, or have a psychological disorder that could affect follow-up care or treatment outcomes
Any subject currently involved in any personal injury litigation, medical-legal or worker's compensations claims
Any subject unable to read and understand English

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D020370	Osteoarthritis, Knee
D001172	Arthritis, Rheumatoid

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases